Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2026-04-16 @ 5:28 PM
Study NCT ID:
NCT02825251
Status:
COMPLETED
Last Update Posted:
2019-11-21
First Post:
2016-07-04
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart Compared to NovoRapid® in Adults With Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061267', 'term': 'Insulin Aspart'}], 'ancestors': [{'id': 'D061266', 'term': 'Insulin, Short-Acting'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@novonordisk.com', 'phone': '(+1) 866-867-7178', 'title': 'Clinical Reporting Anchor and Disclosure (1452)', 'organization': 'Novo Nordisk A/S'}, 'certainAgreement': {'otherDetails': 'At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Week 0 to Week 16 + 7 days. All reported AEs are treatment emergent (i.e., TEAE).', 'description': 'Results are based on the safety analysis set, which included all subjects receiving at least one dose of the IMP or its comparator.', 'eventGroups': [{'id': 'EG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.', 'otherNumAtRisk': 236, 'deathsNumAtRisk': 236, 'otherNumAffected': 84, 'seriousNumAtRisk': 236, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.', 'otherNumAtRisk': 236, 'deathsNumAtRisk': 236, 'otherNumAffected': 72, 'seriousNumAtRisk': 236, 'deathsNumAffected': 0, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Infusion site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numEvents': 26, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 10, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numEvents': 60, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 64, 'numAffected': 50}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}], 'seriousEvents': [{'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Adenovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Device breakage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Hypoglycaemic seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Hypoglycaemic unconsciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Neurodermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Pain management', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Retinal aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Glycosylated Haemoglobin (HbA1c)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.49', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '7.49', 'spread': '0.53', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline', 'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '-0.14', 'spread': '0.44', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.09', 'ciLowerLimit': '0.01', 'ciUpperLimit': '0.17', 'groupDescription': 'Change from baseline in HbA1c was analysed using an analysis of variance model after multiple imputation assuming treatment according to randomisation. The model included treatment, strata (use of own continuous glucose monitoring), previous insulin use, and region as factors, and baseline HbA1c as a covariate.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority of faster aspart was considered confirmed if the upper limit of the two-sided 95 % CI for the true treatment-difference D (faster aspart minus NovoRapid®) was below 0.4 %.'}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in HbA1c was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In-trial period: the observation period from date of randomisation until last trial-related subject-site contact.', 'unitOfMeasure': 'Percentage (%) of HbA1c', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 1-hour PPG Increment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.67', 'spread': '3.09', 'groupId': 'OG000'}, {'value': '4.62', 'spread': '3.00', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.89', 'spread': '3.44', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '3.37', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, Week 16', 'description': 'Change from baseline (week 0) in 1-hour postprandial glucose (PPG) increment was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 1,5-anhydroglucitol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.20', 'spread': '2.34', 'groupId': 'OG000'}, {'value': '4.13', 'spread': '2.14', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.14', 'spread': '1.48', 'groupId': 'OG000'}, {'value': '0.25', 'spread': '1.42', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, Week 16', 'description': 'Change from baseline (week 0) in 1,5-anhydroglucitol was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Time Spent in Low IG (≤3.9 mmol/L [70 mg/dL]) During CGM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '85.42', 'spread': '65.20', 'groupId': 'OG000'}, {'value': '79.88', 'spread': '60.46', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.96', 'spread': '55.29', 'groupId': 'OG000'}, {'value': '2.85', 'spread': '58.56', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in low interstitial glucose (IG) (≤3.9 mmol/L \\[70 mg/dL\\]) during continuous glucose monitoring (CGM) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.', 'unitOfMeasure': 'min/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose (FPG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.60', 'spread': '2.64', 'groupId': 'OG000'}, {'value': '7.40', 'spread': '2.31', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.03', 'spread': '3.19', 'groupId': 'OG000'}, {'value': '0.25', 'spread': '3.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in FPG was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Reaching HbA1c <7.0% (53 mmol/Mol)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.3', 'groupId': 'OG000'}, {'value': '23.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'Percentage of subjects reaching HbA1c \\<7.0% (53 mmol/mol) was evaluated after 16 weeks of randomisation. Subjects without an HbA1c measurement at week 16 were considered not to have achieved HbA1c target at week 16. The results are based on the in-trial period.', 'unitOfMeasure': '% of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Reaching HbA1c <7.0% (53 mmol/Mol) Without Severe Hypoglycaemic Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.6', 'groupId': 'OG000'}, {'value': '22.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'Percentage of subjects reaching HbA1c \\<7.0% (53 mmol/mol) without treatment emergent severe hypoglycaemic episodes was evaluated after 16 weeks of randomisation. Subjects without an HbA1c measurement at week 16 were considered not to have achieved HbA1c target at week 16. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose (PG) concentrations may not be available during an event, but neurological recovery following the return of PG to normal was considered sufficient evidence that the event was induced by a low PG concentration. Treatment emergent: hypoglycaemic episodes were defined as treatment emergent if the onset of the episode occurred on or after the first day of IMP administration after randomisation (in week 0) and no later than one day after the last day on IMP (i.e., maximum week 16 + 1 day). The results are based on the in-trial period.', 'unitOfMeasure': '% of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 30-min, 1-hour, 2-hour, 3-hour and 4-hour PPG (Meal Test)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': '30-min (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.54', 'spread': '3.33', 'groupId': 'OG000'}, {'value': '10.30', 'spread': '2.96', 'groupId': 'OG001'}]}]}, {'title': '1-hour (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.18', 'spread': '3.96', 'groupId': 'OG000'}, {'value': '11.96', 'spread': '3.81', 'groupId': 'OG001'}]}]}, {'title': '2-hour (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.17', 'spread': '4.77', 'groupId': 'OG000'}, {'value': '13.04', 'spread': '4.35', 'groupId': 'OG001'}]}]}, {'title': '3-hour (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.38', 'spread': '4.65', 'groupId': 'OG000'}, {'value': '11.48', 'spread': '4.28', 'groupId': 'OG001'}]}]}, {'title': '4-hour (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.07', 'spread': '4.31', 'groupId': 'OG000'}, {'value': '9.18', 'spread': '3.83', 'groupId': 'OG001'}]}]}, {'title': '30-min (Change from baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.50', 'spread': '4.05', 'groupId': 'OG000'}, {'value': '0.42', 'spread': '3.75', 'groupId': 'OG001'}]}]}, {'title': '1-hour (Change from baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.85', 'spread': '4.65', 'groupId': 'OG000'}, {'value': '0.36', 'spread': '4.58', 'groupId': 'OG001'}]}]}, {'title': '2-hour (Change from baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.80', 'spread': '5.33', 'groupId': 'OG000'}, {'value': '0.42', 'spread': '5.01', 'groupId': 'OG001'}]}]}, {'title': '3-hour (Change from baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.33', 'spread': '5.12', 'groupId': 'OG000'}, {'value': '0.20', 'spread': '4.75', 'groupId': 'OG001'}]}]}, {'title': '4-hour (Change from baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '4.76', 'groupId': 'OG000'}, {'value': '0.21', 'spread': '4.10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour postprandial glucose (PPG \\[meal test\\]) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. Meal test: The subjects were given a carbohydrate-rich standardised liquid meal immediately after bolus (faster aspart or NovoRapid®) infusion in the morning of the meal test. The subjects were to consume the meal as quickly as possible (within 12 minutes) and blood samples were drawn after 30 minutes, 1, 2, 3 and 4 hours from the start of the meal.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 30-min, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': '30-min (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.02', 'spread': '2.16', 'groupId': 'OG000'}, {'value': '2.95', 'spread': '2.03', 'groupId': 'OG001'}]}]}, {'title': '2-hour (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.65', 'spread': '4.12', 'groupId': 'OG000'}, {'value': '5.70', 'spread': '3.66', 'groupId': 'OG001'}]}]}, {'title': '3-hour (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.85', 'spread': '4.32', 'groupId': 'OG000'}, {'value': '4.13', 'spread': '3.72', 'groupId': 'OG001'}]}]}, {'title': '4-hour (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.57', 'spread': '4.23', 'groupId': 'OG000'}, {'value': '1.83', 'spread': '3.52', 'groupId': 'OG001'}]}]}, {'title': '30-min (Change from baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.53', 'spread': '2.47', 'groupId': 'OG000'}, {'value': '0.11', 'spread': '2.25', 'groupId': 'OG001'}]}]}, {'title': '2-hour (Change from baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.82', 'spread': '4.39', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '4.13', 'groupId': 'OG001'}]}]}, {'title': '3-hour (Change from baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.35', 'spread': '4.53', 'groupId': 'OG000'}, {'value': '-0.14', 'spread': '4.07', 'groupId': 'OG001'}]}]}, {'title': '4-hour (Change from baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '4.50', 'groupId': 'OG000'}, {'value': '-0.11', 'spread': '3.76', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in 30-min, 2-hour, 3-hour and 4-hour PPG increment (meal test) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. Meal test: The subjects were given a carbohydrate-rich standardised liquid meal immediately after bolus (faster aspart or NovoRapid®) infusion in the morning of the meal test. The subjects were to consume the meal as quickly as possible (within 12 minutes) and PPG was evaluated after 30 minutes, 1, 2, 3 and 4 hours from the start of the meal.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean of the 7-7-9 Point Self-measured Plasma Glucose (SMPG) Profile', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.24', 'spread': '1.71', 'groupId': 'OG000'}, {'value': '9.10', 'spread': '1.40', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.19', 'spread': '1.91', 'groupId': 'OG000'}, {'value': '0.10', 'spread': '1.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in mean of the 7-7-9 point SMPG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. 7-7-9 point SMPG was measured at the following mentioned time points: 1) Before breakfast, 2) 60 mins after the start of Breakfast, 3) Before lunch, 4) 60 mins after the start of lunch, 5) Before main evening meal, 6) 60 mins after the start of main evening meal, 7) At bedtime, 8) At 4 AM, 9) Before breakfast.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of the 7-7-9 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'Breakfast (baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.82', 'spread': '2.99', 'groupId': 'OG000'}, {'value': '10.28', 'spread': '3.07', 'groupId': 'OG001'}]}]}, {'title': 'Lunch (baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.65', 'spread': '3.05', 'groupId': 'OG000'}, {'value': '9.62', 'spread': '2.68', 'groupId': 'OG001'}]}]}, {'title': 'Main evening meal (baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.79', 'spread': '3.01', 'groupId': 'OG000'}, {'value': '9.34', 'spread': '3.06', 'groupId': 'OG001'}]}]}, {'title': 'Mean over all meals (baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.07', 'spread': '2.09', 'groupId': 'OG000'}, {'value': '9.74', 'spread': '1.99', 'groupId': 'OG001'}]}]}, {'title': 'Breakfast (Change from baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.33', 'spread': '3.61', 'groupId': 'OG000'}, {'value': '0.23', 'spread': '3.79', 'groupId': 'OG001'}]}]}, {'title': 'Lunch (Change from baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.27', 'spread': '3.75', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '3.57', 'groupId': 'OG001'}]}]}, {'title': 'Main evening meal (Change from baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.35', 'spread': '3.81', 'groupId': 'OG000'}, {'value': '0.58', 'spread': '3.61', 'groupId': 'OG001'}]}]}, {'title': 'Mean over all meals (Change from baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.06', 'spread': '2.33', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '2.21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in PPG (breakfast, lunch, main evening meal and mean over all meals) of the 7-7-9 point SMPG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of the 7-7-9 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'Breakfast (baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.62', 'spread': '3.16', 'groupId': 'OG000'}, {'value': '1.93', 'spread': '3.28', 'groupId': 'OG001'}]}]}, {'title': 'Lunch (baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.80', 'spread': '2.77', 'groupId': 'OG000'}, {'value': '1.77', 'spread': '2.47', 'groupId': 'OG001'}]}]}, {'title': 'Main evening meal (baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.04', 'spread': '3.07', 'groupId': 'OG000'}, {'value': '0.52', 'spread': '2.69', 'groupId': 'OG001'}]}]}, {'title': 'Mean over all meals (baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.93', 'spread': '1.94', 'groupId': 'OG000'}, {'value': '1.48', 'spread': '1.86', 'groupId': 'OG001'}]}]}, {'title': 'Breakfast (Change from baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.75', 'spread': '3.90', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '3.67', 'groupId': 'OG001'}]}]}, {'title': 'Lunch (Change from baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.43', 'spread': '3.25', 'groupId': 'OG000'}, {'value': '-0.27', 'spread': '3.13', 'groupId': 'OG001'}]}]}, {'title': 'Main evening meal (Change from baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.47', 'spread': '3.51', 'groupId': 'OG000'}, {'value': '0.35', 'spread': '3.79', 'groupId': 'OG001'}]}]}, {'title': 'Mean over all meals (Change from baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.53', 'spread': '1.99', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '1.92', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in PPG increment (breakfast, lunch, main