Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2025-12-28 @ 7:37 PM
Study NCT ID:
NCT04588259
Status:
COMPLETED
Last Update Posted:
2025-12-04
First Post:
2020-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Research Study to Compare a New Medicine "Fast-acting Insulin Aspart" to Another Medicine "Insulin Aspart" in Chinese People With Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'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'}, {'id': 'C571886', 'term': 'insulin degludec'}], '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 Office (2834)', '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': 'Run-in period up to 8 weeks, randomised treatment period up to 16 weeks', 'description': 'All presented AEs are TEAEs, defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of exposure to randomised treatment. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'NovoRapid: Run-in period', 'description': 'Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 8 weeks. Insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol.', 'otherNumAtRisk': 331, 'deathsNumAtRisk': 331, 'otherNumAffected': 32, 'seriousNumAtRisk': 331, 'deathsNumAffected': 0, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'Faster aspart', 'description': 'Participants received subcutaneous injections of NovoRapid + insulin degludec with or without metformin for 8 weeks in the run-in period, followed by Faster aspart + insulin degludec with or without metformin subcutaneously for 16 weeks in the treatment period. During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 millimole per litre (mmol/L) or 71 milligrams per decilitre (mg/dL)) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime plasma glucose (PG) between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.', 'otherNumAtRisk': 150, 'deathsNumAtRisk': 150, 'otherNumAffected': 55, 'seriousNumAtRisk': 150, 'deathsNumAffected': 0, 'seriousNumAffected': 10}, {'id': 'EG002', 'title': 'NovoRapid', 'description': 'Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 24 weeks (8 weeks run-in period + 16 weeks treatment period). During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.', 'otherNumAtRisk': 150, 'deathsNumAtRisk': 150, 'otherNumAffected': 40, 'seriousNumAtRisk': 150, 'deathsNumAffected': 0, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Diabetic retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 150, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Dyslipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 150, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 150, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numEvents': 24, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 150, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}], 'seriousEvents': [{'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Carpal tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Diabetic foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Diabetic nephropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Diabetic retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Hepatitis B', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Hypoglycaemic coma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Neuritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Postmenopausal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Small intestine adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Type 2 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Gastric Polyps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Large Intestine Polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Patella Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Glycosylated Haemoglobin (HbA1c) (Percentage [%])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster aspart', 'description': 'Participants received subcutaneous injections of NovoRapid + insulin degludec with or without metformin for 8 weeks in the run-in period, followed by Faster aspart + insulin degludec with or without metformin subcutaneously for 16 weeks in the treatment period. During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 millimole per litre (mmol/L) or 71 milligrams per decilitre (mg/dL)) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime plasma glucose (PG) between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 24 weeks (8 weeks run-in period + 16 weeks treatment period). During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.57', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '-0.54', 'spread': '0.73', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5102', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.05', 'ciLowerLimit': '-0.19', 'ciUpperLimit': '0.09', 'pValueComment': 'p-values are from the 2-sided test for treatment difference evaluated at the 5% level.', 'groupDescription': 'The outcome measure was analysed using mixed-effect model for repeated measurement (MMRM) where all calculated changes in HbA1c from baseline at visits were included in analysis. Model included treatment and stratification of type 1 diabetes mellitus/ type 2 diabetes mellitus (T1DM/T2DM) as fixed factors, HbA1c at baseline as covariate and interactions between all fixed factors and visit. An unstructured covariance matrix described the variability for the repeated measurements for a participant.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The upper limit of the 95% confidence interval (CI) for the difference between faster aspart and NovoRapid was compared to a non-inferiority margin of 0.4%. If it was below or equal to 0.4%, non-inferiority was considered to be established and effect demonstrated.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), week 16', 'description': 'Change from baseline (week 0) in HbA1c (%) as 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': 'Percentage of HbA1c', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) which included all randomised participants. Number of participants analysed = Number of participants contributed to the analysis.