evening meal and mean over all meals) of the 7-7-9 point SMPG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of the 7-7-9 Point SMPG Profile: Pre-prandial Plasma Glucose (PG) (Mean, Pre-breakfast, Pre-lunch, Pre-main Evening Meal)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'Pre-breakfast (baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '206', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.40', 'spread': '2.50', 'groupId': 'OG000'}, {'value': '8.31', 'spread': '2.32', 'groupId': 'OG001'}]}]}, {'title': 'Pre-lunch (baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.28', 'spread': '2.85', 'groupId': 'OG000'}, {'value': '8.21', 'spread': '2.32', 'groupId': 'OG001'}]}]}, {'title': 'Pre-main evening meal (baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.68', 'spread': '2.76', 'groupId': 'OG000'}, {'value': '8.87', 'spread': '2.62', 'groupId': 'OG001'}]}]}, {'title': 'Pre-mean over all meals (baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.39', 'spread': '1.73', 'groupId': 'OG000'}, {'value': '8.45', 'spread': '1.54', 'groupId': 'OG001'}]}]}, {'title': 'Pre-breakfast (Change from baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.36', 'spread': '3.33', 'groupId': 'OG000'}, {'value': '0.26', 'spread': '3.05', 'groupId': 'OG001'}]}]}, {'title': 'Pre-lunch (Change from baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.39', 'spread': '3.54', 'groupId': 'OG000'}, {'value': '0.21', 'spread': '3.12', 'groupId': 'OG001'}]}]}, {'title': 'Pre-main evening meal (Change from baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.15', 'spread': '3.72', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '3.18', 'groupId': 'OG001'}]}]}, {'title': 'Pre-mean over all meals (Change from baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.39', 'spread': '2.00', 'groupId': 'OG000'}, {'value': '0.21', 'spread': '1.84', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in pre-prandial PG (pre-breakfast, pre-lunch, pre-main evening meal and mean over all meals) of the 7-7-9 point SMPG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of the 7-7-9 Point SMPG Profile: Fluctuation in 7-7-9 Point Profile', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.14', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '4.9'}, {'value': '2.05', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '4.0'}]}]}, {'title': 'Last in-trial value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.06', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '5.2'}, {'value': '2.06', 'groupId': 'OG001', 'lowerLimit': '0.7', 'upperLimit': '3.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 0, week 16', 'description': 'Fluctuation in 7-point SMPG profile was the average absolute difference from the mean of the SMPG profile. Reported results are fluctuation in the 7-7-9 point SMPG profile at baseline (week 0) and after 16 weeks of randomisation (i.e., week 16). The results are based on the last in-trial value, which included the last available measurement in the in-trial period.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of the 7-7-9 Point SMPG Profile: in Nocturnal SMPG Measurements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': '04:00 to breakfast (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.29', 'spread': '3.61', 'groupId': 'OG000'}, {'value': '-1.06', 'spread': '3.35', 'groupId': 'OG001'}]}]}, {'title': 'Bedtime to 04:00 (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.97', 'spread': '5.16', 'groupId': 'OG000'}, {'value': '-0.56', 'spread': '3.84', 'groupId': 'OG001'}]}]}, {'title': 'Bedtime to breakfast (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.73', 'spread': '4.81', 'groupId': 'OG000'}, {'value': '-1.56', 'spread': '3.83', 'groupId': 'OG001'}]}]}, {'title': '04:00 to breakfast (Change from baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.50', 'spread': '4.83', 'groupId': 'OG000'}, {'value': '-0.08', 'spread': '4.45', 'groupId': 'OG001'}]}]}, {'title': 'Bedtime to 04:00 (Change from baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.81', 'spread': '6.59', 'groupId': 'OG000'}, {'value': '0.18', 'spread': '5.14', 'groupId': 'OG001'}]}]}, {'title': 'Bedtime to breakfast (Change from baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.13', 'spread': '6.67', 'groupId': 'OG000'}, {'value': '-0.20', 'spread': '5.84', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in nocturnal SMPG measurements was assessed by considering the differences between PG values available at bedtime, at 4 AM and the before breakfast value the following day: (4 AM PG value minus at bedtime PG value), (before breakfast PG value minus at bedtime PG value) and (before breakfast PG value minus 4 AM PG value). Change from baseline in nocturnal increments in SMPG measurements of the 7-7-9 point SMPG profile was evaluated after 16 weeks of randomisation and presented during three different time intervals as follows: 1) 04:00 to breakfast, 2) bedtime to 04:00, and 3) bedtime to breakfast. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Reaching Overall PPG (1 Hour) ≤7.8 mmol/L [140 mg/dL]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.1', 'groupId': 'OG000'}, {'value': '7.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'Percentage of subjects reaching overall PPG (1 hour) ≤7.8 mmol/L \\[140 mg/dL\\] was evaluated after 16 weeks of randomisation. Subjects without a postprandial glucose measurement at week 16 were considered not to have achieved HbA1c target at week 16. The results are based on the in-trial period.', 'unitOfMeasure': '% of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Reaching Overall PPG (1 Hour) ≤7.8 mmol/L [140 mg/dL] Without Severe Hypoglycaemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.6', 'groupId': 'OG000'}, {'value': '6.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'Percentage of subjects reaching overall PPG (1 hour) ≤7.8 mmol/L \\[140 mg/dL\\] without treatment emergent severe hypoglycaemia was evaluated after 16 weeks of randomisation. Subjects without a postprandial glucose measurement at week 16 were considered not to have achieved HbA1c target at week 16. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose (PG) concentrations may not be available during an event, but neurological recovery following the return of PG to normal was considered sufficient evidence that the event was induced by a low PG concentration. The results are based on the in-trial period.', 'unitOfMeasure': '% of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Lipids-lipoproteins Profile (Total Cholesterol, High Density Lipoproteins, Low Density Lipoproteins)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'Total cholesterol (Baseline)', 'categories': [{'measurements': [{'value': '4.48', 'groupId': 'OG000', 'lowerLimit': '2.6', 'upperLimit': '8.1'}, {'value': '4.68', 'groupId': 'OG001', 'lowerLimit': '2.9', 'upperLimit': '8.0'}]}]}, {'title': 'High density lipoproteins (Baseline)', 'categories': [{'measurements': [{'value': '1.70', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '3.3'}, {'value': '1.71', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': '3.8'}]}]}, {'title': 'Low density lipoproteins (Baseline)', 'categories': [{'measurements': [{'value': '2.46', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '6.4'}, {'value': '2.63', 'groupId': 'OG001', 'lowerLimit': '1.2', 'upperLimit': '6.6'}]}]}, {'title': 'Total cholesterol (Last in-trial value)', 'categories': [{'measurements': [{'value': '4.61', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '7.2'}, {'value': '4.57', 'groupId': 'OG001', 'lowerLimit': '2.4', 'upperLimit': '8.2'}]}]}, {'title': 'High density lipoproteins (Last in-trial value)', 'categories': [{'measurements': [{'value': '1.74', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '3.1'}, {'value': '1.74', 'groupId': 'OG001', 'lowerLimit': '0.7', 'upperLimit': '3.6'}]}]}, {'title': 'Low density lipoproteins (Last in-trial value)', 'categories': [{'measurements': [{'value': '2.56', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '5.2'}, {'value': '2.59', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '6.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 0, week 16', 'description': 'Reported results are lipids-lipoproteins (total cholesterol, high density lipoproteins, low density lipoproteins) values at baseline (week 0) and after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Insulin Dose in Units/Day: Total Basal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.82', 'spread': '12.82', 'groupId': 'OG000'}, {'value': '23.87', 'spread': '11.38', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 16', 'description': 'Total basal insulin dose (Units/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period: the observation period from date of first dose of randomised trial products (faster aspart and NovoRapid®) to no later than 7 days after the day of last dose of randomised trial products.', 'unitOfMeasure': 'Unit (U)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects receiving at least one dose of the investigational medicinal product (IMP, faster aspart) or its comparator (NovoRapid®/NovoLog®). Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Insulin Dose in Units/Day: Total Bolus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.91', 'spread': '17.46', 'groupId': 'OG000'}, {'value': '25.27', 'spread': '15.33', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 16', 'description': 'Total bolus insulin dose (Units/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.', 'unitOfMeasure': 'U', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Insulin Dose in Units/Day: Total Daily Insulin Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '49.72', 'spread': '27.08', 'groupId': 'OG000'}, {'value': '49.12', 'spread': '23.75', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 16', 'description': 'Total insulin dose (Units/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.', 'unitOfMeasure': 'U', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Insulin Dose in Units/Day: Individual Meal Insulin Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'timeFrame': 'Week 16', 'description': 'No data was collected for individual meal insulin dose.', 'reportingStatus': 'POSTED', 'populationDescription': 'No subjects were analysed, as no data was collected for individual meal insulin dose.'}, {'type': 'SECONDARY', 'title': 'Insulin Dose in Units/kg/Day: Total Basal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.30', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '0.30', 'spread': '0.11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 16', 'description': 'Total basal insulin dose (Units/kg/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.', 'unitOfMeasure': 'U/Kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Insulin Dose in Units/kg/Day: Total Bolus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.33', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '0.31', 'spread': '0.16', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 16', 'description': 'Total bolus insulin dose (Units/kg/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.', 'unitOfMeasure': 'U/Kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Insulin Dose in Units/kg/Day: Total Daily Insulin Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.63', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '0.61', 'spread': '0.23', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 16', 'description': 'Total insulin dose (Units/kg/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.', 'unitOfMeasure': 'U/Kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Insulin Dose in Units/kg/Day: Individual Meal Insulin Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'timeFrame': 'Week 16', 'description': 'No data was collected for individual meal insulin dose.', 'reportingStatus': 'POSTED', 'populationDescription': 'No subjects were analysed, as no data was collected for individual meal insulin dose.'}, {'type': 'SECONDARY', 'title': 'Insulin Delivery Pump Parameter: Insulin Carbohydrate Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.13', 'spread': '3.20', 'groupId': 'OG000'}, {'value': '9.74', 'spread': '6.77', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 16', 'description': 'Insulin carbohydrate ratio was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.', 'unitOfMeasure': 'Gram (g)/U', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Insulin Delivery Pump Parameter: Glucose Sensitivity Factor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.65', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '2.60', 'spread': '0.98', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 16', 'description': 'Glucose sensitivity factor was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.', 'unitOfMeasure': 'mmol/L/U', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Insulin Delivery Pump Parameter: Active Insulin Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '0.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 16', 'description': 'Active insulin time was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.', 'unitOfMeasure': 'Hour (h)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'Breakfast 0-30 min (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.23', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '0.21', 'spread': '0.60', 'groupId': 'OG001'}]}]}, {'title': 'Lunch 0-30 min (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.60', 'groupId': 'OG001'}]}]}, {'title': 'Main evening meal 0-30 min (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.15', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '0.57', 'groupId': 'OG001'}]}]}, {'title': 'Mean across all meals 0-30 min (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.37', 'groupId': 'OG000'}, {'value': '0.11', 'spread': '0.39', 'groupId': 'OG001'}]}]}, {'title': 'Breakfast 0-1 h (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.78', 'spread': '0.97', 'groupId': 'OG000'}, {'value': '0.73', 'spread': '0.94', 'groupId': 'OG001'}]}]}, {'title': 'Lunch 0-1 h (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.42', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '0.44', 'spread': '0.84', 'groupId': 'OG001'}]}]}, {'title': 'Main evening meal 0-1 h (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.39', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '0.32', 'spread': '0.82', 'groupId': 'OG001'}]}]}, {'title': 'Mean across all meals 0-1 h (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.52', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '0.50', 'spread': '0.60', 'groupId': 'OG001'}]}]}, {'title': 'Breakfast 0-2 h (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.32', 'spread': '1.52', 'groupId': 'OG000'}, {'value': '1.27', 'spread': '1.46', 'groupId': 'OG001'}]}]}, {'title': 'Lunch 0-2 h (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.99', 'spread': '1.19', 'groupId': 'OG000'}, {'value': '0.92', 'spread': '1.07', 'groupId': 'OG001'}]}]}, {'title': 'Main evening meal 0-2 h (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.54', 'spread': '1.15', 'groupId': 'OG000'}, {'value': '0.50', 'spread': '1.19', 'groupId': 'OG001'}]}]}, {'title': 'Mean across all meals 0-2 h (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.93', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '0.89', 'spread': '0.84', 'groupId': 'OG001'}]}]}, {'title': 'Breakfast 0-30 min (Change from baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '0.67', 'groupId': 'OG001'}]}]}, {'title': 'Lunch 0-30 min (Change from baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '0.10', 'spread': '0.68', 'groupId': 'OG001'}]}]}, {'title': 'Main evening meal 0-30 min (Change from baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.07', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.70', 'groupId': 'OG001'}]}]}, {'title': 'Mean across all meals 0-30min:Change from baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '0.46', 'groupId': 'OG001'}]}]}, {'title': 'Breakfast 0-1 h (Change from baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.13', 'spread': '1.13', 'groupId': 'OG000'}, {'value': '0.14', 'spread': '0.99', 'groupId': 'OG001'}]}]}, {'title': 'Lunch 0-1 h (Change from baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '0.15', 'spread': '0.99', 'groupId': 'OG001'}]}]}, {'title': 'Main evening meal 0-1 h (Change from baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.16', 'spread': '0.95', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.97', 'groupId': 'OG001'}]}]}, {'title': 'Mean across all meals 0-1 h (Change from baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.10', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '0.11', 'spread': '0.66', 'groupId': 'OG001'}]}]}, {'title': 'Breakfast 0-2 h (Change from baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.28', 'spread': '1.60', 'groupId': 'OG000'}, {'value': '0.16', 'spread': '1.45', 'groupId': 'OG001'}]}]}, {'title': 'Lunch 0-2 h (Change from baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.24', 'spread': '1.32', 'groupId': 'OG000'}, {'value': '0.22', 'spread': '1.37', 'groupId': 'OG001'}]}]}, {'title': 'Main evening meal 0-2 h (Change from baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.29', 'spread': '1.29', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '1.27', 'groupId': 'OG001'}]}]}, {'title': 'Mean across all meals 0-2 h (Change from baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.25', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '0.86', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in mean interstitial glucose (IG) increment (0-30 minutes (min), 0-1 hour (h) and 0-2 h after start of meal) (breakfast, lunch, main evening meal and mean across all meals) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Time to the IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'Breakfast (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '88.95', 'spread': '25.66', 'groupId': 'OG000'}, {'value': '97.29', 'spread': '32.32', 'groupId': 'OG001'}]}]}, {'title': 'Lunch (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '109.47', 'spread': '31.78', 'groupId': 'OG000'}, {'value': '106.94', 'spread': '29.67', 'groupId': 'OG001'}]}]}, {'title': 'Main evening meal (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '110.11', 'spread': '32.35', 'groupId': 'OG000'}, {'value': '106.91', 'spread': '29.61', 'groupId': 'OG001'}]}]}, {'title': 'Mean across all meals (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '103.24', 'spread': '18.50', 'groupId': 'OG000'}, {'value': '103.99', 'spread': '19.21', 'groupId': 'OG001'}]}]}, {'title': 'Breakfast (Change from baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.25', 'spread': '33.69', 'groupId': 'OG000'}, {'value': '-4.03', 'spread': '35.49', 'groupId': 'OG001'}]}]}, {'title': 'Lunch (Change from baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.00', 'spread': '38.63', 'groupId': 'OG000'}, {'value': '1.64', 'spread': '38.02', 'groupId': 'OG001'}]}]}, {'title': 'Main evening meal (Change from baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.04', 'spread': '40.51', 'groupId': 'OG000'}, {'value': '-1.43', 'spread': '38.94', 'groupId': 'OG001'}]}]}, {'title': 'Mean across all meals (Change from baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.30', 'spread': '22.01', 'groupId': 'OG000'}, {'value': '-1.00', 'spread': '21.90', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in mean time to the IG peak after start of meal (breakfast, lunch, main evening meal and mean across all meals) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'Breakfast (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.43', 'spread': '1.97', 'groupId': 'OG000'}, {'value': '12.25', 'spread': '2.09', 'groupId': 'OG001'}]}]}, {'title': 'Lunch (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.42', 'spread': '2.07', 'groupId': 'OG000'}, {'value': '12.56', 'spread': '1.84', 'groupId': 'OG001'}]}]}, {'title': 'Main evening meal (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.65', 'spread': '2.10', 'groupId': 'OG000'}, {'value': '12.70', 'spread': '2.06', 'groupId': 'OG001'}]}]}, {'title': 'Mean across all meals (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.49', 'spread': '1.67', 'groupId': 'OG000'}, {'value': '12.51', 'spread': '1.60', 'groupId': 'OG001'}]}]}, {'title': 'Breakfast (Change from baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.10', 'spread': '2.24', 'groupId': 'OG000'}, {'value': '0.11', 'spread': '2.11', 'groupId': 'OG001'}]}]}, {'title': 'Lunch (Change from baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.10', 'spread': '2.19', 'groupId': 'OG000'}, {'value': '0.19', 'spread': '1.92', 'groupId': 'OG001'}]}]}, {'title': 'Main evening meal (Change from baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.22', 'spread': '2.09', 'groupId': 'OG000'}, {'value': '-0.13', 'spread': '2.14', 'groupId': 'OG001'}]}]}, {'title': 'Mean across all meals (Change from baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.16', 'spread': '1.63', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '1.59', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in mean IG peak after start of meal (breakfast, lunch, main evening meal and mean across all meals) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Time Spent With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'IG ≤2.5 mmol/L (45 mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.11', 'spread': '1.29', 'groupId': 'OG000'}, {'value': '1.03', 'spread': '1.38', 'groupId': 'OG001'}]}]}, {'title': 'IG ≤3.0 mmol/L (54 mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.15', 'spread': '1.98', 'groupId': 'OG000'}, {'value': '2.19', 'spread': '2.25', 'groupId': 'OG001'}]}]}, {'title': 'IG ≤3.5 mmol/L (63 mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.75', 'spread': '2.85', 'groupId': 'OG000'}, {'value': '3.93', 'spread': '3.37', 'groupId': 'OG001'}]}]}, {'title': 'IG ≤3.9 mmol/L (70.2 mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.46', 'spread': '3.68', 'groupId': 'OG000'}, {'value': '5.76', 'spread': '4.25', 'groupId': 'OG001'}]}]}, {'title': 'IG >10.0 mmol/L (180 mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.57', 'spread': '13.09', 'groupId': 'OG000'}, {'value': '39.24', 'spread': '11.86', 'groupId': 'OG001'}]}]}, {'title': 'IG >12.0 mmol/L (216 mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.34', 'spread': '11.66', 'groupId': 'OG000'}, {'value': '24.23', 'spread': '10.75', 'groupId': 'OG001'}]}]}, {'title': 'IG >13.9 mmol/L (250 mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.87', 'spread': '9.42', 'groupId': 'OG000'}, {'value': '14.23', 'spread': '8.49', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 16', 'description': 'Percentage of time spent with IG ≤2.5, 3.0, 3.5, 3.9 mmol/L \\[45, 54, 63, 70 mg/dL\\]) and IG \\>10.0, 12.0, 13.9 mmol/L \\[180, 216, 250 mg/dL\\]) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.', 'unitOfMeasure': '% of time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Incidence of Episodes With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'IG ≤2.5 mmol/L (45 mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1570', 'groupId': 'OG000'}, {'value': '1532', 'groupId': 'OG001'}]}]}, {'title': 'IG ≤3.0 mmol/L (54 mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2848', 'groupId': 'OG000'}, {'value': '2920', 'groupId': 'OG001'}]}]}, {'title': 'IG ≤3.5 mmol/L (63 mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4584', 'groupId': 'OG000'}, {'value': '4742', 'groupId': 'OG001'}]}]}, {'title': 'IG ≤3.9 mmol/L (70 mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6371', 'groupId': 'OG000'}, {'value': '6576', 'groupId': 'OG001'}]}]}, {'title': 'IG >10.0 mmol/L (180 mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35194', 'groupId': 'OG000'}, {'value': '33176', 'groupId': 'OG001'}]}]}, {'title': 'IG >12.0 mmol/L (216 mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23070', 'groupId': 'OG000'}, {'value': '21276', 'groupId': 'OG001'}]}]}, {'title': 'IG >13.9 mmol/L (250 mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14352', 'groupId': 'OG000'}, {'value': '12866', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'Incidence of episodes with IG ≤2.5, 3.0, 3.5, 3.9 mmol/L \\[45, 54, 63, 70 mg/dL\\]) and IG \\>10.0, 12.0, 13.9 mmol/L \\[180, 216, 250 mg/dL\\]) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.', 'unitOfMeasure': 'Number of Events', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean of the IG Profile', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.38', 'spread': '1.18', 'groupId': 'OG000'}, {'value': '9.39', 'spread': '1.20', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.28', 'spread': '1.27', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '1.18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 16', 'description': "Change from baseline (week 0) in mean of the IG profile was evaluated after 16 weeks of randomisation. The mean of an IG profile is defined as the time integral of the profile over the profile's length, divided by the profile's length. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.", 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Time Spent Within IG Target Range 4.0-7.8 mmol/L (71-140 mg/dL) and 4.0-10 mmol/L (71-180 mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'IG 4.0-7.8 mmol/L (71-140 mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.49', 'spread': '9.97', 'groupId': 'OG000'}, {'value': '33.11', 'spread': '8.76', 'groupId': 'OG001'}]}]}, {'title': 'IG 4.0-10.0 mmol/L (71-180 mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52.40', 'spread': '11.87', 'groupId': 'OG000'}, {'value': '54.40', 'spread': '10.70', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 16', 'description': 'Percentage of time spent within IG target range 4.0-7.8 mmol/L (71-140 mg/dL) and 4.0-10 mmol/L (71-180 mg/dL) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.', 'unitOfMeasure': '% of time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Variation in the IG Profile', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.09', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '5.6'}, {'value': '3.04', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '5.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 16', 'description': 'Variation in IG profile was the average absolute difference from the mean of the IG profile. Variation in the IG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve (AUC3.9-IG) for IG ≤3.9 mmol/L [70 mg/dL]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.19', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '3.21', 'spread': '0.20', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 16', 'description': 'Area under the curve (AUC3.9-IG) for IG ≤3.9 mmol/L \\[70 mg/dL\\] was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in AUCIG,0-15min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '228', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.55', 'spread': '2.63', 'groupId': 'OG000'}, {'value': '7.37', 'spread': '2.20', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.16', 'spread': '3.06', 'groupId': 'OG000'}, {'value': '0.21', 'spread': '2.96', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in area under the curve for interstitial glucose (AUCIG),0-15 minutes during meal test was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in AUCIG,0-30min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '228', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.98', 'spread': '2.65', 'groupId': 'OG000'}, {'value': '7.86', 'spread': '2.25', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.12', 'spread': '3.12', 'groupId': 'OG000'}, {'value': '0.22', 'spread': '3.02', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in AUCIG,0-30 minutes during meal test was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in AUCIG,0-1h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '228', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.47', 'spread': '2.76', 'groupId': 'OG000'}, {'value': '9.35', 'spread': '2.38', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.07', 'spread': '3.33', 'groupId': 'OG000'}, {'value': '0.32', 'spread': '3.26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in AUCIG,0-1 hour during meal test was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in AUCIG,0-2h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '228', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.27', 'spread': '3.10', 'groupId': 'OG000'}, {'value': '11.18', 'spread': '2.82', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '206', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.38', 'spread': '3.76', 'groupId': 'OG000'}, {'value': '0.37', 'spread': '3.90', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in AUCIG,0-2 hours during meal test was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in AUCIG,0-4h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.31', 'spread': '3.33', 'groupId': 'OG000'}, {'value': '11.40', 'spread': '3.03', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.32', 'spread': '4.07', 'groupId': 'OG000'}, {'value': '0.29', 'spread': '4.10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in AUCIG,0-24hours during meal test was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Time to the IG Peak After Start of Meal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '111.2', 'spread': '45.3', 'groupId': 'OG000'}, {'value': '117.0', 'spread': '43.0', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.2', 'spread': '50.5', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '51.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in time to the IG peak after start of meal-test meal was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.', 'unitOfMeasure': 'Minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in IG Peak After Start of Meal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.71', 'spread': '3.94', 'groupId': 'OG000'}, {'value': '14.69', 'spread': '3.65', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.57', 'spread': '4.69', 'groupId': 'OG000'}, {'value': '0.36', 'spread': '4.78', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in IG peak after start of meal-test meal was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Treatment Emergent Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '440', 'groupId': 'OG000'}, {'value': '412', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0-16', 'description': 'Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 16. A TEAE was defined as an event that has an onset date on or after the first day of exposure to randomised treatment (in week 0), and no later than seven days after the last day of randomised treatment (i.e., maximum week 16 + 7 days). The results are based on the on-treatment period.', 'unitOfMeasure': 'Number of adverse events', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Treatment Emergent Infusion Site Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0-16', 'description': 'Number of treatment emergent infusion site reactions were recorded from week 0 to week 16. The results are based on the on-treatment period.', 'unitOfMeasure': 'Number of infusion site reaction events', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'ADA: Severe', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Documented symptomatic', 'categories': [{'measurements': [{'value': '8372', 'groupId': 'OG000'}, {'value': '8904', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Asymptomatic', 'categories': [{'measurements': [{'value': '2530', 'groupId': 'OG000'}, {'value': '2273', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Probable symptomatic', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Pseudo', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Unclassifiable', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'NN: BG confirmed', 'categories': [{'measurements': [{'value': '3258', 'groupId': 'OG000'}, {'value': '3240', 'groupId': 'OG001'}]}]}, {'title': 'NN: Severe or BG confirmed symptomatic', 'categories': [{'measurements': [{'value': '2751', 'groupId': 'OG000'}, {'value': '2779', 'groupId': 'OG001'}]}]}, {'title': 'NN: Severe or BG confirmed', 'categories': [{'measurements': [{'value': '3279', 'groupId': 'OG000'}, {'value': '3247', 'groupId': 'OG001'}]}]}, {'title': 'NN: Unclassifiable', 'categories': [{'measurements': [{'value': '7789', 'groupId': 'OG000'}, {'value': '8128', 'groupId': 'OG001'}]}]}, {'title': 'Not able to selftreat - unclassifiable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0-16', 'description': 'ADA classification of hypo:\n\n1. Severe: Requiring assistance of another person to actively administer carbohydrate/glucagon/take other corrective actions. PG levels may not be available during an event, but neurological recovery following return of PG to normal is considered sufficient evidence that event was induced by a low PG level.