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in HbA1c (Millimoles Per Mole [mmol/Mol])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster aspart', 'description': 'Participants received subcutaneous injections of NovoRapid + insulin degludec with or without metformin for 8 weeks in the run-in period, followed by Faster aspart + insulin degludec with or without metformin subcutaneously for 16 weeks in the treatment period. During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 millimole per litre (mmol/L) or 71 milligrams per decilitre (mg/dL)) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime plasma glucose (PG) between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 24 weeks (8 weeks run-in period + 16 weeks treatment period). During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.18', 'spread': '6.84', 'groupId': 'OG000'}, {'value': '-5.89', 'spread': '7.94', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5102', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.52', 'ciLowerLimit': '-2.08', 'ciUpperLimit': '1.03', 'pValueComment': 'p-values are from the 2-sided test for treatment difference evaluated at the 5% level.', 'groupDescription': 'The outcome measure was analysed using a mixed-effect model for repeated measurements (MMRM) where all calculated changes in HbA1c from baseline at visits are included in the analysis. The model includes treatment and stratification (T1DM/T2DM) as fixed factors, HbA1c at baseline as covariate and interactions between all fixed factors and visit. An unstructured covariance matrix is used to describe the variability for the repeated measurements for a participant.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The upper limit of the 95% CI for the difference between faster aspart and NovoRapid was compared to a non-inferiority margin of 0.4%. If it was below or equal to 0.4%, non-inferiority was considered to be established and effect demonstrated.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), week 16', 'description': 'Change from baseline (week 0) in HbA1c (mmol/mol) 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/mol', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS which included all randomised participants. Number of participants analysed = Number of participants contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 30-minutes, 1-hour, 2-hour and 3-hour Post Prandial Glucose (PPG) Increment (Meal Test)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster aspart', 'description': 'Participants received subcutaneous injections of NovoRapid + insulin degludec with or without metformin for 8 weeks in the run-in period, followed by Faster aspart + insulin degludec with or without metformin subcutaneously for 16 weeks in the treatment period. During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 millimole per litre (mmol/L) or 71 milligrams per decilitre (mg/dL)) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime plasma glucose (PG) between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 24 weeks (8 weeks run-in period + 16 weeks treatment period). During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}], 'classes': [{'title': '30-min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.01', 'spread': '2.31', 'groupId': 'OG000'}, {'value': '0.18', 'spread': '2.15', 'groupId': 'OG001'}]}]}, {'title': '1-hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.94', 'spread': '3.08', 'groupId': 'OG000'}, {'value': '0.46', 'spread': '3.00', 'groupId': 'OG001'}]}]}, {'title': '2-hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.21', 'spread': '4.16', 'groupId': 'OG000'}, {'value': '0.64', 'spread': '4.05', 'groupId': 'OG001'}]}]}, {'title': '3-hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.77', 'spread': '4.01', 'groupId': 'OG000'}, {'value': '0.65', 'spread': '4.55', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), week 16 (30 minutes, 1 hour, 2 hour and 3 hour)', 'description': 'Change from baseline (week 0) in 30-minute, 1-hour, 2-hour and 3-hour PPG increment (meal test) was evaluated at 16 weeks. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. Meal test: The participants were given a carbohydrate-rich standardised liquid meal immediately after bolus (faster aspart or NovoRapid) infusion in the morning of the meal test. The participants were to consume the meal as quickly as possible (within 12 minutes) and blood samples were drawn after 30 minutes, 1, 2 and 3 hours from the start of the meal. PPG incremental value for each time point was derived as PPG value at that time point minus the preprandial glucose value.', 'unitOfMeasure': 'Millimoles per litre (mmol/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS which included all randomised participants. Number of participants analysed = Number of participants contributed to the analysis and Number analysed = Number of participants evaluable for each timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 30-minutes, 1-hour, 2-hour and 3-hour PPG (Meal Test)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster aspart', 'description': 'Participants received subcutaneous injections of NovoRapid + insulin degludec with or without metformin for 8 weeks in the run-in period, followed by Faster aspart + insulin degludec with or without metformin subcutaneously for 16 weeks in the treatment period. During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 millimole per litre (mmol/L) or 71 milligrams per decilitre (mg/dL)) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime plasma glucose (PG) between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 24 weeks (8 weeks run-in period + 16 weeks treatment period). During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}], 