\n2. Documented symptomatic: PG ≤3.9 mmol/L with symptoms.\n3. Asymptomatic: PG ≤3.9 mmol/L without symptoms.\n4. Probable symptomatic: No measurement with symptoms.\n5. Pseudo: PG \\>3.9 mmol/L with symptoms.\n6. Unclassifiable.\n\nNN classification of hypo:\n\n1. BG confirmed: PG \\<3.1 mmol/L with/without symptoms.\n2. Severe or BG confirmed symptomatic: Severe as per ADA and BG confirmed by PG \\<3.1 mmol/L with symptoms.\n3. Severe or BG confirmed: Severe as per ADA and BG confirmed by PG \\<3.1 mmol/L with/without symptoms.\n4. Unclassifiable.\n\nNot able to self treat-unclassifiable: Not able to self treat but not classifiable as severe hypo.', 'unitOfMeasure': 'Number of hypoglycaemic episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis. The results are based on the on-treatment period.'}, {'type': 'SECONDARY', 'title': 'Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 - Inclusive)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'ADA: Severe', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Documented symptomatic', 'categories': [{'measurements': [{'value': '7508', 'groupId': 'OG000'}, {'value': '7889', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Asymptomatic', 'categories': [{'measurements': [{'value': '2321', 'groupId': 'OG000'}, {'value': '2071', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Probable symptomatic', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Pseudo', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Unclassifiable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'NN: BG confirmed', 'categories': [{'measurements': [{'value': '2799', 'groupId': 'OG000'}, {'value': '2769', 'groupId': 'OG001'}]}]}, {'title': 'NN: Severe or BG confirmed symptomatic', 'categories': [{'measurements': [{'value': '2335', 'groupId': 'OG000'}, {'value': '2359', 'groupId': 'OG001'}]}]}, {'title': 'NN: Severe or BG confirmed', 'categories': [{'measurements': [{'value': '2811', 'groupId': 'OG000'}, {'value': '2774', 'groupId': 'OG001'}]}]}, {'title': 'NN: Unclassifiable', 'categories': [{'measurements': [{'value': '7152', 'groupId': 'OG000'}, {'value': '7361', 'groupId': 'OG001'}]}]}, {'title': 'Not able to selftreat - unclassifiable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0-16', 'description': 'Number of treatment emergent day time hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 06:00 and 00:00 (both included). The results are based on the on-treatment period.', 'unitOfMeasure': 'Number of hypoglycaemic episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'ADA: Severe', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Documented symptomatic', 'categories': [{'measurements': [{'value': '864', 'groupId': 'OG000'}, {'value': '1015', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Asymptomatic', 'categories': [{'measurements': [{'value': '209', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Probable symptomatic', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Pseudo', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Unclassifiable', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'NN: BG confirmed', 'categories': [{'measurements': [{'value': '459', 'groupId': 'OG000'}, {'value': '471', 'groupId': 'OG001'}]}]}, {'title': 'NN: Severe or BG confirmed symptomatic', 'categories': [{'measurements': [{'value': '416', 'groupId': 'OG000'}, {'value': '420', 'groupId': 'OG001'}]}]}, {'title': 'NN: Severe or BG confirmed', 'categories': [{'measurements': [{'value': '468', 'groupId': 'OG000'}, {'value': '473', 'groupId': 'OG001'}]}]}, {'title': 'NN: Unclassifiable', 'categories': [{'measurements': [{'value': '637', 'groupId': 'OG000'}, {'value': '767', 'groupId': 'OG001'}]}]}, {'title': 'Not able to selftreat - unclassifiable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0-16', 'description': 'Number of treatment emergent nocturnal hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 00:01 and 05:59 (both included). The results are based on the on-treatment period.', 'unitOfMeasure': 'Number of hypoglycaemic episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes During First 1 Hour After Start of the Meal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'ADA: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Documented symptomatic', 'categories': [{'measurements': [{'value': '224', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Asymptomatic', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Probable symptomatic', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Pseudo', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Unclassifiable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'NN: BG confirmed', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'NN: Severe or BG confirmed symptomatic', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'NN: Severe or BG confirmed', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'NN: Unclassifiable', 'categories': [{'measurements': [{'value': '164', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}]}]}, {'title': 'Not able to selftreat - unclassifiable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0-16', 'description': 'Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated during the first 1 hour after start of the meal. The results are based on the on-treatment period.', 'unitOfMeasure': 'Number of hypoglycaemic episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 2 Hours After Start of the Meal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'ADA: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Documented symptomatic', 'categories': [{'measurements': [{'value': '1258', 'groupId': 'OG000'}, {'value': '1077', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Asymptomatic', 'categories': [{'measurements': [{'value': '176', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Probable symptomatic', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Pseudo', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Unclassifiable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'NN: BG confirmed', 'categories': [{'measurements': [{'value': '482', 'groupId': 'OG000'}, {'value': '413', 'groupId': 'OG001'}]}]}, {'title': 'NN: Severe or BG confirmed symptomatic', 'categories': [{'measurements': [{'value': '441', 'groupId': 'OG000'}, {'value': '372', 'groupId': 'OG001'}]}]}, {'title': 'NN: Severe or BG confirmed', 'categories': [{'measurements': [{'value': '482', 'groupId': 'OG000'}, {'value': '413', 'groupId': 'OG001'}]}]}, {'title': 'NN: Unclassifiable', 'categories': [{'measurements': [{'value': '968', 'groupId': 'OG000'}, {'value': '879', 'groupId': 'OG001'}]}]}, {'title': 'Not able to selftreat - unclassifiable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0-16', 'description': 'Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated during the first 2 hours after start of the meal. The results are based on the on-treatment period.', 'unitOfMeasure': 'Number of hypoglycaemic episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 4 Hours After Start of the Meal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'ADA: Severe', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Documented symptomatic', 'categories': [{'measurements': [{'value': '3767', 'groupId': 'OG000'}, {'value': '3907', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Asymptomatic', 'categories': [{'measurements': [{'value': '750', 'groupId': 'OG000'}, {'value': '677', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Probable symptomatic', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Pseudo', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Unclassifiable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'NN: BG confirmed', 'categories': [{'measurements': [{'value': '1403', 'groupId': 'OG000'}, {'value': '1399', 'groupId': 'OG001'}]}]}, {'title': 'NN: Severe or BG confirmed symptomatic', 'categories': [{'measurements': [{'value': '1246', 'groupId': 'OG000'}, {'value': '1259', 'groupId': 'OG001'}]}]}, {'title': 'NN: Severe or BG confirmed', 'categories': [{'measurements': [{'value': '1408', 'groupId': 'OG000'}, {'value': '1401', 'groupId': 'OG001'}]}]}, {'title': 'NN: Unclassifiable', 'categories': [{'measurements': [{'value': '3186', 'groupId': 'OG000'}, {'value': '3300', 'groupId': 'OG001'}]}]}, {'title': 'Not able to selftreat - unclassifiable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0-16', 'description': 'Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated during the first 4 hours after start of the meal. The results are based on the on-treatment period.', 'unitOfMeasure': 'Number of hypoglycaemic episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 2 to 4 Hours After Start of the Meal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'ADA: Severe', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Documented symptomatic', 'categories': [{'measurements': [{'value': '2509', 'groupId': 'OG000'}, {'value': '2830', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Asymptomatic', 'categories': [{'measurements': [{'value': '574', 'groupId': 'OG000'}, {'value': '502', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Probable symptomatic', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Pseudo', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Unclassifiable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'NN: BG confirmed', 'categories': [{'measurements': [{'value': '921', 'groupId': 'OG000'}, {'value': '986', 'groupId': 'OG001'}]}]}, {'title': 'NN: Severe or BG confirmed symptomatic', 'categories': [{'measurements': [{'value': '805', 'groupId': 'OG000'}, {'value': '887', 'groupId': 'OG001'}]}]}, {'title': 'NN: Severe or BG confirmed', 'categories': [{'measurements': [{'value': '926', 'groupId': 'OG000'}, {'value': '988', 'groupId': 'OG001'}]}]}, {'title': 'NN: Unclassifiable', 'categories': [{'measurements': [{'value': '2218', 'groupId': 'OG000'}, {'value': '2421', 'groupId': 'OG001'}]}]}, {'title': 'Not able to selftreat - unclassifiable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0-16', 'description': 'Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 2 to 4 hours after start of the meal. The results are based on the on-treatment period.', 'unitOfMeasure': 'Number of hypoglycaemic episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 1 Hour to 2 Hours After Start of the Meal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'ADA: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Documented symptomatic', 'categories': [{'measurements': [{'value': '1034', 'groupId': 'OG000'}, {'value': '887', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Asymptomatic', 'categories': [{'measurements': [{'value': '145', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Probable symptomatic', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Pseudo', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Unclassifiable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'NN: BG confirmed', 'categories': [{'measurements': [{'value': '390', 'groupId': 'OG000'}, {'value': '362', 'groupId': 'OG001'}]}]}, {'title': 'NN: Severe or BG confirmed symptomatic', 'categories': [{'measurements': [{'value': '360', 'groupId': 'OG000'}, {'value': '324', 'groupId': 'OG001'}]}]}, {'title': 'NN: Severe or BG confirmed', 'categories': [{'measurements': [{'value': '390', 'groupId': 'OG000'}, {'value': '362', 'groupId': 'OG001'}]}]}, {'title': 'NN: Unclassifiable', 'categories': [{'measurements': [{'value': '804', 'groupId': 'OG000'}, {'value': '699', 'groupId': 'OG001'}]}]}, {'title': 'Not able to selftreat - unclassifiable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0-16', 'description': 'Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 1 hour to 2 hours after start of the meal. The results are based on the on-treatment period.', 'unitOfMeasure': 'Number of hypoglycaemic episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 2 to 3 Hours After Start of the Meal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'ADA: Severe', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Documented symptomatic', 'categories': [{'measurements': [{'value': '1327', 'groupId': 'OG000'}, {'value': '1518', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Asymptomatic', 'categories': [{'measurements': [{'value': '277', 'groupId': 'OG000'}, {'value': '241', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Probable symptomatic', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Pseudo', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Unclassifiable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'NN: BG confirmed', 'categories': [{'measurements': [{'value': '491', 'groupId': 'OG000'}, {'value': '555', 'groupId': 'OG001'}]}]}, {'title': 'NN: Severe or BG confirmed symptomatic', 'categories': [{'measurements': [{'value': '429', 'groupId': 'OG000'}, {'value': '508', 'groupId': 'OG001'}]}]}, {'title': 'NN: Severe or BG confirmed', 'categories': [{'measurements': [{'value': '493', 'groupId': 'OG000'}, {'value': '556', 'groupId': 'OG001'}]}]}, {'title': 'NN: Unclassifiable', 'categories': [{'measurements': [{'value': '1145', 'groupId': 'OG000'}, {'value': '1249', 'groupId': 'OG001'}]}]}, {'title': 'Not able to selftreat - unclassifiable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0-16', 'description': 'Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 2 to 3 hours after start of the meal. The results are based on the on-treatment period.', 'unitOfMeasure': 'Number of hypoglycaemic episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 3 to 4 Hours After Start of the Meal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'ADA: Severe', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Documented symptomatic', 'categories': [{'measurements': [{'value': '1182', 'groupId': 'OG000'}, {'value': '1312', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Asymptomatic', 'categories': [{'measurements': [{'value': '297', 'groupId': 'OG000'}, {'value': '261', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Probable symptomatic', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Pseudo', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Unclassifiable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'NN: BG confirmed', 'categories': [{'measurements': [{'value': '430', 'groupId': 'OG000'}, {'value': '431', 'groupId': 'OG001'}]}]}, {'title': 'NN: Severe or BG confirmed symptomatic', 'categories': [{'measurements': [{'value': '376', 'groupId': 'OG000'}, {'value': '379', 'groupId': 'OG001'}]}]}, {'title': 'NN: Severe or BG confirmed', 'categories': [{'measurements': [{'value': '433', 'groupId': 'OG000'}, {'value': '432', 'groupId': 'OG001'}]}]}, {'title': 'NN: Unclassifiable', 'categories': [{'measurements': [{'value': '1073', 'groupId': 'OG000'}, {'value': '1172', 'groupId': 'OG001'}]}]}, {'title': 'Not able to selftreat - unclassifiable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0-16', 'description': 'Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 3 to 4 hours after start of the meal. The results are based on the on-treatment period.', 'unitOfMeasure': 'Number of hypoglycaemic episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Unexplained Episodes of Hyperglycaemia (Confirmed by SMPG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '1185', 'groupId': 'OG000'}, {'value': '1058', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0-16', 'description': 'Unexplained hyperglycaemia was defined as a confirmed PG value ≥16.7 mmol/L (300 mg/dL) and was unexplained (i.e. no apparent medical, dietary, insulin dosage or pump failure reason). The results are based on the on-treatment period.', 'unitOfMeasure': 'Number of hypoglycaemic episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Physical Examination: Respiratory System', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'Normal, baseline', 'categories': [{'measurements': [{'value': '234', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}]}]}, {'title': 'Abnormal (NCS), baseline', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Abnormal (CS), baseline', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Normal, last on-treatment value', 'categories': [{'measurements': [{'value': '235', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}]}, {'title': 'Abnormal (NCS), last on-treatment value', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Abnormal (CS), last on-treatment value', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0, week 16', 'description': 'Reported results are respiratory system-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant \\[NCS\\]). 3) Abnormal (clinically significant \\[CS\\]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.', 'unitOfMeasure': 'Number of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Physical Examination: Cardiovascular System', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'Normal, baseline', 'categories': [{'measurements': [{'value': '233', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}]}, {'title': 'Abnormal (NCS), baseline', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Abnormal (CS), baseline', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Normal, last on-treatment value', 'categories': [{'measurements': [{'value': '231', 'groupId': 'OG000'}, {'value': '228', 'groupId': 'OG001'}]}]}, {'title': 'Abnormal (NCS), last on-treatment value', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Abnormal (CS), last on-treatment value', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0, week 16', 'description': 'Reported results are cardiovascular system-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant \\[NCS\\]). 3) Abnormal (clinically significant \\[CS\\]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.', 'unitOfMeasure': 'Number of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Physical Examination: Central and Peripheral Nervous System', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'Normal, baseline', 'categories': [{'measurements': [{'value': '210', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}]}, {'title': 'Abnormal (NCS), baseline', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Abnormal (CS), baseline', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Normal, last on-treatment value', 'categories': [{'measurements': [{'value': '209', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}]}, {'title': 'Abnormal (NCS), last on-treatment value', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Abnormal (CS), last on-treatment value', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0, week 16', 'description': 'Reported results are central and peripheral nervous system-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant \\[NCS\\]). 3) Abnormal (clinically significant \\[CS\\]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.', 'unitOfMeasure': 'Number of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Physical Examination: Gastrointestinal System, Including the Mouth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'Normal, baseline', 'categories': [{'measurements': [{'value': '231', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}]}, {'title': 'Abnormal (NCS), baseline', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Abnormal (CS), baseline', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Normal, last on-treatment value', 'categories': [{'measurements': [{'value': '231', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}]}, {'title': 'Abnormal (NCS), last on-treatment value', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Abnormal (CS), last on-treatment value', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0, week 16', 'description': 'Reported results are gastrointestinal system-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant \\[NCS\\]). 3) Abnormal (clinically significant \\[CS\\]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.', 'unitOfMeasure': 'Number of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Physical Examination: Musculoskeletal System', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'Normal, baseline', 'categories': [{'measurements': [{'value': '222', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}]}]}, {'title': 'Abnormal (NCS), baseline', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Abnormal (CS), baseline', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Normal, last on-treatment value', 'categories': [{'measurements': [{'value': '223', 'groupId': 'OG000'}, {'value': '228', 'groupId': 'OG001'}]}]}, {'title': 'Abnormal (NCS), last on-treatment value', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Abnormal (CS), last on-treatment value', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0, week 16', 'description': 'Reported results are musculoskeletal system-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant \\[NCS\\]). 3) Abnormal (clinically significant \\[CS\\]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.', 'unitOfMeasure': 'Number of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Physical Examination: Skin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'Normal, baseline', 'categories': [{'measurements': [{'value': '212', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}]}]}, {'title': 'Abnormal (NCS), baseline', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Abnormal (CS), baseline', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Normal, last on-treatment value', 'categories': [{'measurements': [{'value': '204', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}]}, {'title': 'Abnormal (NCS), last on-treatment value', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Abnormal (CS), last on-treatment value', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0, week 16', 'description': 'Reported results are skin-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant \\[NCS\\]). 3) Abnormal (clinically significant \\[CS\\]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.', 'unitOfMeasure': 'Number of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Physical Examination: Head, Ears, Eyes, Nose, Throat and Neck', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'Normal, baseline', 'categories': [{'measurements': [{'value': '219', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}]}, {'title': 'Abnormal (NCS), baseline', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Abnormal (CS), baseline', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Normal, last on-treatment value', 'categories': [{'measurements': [{'value': '217', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}]}, {'title': 'Abnormal (NCS), last on-treatment value', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Abnormal (CS), last on-treatment value', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0, week 16', 'description': 'Reported results are head, ears, eyes, nose, throat and neck-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant \\[NCS\\]). 3) Abnormal (clinically significant \\[CS\\]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.', 'unitOfMeasure': 'Number of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Vital Sign: Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'Systolic blood pressure (baseline)', 'categories': [{'measurements': [{'value': '123.6', 'spread': '14.7', 'groupId': 'OG000'}, {'value': '122.0', 'spread': '14.3', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic blood pressure (baseline)', 'categories': [{'measurements': [{'value': '74.8', 'spread': '9.4', 'groupId': 'OG000'}, {'value': '74.6', 'spread': '8.7', 'groupId': 'OG001'}]}]}, {'title': 'Systolic blood pressure (change from baseline)', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '12.3', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '11.5', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic blood pressure (change from baseline)', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '8.4', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '7.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in blood pressure (both systolic and diastolic) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Vital Sign: Pulse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '73.7', 'spread': '11.0', 'groupId': 'OG000'}, {'value': '74.5', 'spread': '11.1', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '9.0', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '9.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in pulse was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.', 'unitOfMeasure': 'Beats/minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Screening in Electrocardiogram (ECG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'Normal, screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '178', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}]}, {'title': 'Abnormal (NCS), screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'Abnormal (CS), screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Normal, last on-treatment value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '188', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}]}]}, {'title': 'Abnormal (NCS), last on-treatment value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'Abnormal (CS), last on-treatment value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0, week 16', 'description': 'Reported results are ECG findings at screening (week -6) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant \\[NCS\\]). 3) Abnormal (clinically significant \\[CS\\]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.', 'unitOfMeasure': 'Number of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Screening in Fundus Photography/Fundoscopy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'Left eye (Normal), screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '135', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}]}, {'title': 'Left eye (Abnormal [NCS]), screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}]}, {'title': 'Left eye (Abnormal [CS]), screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Right eye (Normal), screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '132', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}]}, {'title': 'Right eye (Abnormal [NCS]), screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}]}, {'title': 'Right eye (Abnormal [CS]), screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Left eye (Normal), last on-treatment value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '130', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}]}, {'title': 'Left eye (Abnormal [NCS]), last on-treatment value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}]}, {'title': 'Left eye (Abnormal [CS] last on-treatment value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Right eye (Normal), last on-treatment value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '127', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}]}, {'title': 'Right eye (Abnormal-NCS), last on-treatment value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}]}, {'title': 'Right eye (Abnormal [CS]), last on-treatment value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0, week 16', 'description': 'Reported results are fundus photography/fundoscopy (for both left and right eye) findings at screening (week -6) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) AAbnormal (not clinically significant \\[NCS\\]). 3) Abnormal (clinically significant \\[CS\\]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.', 'unitOfMeasure': 'Number of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Haematology: Haemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '8.62', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '8.62', 'spread': '0.80', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline', 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '0.40', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in haemoglobin was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Haematology: Haematocrit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '42.23', 'spread': '3.98', 'groupId': 'OG000'}, {'value': '42.37', 'spread': '3.77', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline', 'categories': [{'measurements': [{'value': '0.09', 'spread': '2.47', 'groupId': 'OG000'}, {'value': '-0.30', 'spread': '2.01', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in haematocrit was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.', 'unitOfMeasure': '% of haematocrit', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Haematology: Erythrocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.66', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '4.72', 'spread': '0.42', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline', 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.22', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in erythrocytes was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.', 'unitOfMeasure': '10^12/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Haematology: Thrombocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '246.4', 'spread': '58.9', 'groupId': 'OG000'}, {'value': '243.6', 'spread': '55.3', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline', 'categories': [{'measurements': [{'value': '2.2', 'spread': '33.5', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '35.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in thrombocytes was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.', 'unitOfMeasure': '10^9/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Haematology: Leucocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '6.41', 'spread': '1.78', 'groupId': 'OG000'}, {'value': '6.32', 'spread': '1.70', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline', 'categories': [{'measurements': [{'value': '-0.09', 'spread': '1.49', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '1.22', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in leucocytes was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.', 'unitOfMeasure': '10^9/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Biochemistry: Total Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '6.73', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '6.74', 'spread': '0.47', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline', 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.36', 'groupId': 'OG000'}, {'value': '-0.05', 'spread': '0.40', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in total protein was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Biochemistry: Creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '73.8', 'spread': '12.3', 'groupId': 'OG000'}, {'value': '74.5', 'spread': '13.3', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline', 'categories': [{'measurements': [{'value': '0.9', 'spread': '7.9', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '8.