'classes': [{'title': '30-min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.64', 'spread': '3.06', 'groupId': 'OG000'}, {'value': '0.37', 'spread': '2.67', 'groupId': 'OG001'}]}]}, {'title': '1-hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.55', 'spread': '3.53', 'groupId': 'OG000'}, {'value': '0.64', 'spread': '3.10', 'groupId': 'OG001'}]}]}, {'title': '2-hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.60', 'spread': '4.53', 'groupId': 'OG000'}, {'value': '0.81', 'spread': '4.16', 'groupId': 'OG001'}]}]}, {'title': '3-hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.16', 'spread': '4.41', 'groupId': 'OG000'}, {'value': '0.87', 'spread': '4.55', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), week 16 (30 minutes, 1 hour, 2 hour and 3 hour)', 'description': 'Change from baseline (week 0) in 30-minute, 1-hour, 2-hour and 3-hour PPG (meal test) was evaluated at 16 weeks. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. Meal test: The participants were given a carbohydrate-rich standardised liquid meal immediately after bolus (faster aspart or NovoRapid) infusion in the morning of the meal test. The participants were to consume the meal as quickly as possible (within 12 minutes) and blood samples were drawn after 30 minutes, 1, 2 and 3 hours from the start of the meal.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS which included all randomised participants. Number of participants analysed = Number of participants contributed to the analysis and Number analysed = Number of participants evaluable for each timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose (FPG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster aspart', 'description': 'Participants received subcutaneous injections of NovoRapid + insulin degludec with or without metformin for 8 weeks in the run-in period, followed by Faster aspart + insulin degludec with or without metformin subcutaneously for 16 weeks in the treatment period. During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 millimole per litre (mmol/L) or 71 milligrams per decilitre (mg/dL)) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime plasma glucose (PG) between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 24 weeks (8 weeks run-in period + 16 weeks treatment period). During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.39', 'spread': '2.50', 'groupId': 'OG000'}, {'value': '0.20', 'spread': '2.11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), week 16', 'description': 'Change from baseline (week 0) in fasting plasma glucose (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': 'FAS which included all randomised participants. Number of participants analysed = Number of participants contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 7-9-7-point Self-measured Plasma Glucose (SMPG) for Mean of the 7-9-7-point Profile', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster aspart', 'description': 'Participants received subcutaneous injections of NovoRapid + insulin degludec with or without metformin for 8 weeks in the run-in period, followed by Faster aspart + insulin degludec with or without metformin subcutaneously for 16 weeks in the treatment period. During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 millimole per litre (mmol/L) or 71 milligrams per decilitre (mg/dL)) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime plasma glucose (PG) between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 24 weeks (8 weeks run-in period + 16 weeks treatment period). During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.73', 'spread': '1.55', 'groupId': 'OG000'}, {'value': '-0.76', 'spread': '1.78', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), week 16', 'description': 'Change from baseline (week 0) in mean of the 7-9-7 point SMPG profile was evaluated after 16 weeks of randomisation. 7-9-7 SMPG point profile was performed on the 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast, 60 minutes after the start of breakfast, before lunch, 60 minutes after the start of lunch, before main evening meal, 60 minutes after the start of main evening meal, and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on the following day. The mean of the 7-9-7-point profile was defined as the area under the curve profile divided by the measurement time, and was calculated using the linear trapezoidal technique. 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': 'FAS which included all randomised participants. Number of participants analysed = Number of participants contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 7-9-7-point SMPG for 1-hour PPG (Mean, Breakfast, Lunch, Main Evening Meal)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster aspart', 'description': 'Participants received subcutaneous injections of NovoRapid + insulin degludec with or without metformin for 8 weeks in the run-in period, followed by Faster aspart + insulin degludec with or without metformin subcutaneously for 16 weeks in the treatment period. During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 millimole per litre (mmol/L) or 71 milligrams per decilitre (mg/dL)) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime plasma glucose (PG) between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 24 weeks (8 weeks run-in period + 16 weeks treatment period). During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}], 'classes': [{'title': '1 hour after breakfast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.01', 'spread': '2.38', 'groupId': 'OG000'}, {'value': '-0.37', 'spread': '2.85', 'groupId': 'OG001'}]}]}, {'title': '1 hour after lunch', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.16', 'spread': '2.62', 'groupId': 'OG000'}, {'value': '-1.07', 'spread': '2.65', 'groupId': 'OG001'}]}]}, {'title': '1 hour after main evening meal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.34', 'spread': '3.10', 'groupId': 'OG000'}, {'value': '-0.68', 'spread': '2.68', 'groupId': 'OG001'}]}]}, {'title': '1 hour after all meals', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.17', 'spread': '1.92', 'groupId': 'OG000'}, {'value': '-0.70', 'spread': '2.11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), week 16', 'description': 'Change from baseline (week 0) in 1-hour PPG (breakfast, lunch, main evening meal and mean over all meals) of the 7-9-7 point SMPG profile was evaluated after 16 weeks of randomisation. 