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in creatinine was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.', 'unitOfMeasure': 'umol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Biochemistry: Alanine Aminotransferase (ALT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '20.0', 'spread': '11.6', 'groupId': 'OG000'}, {'value': '19.1', 'spread': '11.5', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline', 'categories': [{'measurements': [{'value': '0.1', 'spread': '13.8', 'groupId': 'OG000'}, {'value': '0', 'spread': '9.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in ALT was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Biochemistry: Aspartate Aminotransferase (AST)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '22.2', 'spread': '9.1', 'groupId': 'OG000'}, {'value': '20.6', 'spread': '7.8', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '18.6', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '8.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in AST was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Biochemistry: Alkaline Phosphatase (ALP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '68.8', 'spread': '20.8', 'groupId': 'OG000'}, {'value': '69.7', 'spread': '23.9', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline', 'categories': [{'measurements': [{'value': '1.2', 'spread': '9.6', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '10.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in ALP was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Biochemistry: Sodium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '140.3', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '140.3', 'spread': '2.7', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '2.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in sodium was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Biochemistry: Potassium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.34', 'spread': '0.42', 'groupId': 'OG000'}, {'value': '4.30', 'spread': '0.39', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline', 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.42', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.41', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in potassium was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Biochemistry: Albumin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.32', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '4.31', 'spread': '0.28', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline', 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '-0.05', 'spread': '0.26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in albumin was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Biochemistry: Total Bilirubin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '8.2', 'spread': '5.1', 'groupId': 'OG000'}, {'value': '8.8', 'spread': '6.4', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '3.8', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '3.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in bilirubin was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.', 'unitOfMeasure': 'umol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Urinalysis: Albumin/Creatine Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.67', 'spread': '13.88', 'groupId': 'OG000'}, {'value': '2.00', 'spread': '7.60', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline', 'categories': [{'measurements': [{'value': '0.01', 'spread': '4.76', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '3.11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in albumin/creatine ratio was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.', 'unitOfMeasure': 'mg/mmol', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Urinalysis: Erythrocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'Negative (baseline)', 'categories': [{'measurements': [{'value': '217', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}]}, {'title': 'Trace (baseline)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': '1+ (baseline)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': '2+ (baseline)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '3+ (baseline)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Negative (last on-treatment value)', 'categories': [{'measurements': [{'value': '217', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}]}, {'title': 'Trace (last on-treatment value)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': '1+ (last on-treatment value)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': '2+ (last on-treatment value)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': '3+ (last on-treatment value)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0, week 16', 'description': 'Reported results are urine erythrocytes-test findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: a) Negative, b) Trace, c) 1+, d) 2+ and e) 3+. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.', 'unitOfMeasure': 'Number of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Urinalysis: Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'Negative (baseline)', 'categories': [{'measurements': [{'value': '193', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}]}, {'title': 'Trace (baseline)', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': '1+ (baseline)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': '2+ (baseline)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': '3+ (baseline)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '4+ (baseline)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Negative (last on-treatment value)', 'categories': [{'measurements': [{'value': '196', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}]}, {'title': 'Trace (last on-treatment value)', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': '1+ (last on-treatment value)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': '2+ (last on-treatment value)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': '3+ (last on-treatment value)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '4+ (last on-treatment value)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0, week 16', 'description': 'Reported results are urine protein-test findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: a) Negative, b) Trace, c) 1+, d) 2+ e) 3+ and f) 4+. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.', 'unitOfMeasure': 'Number of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Urinalysis: Ketones', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'Negative (baseline)', 'categories': [{'measurements': [{'value': '192', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}]}, {'title': 'Trace (baseline)', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': '1+ (baseline)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': '2+ (baseline)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '3+ (baseline)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '4+ (baseline)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Negative (last on-treatment value)', 'categories': [{'measurements': [{'value': '194', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}]}, {'title': 'Trace (last on-treatment value)', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': '1+ (last on-treatment value)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': '2+ (last on-treatment value)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '3+ (last on-treatment value)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '4+ (last on-treatment value)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0, week 16', 'description': 'Reported results are urine ketone-test findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: a) Negative, b) Trace, c) 1+, d) 2+ e) 3+ and f) 4+. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.', 'unitOfMeasure': 'Number of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '76.86', 'spread': '15.20', 'groupId': 'OG000'}, {'value': '78.21', 'spread': '14.47', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline', 'categories': [{'measurements': [{'value': '0.34', 'spread': '1.90', 'groupId': 'OG000'}, {'value': '0.80', 'spread': '2.14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in body weight was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.', 'unitOfMeasure': 'Kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Mass Index (BMI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '26.16', 'spread': '4.06', 'groupId': 'OG000'}, {'value': '26.51', 'spread': '3.89', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline', 'categories': [{'measurements': [{'value': '0.12', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '0.28', 'spread': '0.74', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in BMI was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Change-of-infusion-sets Per Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.55', 'spread': '0.43', 'groupId': 'OG000'}, {'value': '2.49', 'spread': '0.47', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0-16', 'description': 'Number of change-of-infusion-sets per week was evaluated from week 0 to week 16. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.', 'unitOfMeasure': 'Number of infusion-sets', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With at Least One Non-routine Change-of-infusion-sets Categorised by Reasons for Change-of-infusion-sets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'classes': [{'title': 'Category-1', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}, {'title': 'Category-2', 'categories': [{'measurements': [{'value': '108', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}]}, {'title': 'Category-3', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Category-4', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Category-5', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}, {'title': 'Category-6', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Category-7', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0-16', 'description': 'Number of subjects with at least one non-routine change-of-infusion-sets categorised by reasons for change-of-infusion-sets was evaluated from week 0 to week 16. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.\n\nReasons for change-of-infusion-sets are categorised as follows:\n\nCategory-1: A perceived occlusion by the subject Category-2: Any problems related to the infusion set Category-3: Any technical issues with the pump Category-4: Changes in the insulin solution in the infusion set or reservoir Category-5: High BG with no other explanation which made the subject change the infusion set Category-6: Infusion site reaction Category-7: Missing', 'unitOfMeasure': 'Number of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by continuous subcutaneous insulin infusion (CSII) for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that blood glucose (BG) was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'FG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '236'}, {'groupId': 'FG001', 'numSubjects': '236'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '233'}, {'groupId': 'FG001', 'numSubjects': '230'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Unclassified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "The trial was conducted at 92 sites in 9 countries.as follows: Belgium (7), Canada (8), France (10), Germany (9), Netherlands (9), Russian Federation (11), Slovenia (2), United Kingdom (6), and United States (30). One (1) site in the Netherlands screened, but didn't randomise any subject.", 'preAssignmentDetails': 'There was a 4-week run-in period primarily for reinforcement of subject training in trial procedures, diabetes education and collecting baseline assessments. Subjects remained on their pre-trial insulin treatment during the run-in period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'BG000'}, {'value': '236', 'groupId': 'BG001'}, {'value': '472', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Faster Aspart', 'description': 'The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'BG001', 'title': 'NovoRapid', 'description': 'The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \\[71-108 mg/dL\\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.3', 'spread': '14.8', 'groupId': 'BG000'}, {'value': '43.6', 'spread': '14.7', 'groupId': 'BG001'}, {'value': '43.5', 'spread': '14.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The full analysis (FAS) included all randomised subjects.'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '133', 'groupId': 'BG000'}, {'value': '136', 'groupId': 'BG001'}, {'value': '269', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '203', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The FAS included all randomised subjects.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '210', 'groupId': 'BG000'}, {'value': '215', 'groupId': 'BG001'}, {'value': '425', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The FAS included all randomised subjects.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '209', 'groupId': 'BG000'}, {'value': '210', 'groupId': 'BG001'}, {'value': '419', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The FAS included all randomised subjects.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-08', 'size': 1354749, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-06-27T04:46', 'hasProtocol': True}, {'date': '2018-02-08', 'size': 547184, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-06-27T04:46', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 472}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-12', 'studyFirstSubmitDate': '2016-07-04', 'resultsFirstSubmitDate': '2018-06-27', 'studyFirstSubmitQcDate': '2016-07-04', 'lastUpdatePostDateStruct': {'date': '2019-11-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-06-27', 'studyFirstPostDateStruct': {'date': '2016-07-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Glycosylated Haemoglobin (HbA1c)', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in HbA1c was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In-trial period: the observation period from date of randomisation until last trial-related subject-site contact.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in 1-hour PPG Increment', 'timeFrame': 'Week 0, Week 16', 'description': 'Change from baseline (week 0) in 1-hour postprandial glucose (PPG) increment was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.'}, {'measure': 'Change From Baseline in 1,5-anhydroglucitol', 'timeFrame': 'Week 0, Week 16', 'description': 'Change from baseline (week 0) in 1,5-anhydroglucitol was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.'}, {'measure': 'Change From Baseline in Time Spent in Low IG (≤3.9 mmol/L [70 mg/dL]) During CGM', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in low interstitial glucose (IG) (≤3.9 mmol/L \\[70 mg/dL\\]) during continuous glucose monitoring (CGM) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose (FPG)', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in FPG was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.'}, {'measure': 'Percentage of Subjects Reaching HbA1c <7.0% (53 mmol/Mol)', 'timeFrame': 'Week 16', 'description': 'Percentage of subjects reaching HbA1c \\<7.0% (53 mmol/mol) was evaluated after 16 weeks of randomisation. Subjects without an HbA1c measurement at week 16 were considered not to have achieved HbA1c target at week 16. The results are based on the in-trial period.'