7-9-7 SMPG point profile was performed on the 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast, 60 minutes after the start of breakfast, before lunch, 60 minutes after the start of lunch, before main evening meal, 60 minutes after the start of main evening meal, and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on the following day. Results were derived from the three profiles: post-breakfast, post-lunch, post-main evening meal. 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': 'FAS which included all randomised participants. Number of participants analysed = Number of participants contributed to the analysis and Number analysed = Number of participants evaluable for each timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 7-9-7-point SMPG for PPG Increment (Mean, Breakfast, Lunch, Main Evening Meal)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster aspart', 'description': 'Participants received subcutaneous injections of NovoRapid + insulin degludec with or without metformin for 8 weeks in the run-in period, followed by Faster aspart + insulin degludec with or without metformin subcutaneously for 16 weeks in the treatment period. During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 millimole per litre (mmol/L) or 71 milligrams per decilitre (mg/dL)) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime plasma glucose (PG) between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 24 weeks (8 weeks run-in period + 16 weeks treatment period). During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}], 'classes': [{'title': 'Breakfast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.37', 'spread': '2.37', 'groupId': 'OG000'}, {'value': '-0.49', 'spread': '2.50', 'groupId': 'OG001'}]}]}, {'title': 'Lunch', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.09', 'spread': '2.89', 'groupId': 'OG000'}, {'value': '-0.19', 'spread': '2.60', 'groupId': 'OG001'}]}]}, {'title': 'Main evening meal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.34', 'spread': '2.69', 'groupId': 'OG000'}, {'value': '0.15', 'spread': '2.69', 'groupId': 'OG001'}]}]}, {'title': 'All meals', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.95', 'spread': '1.60', 'groupId': 'OG000'}, {'value': '-0.22', 'spread': '1.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), week 16', 'description': 'Change from baseline (week 0) in PPG increment of the 7-9-7 point SMPG profile was evaluated after 16 weeks of randomisation. 7-9-7 SMPG point profile was performed on the 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast, 60 minutes after the start of breakfast, before lunch, 60 minutes after the start of lunch, before main evening meal, 60 minutes after the start of main evening meal, and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on the following day. PPG increment for each meal was derived from the 7-point and 9-point profile as the difference between PPG values and the PG value before the meal in each separate profile. 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': 'FAS which included all randomised participants. Number of participants analysed = Number of participants contributed to the analysis and Number analysed = Number of participants evaluable for each timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 7-9-7-point SMPG for Fluctuation in 7-9-7-point Profile: Ratio to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster aspart', 'description': 'Participants received subcutaneous injections of NovoRapid + insulin degludec with or without metformin for 8 weeks in the run-in period, followed by Faster aspart + insulin degludec with or without metformin subcutaneously for 16 weeks in the treatment period. During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 millimole per litre (mmol/L) or 71 milligrams per decilitre (mg/dL)) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime plasma glucose (PG) between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 24 weeks (8 weeks run-in period + 16 weeks treatment period). During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.77', 'spread': '55.19', 'groupId': 'OG000'}, {'value': '0.73', 'spread': '47.37', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0), week 16', 'description': 'Fluctuation in SMPG profile was the average absolute difference from the mean of the SMPG profile. Change from baseline is represented as ratio to baseline value. 7-9-7 SMPG point profile was performed on the 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast, 60 minutes after the start of breakfast, before lunch, 60 minutes after the start of lunch, before main evening meal, 60 minutes after the start of main evening meal, and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on the following day. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.', 'unitOfMeasure': 'Ratio of 7-9-7-point SMPG', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS which included all randomised participants. Number of participants analysed = Number of participants contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Achieved HbA1c Less Than (<) 7.0 (Percent [%]) (Yes/No)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster aspart', 'description': 'Participants received subcutaneous injections of NovoRapid + insulin degludec with or without metformin for 8 weeks in the run-in period, followed by Faster aspart + insulin degludec with or without metformin subcutaneously for 16 weeks in the treatment period. During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 millimole per litre (mmol/L) or 71 milligrams per decilitre (mg/dL)) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime plasma glucose (PG) between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 24 weeks (8 weeks run-in period + 16 weeks treatment period). During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At week 16', 'description': 'Number of participants who achieved HbA1c \\< 7% measured as 53 mmol/mol at week 16 is presented. In the reported data, "Yes" infers the number of participants who have achieved HbA1c values \\< 7% and "No" infers the number of participants who have not achieved HbA1c values \\< 7%. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS which included all randomised participants.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Achieved HbA1c <7.0% Without Severe Hypoglycaemia Episodes (Yes/No)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster aspart', 'description': 'Participants received subcutaneous injections of NovoRapid + insulin degludec with or without metformin for 8 weeks in the run-in period, followed by Faster aspart + insulin degludec with or without metformin subcutaneously for 16 weeks in the treatment period. During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 millimole per litre (mmol/L) or 71 milligrams per decilitre (mg/dL)) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime plasma glucose (PG) between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 24 weeks (8 weeks run-in period + 16 weeks treatment period). During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At week 16', 'description': 'Number of participants who achieved HbA1c \\< 7% (measured as 53 mmol/mol) without severe hypoglycaemia episodes at week 16 is presented. In the reported data, "Yes" infers the number of participants who have achieved HbA1c values \\< 7% without severe hypoglycaemia episodes and "No" infers the number of participants who have not achieved HbA1c values less than the 7%. without severe hypoglycaemia episodes The results are based on the last in-trial value, which included the last available measurement in the in-trial period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS which included all randomised participants.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Achieved PPG Target (Overall Mean of Daily PPG Measurements in SMPG) for Overall PPG (1-hour) Less Than or Equal (≤) to 7.8 mmol/L (Yes/No)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster aspart', 'description': 'Participants received subcutaneous injections of NovoRapid + insulin degludec with or without metformin for 8 weeks in the run-in period, followed by Faster aspart + insulin degludec with or without metformin subcutaneously for 16 weeks in the treatment period. During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 millimole per litre (mmol/L) or 71 milligrams per decilitre (mg/dL)) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime plasma glucose (PG) between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 24 weeks (8 weeks run-in period + 16 weeks treatment period). During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At week 16', 'description': 'Number of participants who achieved overall PPG (1-hour) ≤ 7.8 mmol/L measured as 140 milligrams per deciliter (mg/dL) at week 16 is presented. In the reported data, "Yes" infers the number of participants who have achieved overall PPG (1-hour) values ≤ 7.8 mmol/L and "No" infers the number of participants who have not achieved overall PPG (1-hour) values ≤ 7.8 mmol/L. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS which included all randomised participants.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Achieved PPG Target (Overall Mean of Daily PPG Measurements in SMPG) for Overall PPG (1-hour) Less Than or Equal (≤) to 7.8 mmol/L Without Severe Hypoglycaemia (Yes/No)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster aspart', 'description': 'Participants received subcutaneous injections of NovoRapid + insulin degludec with or without metformin for 8 weeks in the run-in period, followed by Faster aspart + insulin degludec with or without metformin subcutaneously for 16 weeks in the treatment period. During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 millimole per litre (mmol/L) or 71 milligrams per decilitre (mg/dL)) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime plasma glucose (PG) between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 24 weeks (8 weeks run-in period + 16 weeks treatment period). During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At week 16', 'description': 'Number of participants who achieved overall PPG (1-hour) ≤ 7.8 mmol/L (measured as 140 mg/dL) without severe hypoglycaemia at week 16 is presented. In the reported data, "Yes" infers the number of participants who have achieved overall PPG (1-hour) values ≤ 7.8 mmol/L without severe hypoglycaemia and "No" infers the number of participants who have not achieved overall PPG (1-hour) values ≤ 7.8 mmol/L without severe hypoglycaemia. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS which included all randomised participants.'