}, {'measure': 'Percentage of Subjects Reaching HbA1c <7.0% (53 mmol/Mol) Without Severe Hypoglycaemic Episodes', 'timeFrame': 'Week 16', 'description': 'Percentage of subjects reaching HbA1c \\<7.0% (53 mmol/mol) without treatment emergent severe hypoglycaemic episodes was evaluated after 16 weeks of randomisation. Subjects without an HbA1c measurement at week 16 were considered not to have achieved HbA1c target at week 16. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose (PG) concentrations may not be available during an event, but neurological recovery following the return of PG to normal was considered sufficient evidence that the event was induced by a low PG concentration. Treatment emergent: hypoglycaemic episodes were defined as treatment emergent if the onset of the episode occurred on or after the first day of IMP administration after randomisation (in week 0) and no later than one day after the last day on IMP (i.e., maximum week 16 + 1 day). The results are based on the in-trial period.'}, {'measure': 'Change From Baseline in 30-min, 1-hour, 2-hour, 3-hour and 4-hour PPG (Meal Test)', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour postprandial glucose (PPG \\[meal test\\]) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. Meal test: The subjects were given a carbohydrate-rich standardised liquid meal immediately after bolus (faster aspart or NovoRapid®) infusion in the morning of the meal test. The subjects were to consume the meal as quickly as possible (within 12 minutes) and blood samples were drawn after 30 minutes, 1, 2, 3 and 4 hours from the start of the meal.'}, {'measure': 'Change From Baseline in 30-min, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test)', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in 30-min, 2-hour, 3-hour and 4-hour PPG increment (meal test) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. Meal test: The subjects were given a carbohydrate-rich standardised liquid meal immediately after bolus (faster aspart or NovoRapid®) infusion in the morning of the meal test. The subjects were to consume the meal as quickly as possible (within 12 minutes) and PPG was evaluated after 30 minutes, 1, 2, 3 and 4 hours from the start of the meal.'}, {'measure': 'Change From Baseline in Mean of the 7-7-9 Point Self-measured Plasma Glucose (SMPG) Profile', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in mean of the 7-7-9 point SMPG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. 7-7-9 point SMPG was measured at the following mentioned time points: 1) Before breakfast, 2) 60 mins after the start of Breakfast, 3) Before lunch, 4) 60 mins after the start of lunch, 5) Before main evening meal, 6) 60 mins after the start of main evening meal, 7) At bedtime, 8) At 4 AM, 9) Before breakfast.'}, {'measure': 'Change From Baseline of the 7-7-9 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal)', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in PPG (breakfast, lunch, main evening meal and mean over all meals) of the 7-7-9 point SMPG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.'}, {'measure': 'Change From Baseline of the 7-7-9 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal)', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in PPG increment (breakfast, lunch, main evening meal and mean over all meals) of the 7-7-9 point SMPG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.'}, {'measure': 'Change From Baseline of the 7-7-9 Point SMPG Profile: Pre-prandial Plasma Glucose (PG) (Mean, Pre-breakfast, Pre-lunch, Pre-main Evening Meal)', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in pre-prandial PG (pre-breakfast, pre-lunch, pre-main evening meal and mean over all meals) of the 7-7-9 point SMPG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.'}, {'measure': 'Change From Baseline of the 7-7-9 Point SMPG Profile: Fluctuation in 7-7-9 Point Profile', 'timeFrame': 'Week 0, week 16', 'description': 'Fluctuation in 7-point SMPG profile was the average absolute difference from the mean of the SMPG profile. Reported results are fluctuation in the 7-7-9 point SMPG profile at baseline (week 0) and after 16 weeks of randomisation (i.e., week 16). The results are based on the last in-trial value, which included the last available measurement in the in-trial period.'}, {'measure': 'Change From Baseline of the 7-7-9 Point SMPG Profile: in Nocturnal SMPG Measurements', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in nocturnal SMPG measurements was assessed by considering the differences between PG values available at bedtime, at 4 AM and the before breakfast value the following day: (4 AM PG value minus at bedtime PG value), (before breakfast PG value minus at bedtime PG value) and (before breakfast PG value minus 4 AM PG value). Change from baseline in nocturnal increments in SMPG measurements of the 7-7-9 point SMPG profile was evaluated after 16 weeks of randomisation and presented during three different time intervals as follows: 1) 04:00 to breakfast, 2) bedtime to 04:00, and 3) bedtime to breakfast. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.'}, {'measure': 'Percentage of Subjects Reaching Overall PPG (1 Hour) ≤7.8 mmol/L [140 mg/dL]', 'timeFrame': 'Week 16', 'description': 'Percentage of subjects reaching overall PPG (1 hour) ≤7.8 mmol/L \\[140 mg/dL\\] was evaluated after 16 weeks of randomisation. Subjects without a postprandial glucose measurement at week 16 were considered not to have achieved HbA1c target at week 16. The results are based on the in-trial period.'}, {'measure': 'Percentage of Subjects Reaching Overall PPG (1 Hour) ≤7.8 mmol/L [140 mg/dL] Without Severe Hypoglycaemia', 'timeFrame': 'Week 16', 'description': 'Percentage of subjects reaching overall PPG (1 hour) ≤7.8 mmol/L \\[140 mg/dL\\] without treatment emergent severe hypoglycaemia was evaluated after 16 weeks of randomisation. Subjects without a postprandial glucose measurement at week 16 were considered not to have achieved HbA1c target at week 16. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose (PG) concentrations may not be available during an event, but neurological recovery following the return of PG to normal was considered sufficient evidence that the event was induced by a low PG concentration. The results are based on the in-trial period.'}, {'measure': 'Change From Baseline in Lipids-lipoproteins Profile (Total Cholesterol, High Density Lipoproteins, Low Density Lipoproteins)', 'timeFrame': 'Week 0, week 16', 'description': 'Reported results are lipids-lipoproteins (total cholesterol, high density lipoproteins, low density lipoproteins) values at baseline (week 0) and after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.'}, {'measure': 'Insulin Dose in Units/Day: Total Basal', 'timeFrame': 'Week 16', 'description': 'Total basal insulin dose (Units/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period: the observation period from date of first dose of randomised trial products (faster aspart and NovoRapid®) to no later than 7 days after the day of last dose of randomised trial products.'}, {'measure': 'Insulin Dose in Units/Day: Total Bolus', 'timeFrame': 'Week 16', 'description': 'Total bolus insulin dose (Units/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.'}, {'measure': 'Insulin Dose in Units/Day: Total Daily Insulin Dose', 'timeFrame': 'Week 16', 'description': 'Total insulin dose (Units/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.'}, {'measure': 'Insulin Dose in Units/Day: Individual Meal Insulin Dose', 'timeFrame': 'Week 16', 'description': 'No data was collected for individual meal insulin dose.'}, {'measure': 'Insulin Dose in Units/kg/Day: Total Basal', 'timeFrame': 'Week 16', 'description': 'Total basal insulin dose (Units/kg/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.'}, {'measure': 'Insulin Dose in Units/kg/Day: Total Bolus', 'timeFrame': 'Week 16', 'description': 'Total bolus insulin dose (Units/kg/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.'}, {'measure': 'Insulin Dose in Units/kg/Day: Total Daily Insulin Dose', 'timeFrame': 'Week 16', 'description': 'Total insulin dose (Units/kg/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.'}, {'measure': 'Insulin Dose in Units/kg/Day: Individual Meal Insulin Dose', 'timeFrame': 'Week 16', 'description': 'No data was collected for individual meal insulin dose.'}, {'measure': 'Insulin Delivery Pump Parameter: Insulin Carbohydrate Ratio', 'timeFrame': 'Week 16', 'description': 'Insulin carbohydrate ratio was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.'}, {'measure': 'Insulin Delivery Pump Parameter: Glucose Sensitivity Factor', 'timeFrame': 'Week 16', 'description': 'Glucose sensitivity factor was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.'}, {'measure': 'Insulin Delivery Pump Parameter: Active Insulin Time', 'timeFrame': 'Week 16', 'description': 'Active insulin time was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.'}, {'measure': 'Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal)', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in mean interstitial glucose (IG) increment (0-30 minutes (min), 0-1 hour (h) and 0-2 h after start of meal) (breakfast, lunch, main evening meal and mean across all meals) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.'}, {'measure': 'Change From Baseline in Mean Time to the IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal)', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in mean time to the IG peak after start of meal (breakfast, lunch, main evening meal and mean across all meals) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.'}, {'measure': 'Change From Baseline in Mean IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal)', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in mean IG peak after start of meal (breakfast, lunch, main evening meal and mean across all meals) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.'}, {'measure': 'Percentage of Time Spent With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL])', 'timeFrame': 'Week 16', 'description': 'Percentage of time spent with IG ≤2.5, 3.0, 3.5, 3.9 mmol/L \\[45, 54, 63, 70 mg/dL\\]) and IG \\>10.0, 12.0, 13.9 mmol/L \\[180, 216, 250 mg/dL\\]) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.'}, {'measure': 'Incidence of Episodes With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL])', 'timeFrame': 'Week 16', 'description': 'Incidence of episodes with IG ≤2.5, 3.0, 3.5, 3.9 mmol/L \\[45, 54, 63, 70 mg/dL\\]) and IG \\>10.0, 12.0, 13.9 mmol/L \\[180, 216, 250 mg/dL\\]) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.'}, {'measure': 'Change From Baseline in Mean of the IG Profile', 'timeFrame': 'Week 0, week 16', 'description': "Change from baseline (week 0) in mean of the IG profile was evaluated after 16 weeks of randomisation. The mean of an IG profile is defined as the time integral of the profile over the profile's length, divided by the profile's length. The results are based on the last in-trial value, which included the last available measurement in the in-trial period."}, {'measure': 'Percentage of Time Spent Within IG Target Range 4.0-7.8 mmol/L (71-140 mg/dL) and 4.0-10 mmol/L (71-180 mg/dL)', 'timeFrame': 'Week 16', 'description': 'Percentage of time spent within IG target range 4.0-7.8 mmol/L (71-140 mg/dL) and 4.0-10 mmol/L (71-180 mg/dL) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.'}, {'measure': 'Variation in the IG Profile', 'timeFrame': 'Week 16', 'description': 'Variation in IG profile was the average absolute difference from the mean of the IG profile. Variation in the IG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.'}, {'measure': 'Area Under the Curve (AUC3.9-IG) for IG ≤3.9 mmol/L [70 mg/dL]', 'timeFrame': 'Week 16', 'description': 'Area under the curve (AUC3.9-IG) for IG ≤3.9 mmol/L \\[70 mg/dL\\] was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.'}, {'measure': 'Change From Baseline in AUCIG,0-15min', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in area under the curve for interstitial glucose (AUCIG),0-15 minutes during meal test was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.'}, {'measure': 'Change From Baseline in AUCIG,0-30min', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in AUCIG,0-30 minutes during meal test was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.'}, {'measure': 'Change From Baseline in AUCIG,0-1h', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in AUCIG,0-1 hour during meal test was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.'}, {'measure': 'Change From Baseline in AUCIG,0-2h', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in AUCIG,0-2 hours during meal test was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.'}, {'measure': 'Change From Baseline in AUCIG,0-4h', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in AUCIG,0-24hours during meal test was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.'}, {'measure': 'Change From Baseline in Time to the IG Peak After Start of Meal', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in time to the IG peak after start of meal-test meal was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.'}, {'measure': 'Change From Baseline in IG Peak After Start of Meal', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in IG peak after start of meal-test meal was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.'}, {'measure': 'Number of Treatment Emergent Adverse Events (AEs)', 'timeFrame': 'Weeks 0-16', 'description': 'Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 16. A TEAE was defined as an event that has an onset date on or after the first day of exposure to randomised treatment (in week 0), and no later than seven days after the last day of randomised treatment (i.e., maximum week 16 + 7 days). The results are based on the on-treatment period.'}, {'measure': 'Number of Treatment Emergent Infusion Site Reactions', 'timeFrame': 'Weeks 0-16', 'description': 'Number of treatment emergent infusion site reactions were recorded from week 0 to week 16. The results are based on the on-treatment period.'}, {'measure': 'Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall', 'timeFrame': 'Weeks 0-16', 'description': 'ADA classification of hypo:\n\n1. Severe: Requiring assistance of another person to actively administer carbohydrate/glucagon/take other corrective actions. PG levels may not be available during an event, but neurological recovery following return of PG to normal is considered sufficient evidence that event was induced by a low PG level.\n2. Documented symptomatic: PG ≤3.9 mmol/L with symptoms.\n3. Asymptomatic: PG ≤3.9 mmol/L without symptoms.\n4. Probable symptomatic: No measurement with symptoms.\n5. Pseudo: PG \\>3.9 mmol/L with symptoms.\n6. Unclassifiable.\n\nNN classification of hypo:\n\n1. BG confirmed: PG \\<3.1 mmol/L with/without symptoms.\n2. Severe or BG confirmed symptomatic: Severe as per ADA and BG confirmed by PG \\<3.1 mmol/L with symptoms.\n3. Severe or BG confirmed: Severe as per ADA and BG confirmed by PG \\<3.1 mmol/L with/without symptoms.\n4. Unclassifiable.\n\nNot able to self treat-unclassifiable: Not able to self treat but not classifiable as severe hypo.'}, {'measure': 'Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 - Inclusive)', 'timeFrame': 'Weeks 0-16', 'description': 'Number of treatment emergent day time hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 06:00 and 00:00 (both included). The results are based on the on-treatment period.'}, {'measure': 'Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive)', 'timeFrame': 'Weeks 0-16', 'description': 'Number of treatment emergent nocturnal hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 00:01 and 05:59 (both included). The results are based on the on-treatment period.'}, {'measure': 'Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes During First 1 Hour After Start of the Meal', 'timeFrame': 'Weeks 0-16', 'description': 'Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated during the first 1 hour after start of the meal. The results are based on the on-treatment period.'}, {'measure': 'Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 2 Hours After Start of the Meal', 'timeFrame': 'Weeks 0-16', 'description': 'Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated during the first 2 hours after start of the meal. The results are based on the on-treatment period.'}, {'measure': 'Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 4 Hours After Start of the Meal', 'timeFrame': 'Weeks 0-16', 'description': 'Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated during the first 4 hours after start of the meal. The results are based on the on-treatment period.'}, {'measure': 'Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 2 to 4 Hours After Start of the Meal', 'timeFrame': 'Weeks 0-16', 'description': 'Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 2 to 4 hours after start of the meal. The results are based on the on-treatment period.'}, {'measure': 'Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 1 Hour to 2 Hours After Start of the Meal', 'timeFrame': 'Weeks 0-16', 'description': 'Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 1 hour to 2 hours after start of the meal. The results are based on the on-treatment period.'}, {'measure': 'Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 2 to 3 Hours After Start of the Meal', 'timeFrame': 'Weeks 0-16', 'description': 'Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 2 to 3 hours after start of the meal. The results are based on the on-treatment period.'}, {'measure': 'Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 3 to 4 Hours After Start of the Meal', 'timeFrame': 'Weeks 0-16', 'description': 'Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 3 to 4 hours after start of the meal. The results are based on the on-treatment period.'}, {'measure': 'Number of Unexplained Episodes of Hyperglycaemia (Confirmed by SMPG)', 'timeFrame': 'Weeks 0-16', 'description': 'Unexplained hyperglycaemia was defined as a confirmed PG value ≥16.7 mmol/L (300 mg/dL) and was unexplained (i.e. no apparent medical, dietary, insulin dosage or pump failure reason). The results are based on the on-treatment period.'}, {'measure': 'Change From Baseline in Physical Examination: Respiratory System', 'timeFrame': 'Week 0, week 16', 'description': 'Reported results are respiratory system-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant \\[NCS\\]). 3) Abnormal (clinically significant \\[CS\\]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.'}, {'measure': 'Change From Baseline in Physical Examination: Cardiovascular System', 'timeFrame': 'Week 0, week 16', 'description': 'Reported results are cardiovascular system-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant \\[NCS\\]). 3) Abnormal (clinically significant \\[CS\\]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.'}, {'measure': 'Change From Baseline in Physical Examination: Central and Peripheral Nervous System', 'timeFrame': 'Week 0, week 16', 'description': 'Reported results are central and peripheral nervous system-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant \\[NCS\\]). 3) Abnormal (clinically significant \\[CS\\]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.'}, {'measure': 'Change From Baseline in Physical Examination: Gastrointestinal System, Including the Mouth', 'timeFrame': 'Week 0, week 16', 'description': 'Reported results are gastrointestinal system-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant \\[NCS\\]). 3) Abnormal (clinically significant \\[CS\\]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.'}, {'measure': 'Change From Baseline in Physical Examination: Musculoskeletal System', 'timeFrame': 'Week 0, week 16', 'description': 'Reported results are musculoskeletal system-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant \\[NCS\\]). 3) Abnormal (clinically significant \\[CS\\]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.'}, {'measure': 'Change From Baseline in Physical Examination: Skin', 'timeFrame': 'Week 0, week 16', 'description': 'Reported results are skin-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant \\[NCS\\]). 3) Abnormal (clinically significant \\[CS\\]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.'}, {'measure': 'Change From Baseline in Physical Examination: Head, Ears, Eyes, Nose, Throat and Neck', 'timeFrame': 'Week 0, week 16', 'description': 'Reported results are head, ears, eyes, nose, throat and neck-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant \\[NCS\\]). 3) Abnormal (clinically significant \\[CS\\]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.'}, {'measure': 'Change From Baseline in Vital Sign: Blood Pressure', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in blood pressure (both systolic and diastolic) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.'}, {'measure': 'Change From Baseline in Vital Sign: Pulse', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in pulse was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.'}, {'measure': 'Change From Screening in Electrocardiogram (ECG)', 'timeFrame': 'Week 0, week 16', 'description': 'Reported results are ECG findings at screening (week -6) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant \\[NCS\\]). 3) Abnormal (clinically significant \\[CS\\]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.'}, {'measure': 'Change From Screening in Fundus Photography/Fundoscopy', 'timeFrame': 'Week 0, week 16', 'description': 'Reported results are fundus photography/fundoscopy (for both left and right eye) findings at screening (week -6) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) AAbnormal (not clinically significant \\[NCS\\]). 3) Abnormal (clinically significant \\[CS\\]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.'}, {'measure': 'Change From Baseline in Haematology: Haemoglobin', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in haemoglobin was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.'}, {'measure': 'Change From Baseline in Haematology: Haematocrit', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in haematocrit was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.'}, {'measure': 'Change From Baseline in Haematology: Erythrocytes', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in erythrocytes was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.'}, {'measure': 'Change From Baseline in Haematology: Thrombocytes', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in thrombocytes was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.'}, {'measure': 'Change From Baseline in Haematology: Leucocytes', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in leucocytes was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.'}, {'measure': 'Change From Baseline in Biochemistry: Total Protein', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in total protein was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.'}, {'measure': 'Change From Baseline in Biochemistry: Creatinine', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in creatinine was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.'}, {'measure': 'Change From Baseline in Biochemistry: Alanine Aminotransferase (ALT)', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in ALT was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.'}, {'measure': 'Change From Baseline in Biochemistry: Aspartate Aminotransferase (AST)', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in AST was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.'}, {'measure': 'Change From Baseline in Biochemistry: Alkaline Phosphatase (ALP)', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in ALP was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.'}, {'measure': 'Change From Baseline in Biochemistry: Sodium', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in sodium was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.'}, {'measure': 'Change From Baseline in Biochemistry: Potassium', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in potassium was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.'}, {'measure': 'Change From Baseline in Biochemistry: Albumin', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in albumin was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.'}, {'measure': 'Change From Baseline in Biochemistry: Total Bilirubin', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in bilirubin was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.'}, {'measure': 'Change From Baseline in Urinalysis: Albumin/Creatine Ratio', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in albumin/creatine ratio was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.'}, {'measure': 'Change From Baseline in Urinalysis: Erythrocytes', 'timeFrame': 'Week 0, week 16', 'description': 'Reported results are urine erythrocytes-test findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: a) Negative, b) Trace, c) 1+, d) 2+ and e) 3+. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.'}, {'measure': 'Change From Baseline in Urinalysis: Protein', 'timeFrame': 'Week 0, week 16', 'description': 'Reported results are urine protein-test findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: a) Negative, b) Trace, c) 1+, d) 2+ e) 3+ and f) 4+. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.'}, {'measure': 'Change From Baseline in Urinalysis: Ketones', 'timeFrame': 'Week 0, week 16', 'description': 'Reported results are urine ketone-test findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: a) Negative, b) Trace, c) 1+, d) 2+ e) 3+ and f) 4+. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.'}, {'measure': 'Change From Baseline in Body Weight', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in body weight was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.'}, {'measure': 'Change From Baseline in Body Mass Index (BMI)', 'timeFrame': 'Week 0, week 16', 'description': 'Change from baseline (week 0) in BMI was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.'}, {'measure': 'Number of Change-of-infusion-sets Per Week', 'timeFrame': 'Week 0-16', 'description': 'Number of change-of-infusion-sets per week was evaluated from week 0 to week 16. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.'}, {'measure': 'Number of Subjects With at Least One Non-routine Change-of-infusion-sets Categorised by Reasons for Change-of-infusion-sets', 'timeFrame': 'Week 0-16', 'description': 'Number of subjects with at least one non-routine change-of-infusion-sets categorised by reasons for change-of-infusion-sets was evaluated from week 0 to week 16. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.\n\nReasons for change-of-infusion-sets are categorised as follows:\n\nCategory-1: A perceived occlusion by the subject Category-2: Any problems related to the infusion set Category-3: Any technical issues with the pump Category-4: Changes in the insulin solution in the infusion set or reservoir Category-5: High BG with no other explanation which made the subject change the infusion set Category-6: Infusion site reaction Category-7: Missing'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 1']}, 'referencesModule': {'references': [{'pmid': '28918652', 'type': 'RESULT', 'citation': 'Zijlstra E, Demissie M, Graungaard T, Heise T, Nosek L, Bode B. Investigation of Pump Compatibility of Fast-Acting Insulin Aspart in Subjects With Type 1 Diabetes. J Diabetes Sci Technol. 2018 Jan;12(1):145-151. doi: 10.1177/1932296817730375. Epub 2017 Sep 18.'}, {'pmid': '30537180', 'type': 'RESULT', 'citation': 'Klonoff DC, Evans ML, Lane W, Kempe HP, Renard E, DeVries JH, Graungaard T, Hyseni A, Gondolf T, Battelino T. A randomized, multicentre trial evaluating the efficacy and safety of fast-acting insulin aspart in continuous subcutaneous insulin infusion in adults with type 1 diabetes (onset 5). Diabetes Obes Metab. 2019 Apr;21(4):961-967. doi: 10.1111/dom.13610. Epub 2019 Jan 13.'}, {'pmid': '34524005', 'type': 'DERIVED', 'citation': 'Gorst-Rasmussen A, Sturis J, Ekelund M. Continuous Glucose Monitoring Sensor Glucose Levels and Insulin Pump Infusion Set Wear-Time During Treatment with Fast-Acting Insulin Aspart: A Post Hoc Analysis of Onset 5. Diabetes Technol Ther. 2022 Jan;24(1):10-17. doi: 10.1089/dia.2021.0199. Epub 2021 Dec 14.'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to investigate efficacy and safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart compared to NovoRapid® in Adults with Type 1 Diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female, age at least 18 years at the time of signing the informed consent\n* Diagnosed with T1DM (Type 1 Diabetes Mellitus) (based on clinical judgement and/or supported by laboratory analysis as per local guidelines) equal or above 1 year prior to the day of screening\n* Using the same Medtronic pump (Minimed 530G (551/751), Paradigm Veo (554/754), Paradigm Revel (523/723), Paradigm (522/722)) for CSII in a basal-bolus regimen with a rapid acting insulin analogue for at least six months prior to screening and willing to stay on the same pump model throughout the trial (if the model is changed the change should not exceed 7 consecutive days.)\n* HbA1c (glycosylated haemoglobin) 7.0-9.0% (53-75 mmol/mol) as assessed by central laboratory at screening\n* Body mass index (BMI) below or equal to 35.0 kg/m\\^2 at screening\n* Ability and willingness to take at least 3 daily meal-time insulin bolus infusions every day throughout the trial\n\nExclusion Criteria:\n\n* Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening\n* Planned coronary, carotid or peripheral artery revascularisation known on the day of screening\n* History of hospitalization for ketoacidosis below or equal to 180 days prior to the day of screening\n* Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening\n* Any condition which, in the opinion of the Investigator, might jeopardise a Subject's safety or compliance with the protocol"}, 'identificationModule': {'nctId': 'NCT02825251', 'acronym': 'Onset® 5', 'briefTitle': 'Efficacy and Safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart Compared to NovoRapid® in Adults With Type 1 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Efficacy and Safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart Compared to NovoRapid® in Adults With Type 1 Diabetes', 'orgStudyIdInfo': {'id': 'NN1218-3854'}, 'secondaryIdInfos': [{'id': '2010-024054-11', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1118-2480', 'type': 'OTHER', 'domain': 'WHO'}, {'id': 'NL54555.018.16', 'type': 'OTHER', 'domain': 'CCMO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Faster-acting insulin aspart CSII', 'interventionNames': ['Drug: Faster-acting insulin aspart']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NovoRapid® CSII', 'interventionNames': ['Drug: insulin aspart']}], 'interventions': [{'name': 'Faster-acting insulin aspart', 'type': 'DRUG', 'description': 'Injected s.c. /subcutaneously (under the skin)', 'armGroupLabels': ['Faster-acting insulin aspart CSII']}, {'name': 'insulin aspart', 'type': 'DRUG', 'description': 'Injected s.c. /subcutaneously (under the skin)', 'armGroupLabels': ['NovoRapid® CSII']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91436', 'city': 'Encino', 'state': 'California', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 34.15917, 'lon': -118.50119}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '95661', 'city': 'Roseville', 'state': 'California', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 38.75212, 'lon': -121.28801}}, {'zip': '94401', 'city': 'San 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