}, {'type': 'SECONDARY', 'title': 'Insulin Dose (Units/Day): Total Basal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster aspart', 'description': 'Participants received subcutaneous injections of NovoRapid + insulin degludec with or without metformin for 8 weeks in the run-in period, followed by Faster aspart + insulin degludec with or without metformin subcutaneously for 16 weeks in the treatment period. During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 millimole per litre (mmol/L) or 71 milligrams per decilitre (mg/dL)) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime plasma glucose (PG) between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 24 weeks (8 weeks run-in period + 16 weeks treatment period). During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.01', 'spread': '14.37', 'groupId': 'OG000'}, {'value': '27.21', 'spread': '13.30', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At week 16', 'description': 'Total basal insulin dose 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': 'Units/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set (SAS) which included all participants receiving at least one dose of randomised treatment. Number of participants analysed = Number of participants contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Insulin Dose (Units/Day): Total Bolus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster aspart', 'description': 'Participants received subcutaneous injections of NovoRapid + insulin degludec with or without metformin for 8 weeks in the run-in period, followed by Faster aspart + insulin degludec with or without metformin subcutaneously for 16 weeks in the treatment period. During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 millimole per litre (mmol/L) or 71 milligrams per decilitre (mg/dL)) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime plasma glucose (PG) between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 24 weeks (8 weeks run-in period + 16 weeks treatment period). During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}], 'classes': [{'categories': [{'measurements': [{'value': '39.49', 'spread': '17.08', 'groupId': 'OG000'}, {'value': '39.16', 'spread': '16.90', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At week 16', 'description': 'Total bolus insulin dose 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': 'Units/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS which included all participants receiving at least one dose of randomised treatment. Number of participants analysed = Number of participants contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Insulin Dose (Units/Day): Individual Meal Insulin Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster aspart', 'description': 'Participants received subcutaneous injections of NovoRapid + insulin degludec with or without metformin for 8 weeks in the run-in period, followed by Faster aspart + insulin degludec with or without metformin subcutaneously for 16 weeks in the treatment period. During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 millimole per litre (mmol/L) or 71 milligrams per decilitre (mg/dL)) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime plasma glucose (PG) between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 24 weeks (8 weeks run-in period + 16 weeks treatment period). During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}], 'classes': [{'title': 'Breakfast', 'categories': [{'measurements': [{'value': '12.00', 'spread': '5.90', 'groupId': 'OG000'}, {'value': '11.54', 'spread': '6.12', 'groupId': 'OG001'}]}]}, {'title': 'Lunch', 'categories': [{'measurements': [{'value': '13.67', 'spread': '6.02', 'groupId': 'OG000'}, {'value': '13.84', 'spread': '6.11', 'groupId': 'OG001'}]}]}, {'title': 'Main evening meal', 'categories': [{'measurements': [{'value': '13.82', 'spread': '6.38', 'groupId': 'OG000'}, {'value': '13.78', 'spread': '5.89', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At week 16', 'description': 'Individual meal time bolus insulin dose for breakast, lunch and main evening meal 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': 'Units/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS which included all participants receiving at least one dose of randomised treatment. Number of participants analysed = Number of participants contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Insulin Dose (Units/kg/Day): Total Basal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster aspart', 'description': 'Participants received subcutaneous injections of NovoRapid + insulin degludec with or without metformin for 8 weeks in the run-in period, followed by Faster aspart + insulin degludec with or without metformin subcutaneously for 16 weeks in the treatment period. During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 millimole per litre (mmol/L) or 71 milligrams per decilitre (mg/dL)) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime plasma glucose (PG) between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 24 weeks (8 weeks run-in period + 16 weeks treatment period). During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.37', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '0.39', 'spread': '0.17', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At week 16', 'description': 'Total basal insulin dose 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': 'Units/(kilogram) kg/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS which included all participants receiving at least one dose of randomised treatment. Number of participants analysed = Number of participants contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Insulin Dose (Units/kg/Day): Total Bolus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster aspart', 'description': 'Participants received subcutaneous injections of NovoRapid + insulin degludec with or without metformin for 8 weeks in the run-in period, followed by Faster aspart + insulin degludec with or without metformin subcutaneously for 16 weeks in the treatment period. During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 millimole per litre (mmol/L) or 71 milligrams per decilitre (mg/dL)) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime plasma glucose (PG) between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 24 weeks (8 weeks run-in period + 16 weeks treatment period). During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.56', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '0.57', 'spread': '0.25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At week 16', 'description': 'Total bolus insulin dose 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': 'Units/kg/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS which included all participants receiving at least one dose of randomised treatment. Number of participants analysed = Number of participants contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Insulin Dose (Units/kg/Day): Individual Meal Insulin Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster aspart', 'description': 'Participants received subcutaneous injections of NovoRapid + insulin degludec with or without metformin for 8 weeks in the run-in period, followed by Faster aspart + insulin degludec with or without metformin subcutaneously for 16 weeks in the treatment period. During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 millimole per litre (mmol/L) or 71 milligrams per decilitre (mg/dL)) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime plasma glucose (PG) between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 24 weeks (8 weeks run-in period + 16 weeks treatment period). During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}], 'classes': [{'title': 'Breakfast', 'categories': [{'measurements': [{'value': '0.17', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '0.17', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'Lunch', 'categories': [{'measurements': [{'value': '0.19', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '0.20', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'Main evening meal', 'categories': [{'measurements': [{'value': '0.20', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '0.20', 'spread': '0.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At week 16', 'description': 'Individual meal time bolus insulin dose for breakast, lunch and main evening meal 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': 'Units/kg/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS which included all participants receiving at least one dose of randomised treatment. Number of participants analysed = Number of participants contributed to the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Treatment Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster aspart', 'description': 'Participants received subcutaneous injections of NovoRapid + insulin degludec with or without metformin for 8 weeks in the run-in period, followed by Faster aspart + insulin degludec with or without metformin subcutaneously for 16 weeks in the treatment period. During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 millimole per litre (mmol/L) or 71 milligrams per decilitre (mg/dL)) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime plasma glucose (PG) between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 24 weeks (8 weeks run-in period + 16 weeks treatment period). During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}], 'classes': [{'categories': [{'measurements': [{'value': '285', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline (week 0) to 16 weeks after randomisation', 'description': 'Number of treatment emergent adverse events were recorded from week 0 to week 16. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of exposure to randomised treatment.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS which included all participants receiving at least one dose of randomised treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Treatment Emergent Injection Site Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster aspart', 'description': 'Participants received subcutaneous injections of NovoRapid + insulin degludec with or without metformin for 8 weeks in the run-in period, followed by Faster aspart + insulin degludec with or without metformin subcutaneously for 16 weeks in the treatment period. During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 millimole per litre (mmol/L) or 71 milligrams per decilitre (mg/dL)) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime plasma glucose (PG) between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 24 weeks (8 weeks run-in period + 16 weeks treatment period). During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline (week 0) to 16 weeks after randomisation', 'description': 'Number of treatment emergent injection site reactions were recorded 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': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS which included all participants receiving at least one dose of randomised treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the American Diabetes Association (ADA) Definition and Novo Nordisk (NN) Definition: Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster aspart', 'description': 'Participants received subcutaneous injections of NovoRapid + insulin degludec with or without metformin for 8 weeks in the run-in period, followed by Faster aspart + insulin degludec with or without metformin subcutaneously for 16 weeks in the treatment period. During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 millimole per litre (mmol/L) or 71 milligrams per decilitre (mg/dL)) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime plasma glucose (PG) between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 24 weeks (8 weeks run-in period + 16 weeks treatment period). During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}], 'classes': [{'title': 'ADA: Severe', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Documented symptomatic', 'categories': [{'measurements': [{'value': '915', 'groupId': 'OG000'}, {'value': '971', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Asymptomatic', 'categories': [{'measurements': [{'value': '453', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Probable symptomatic', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Pseudo-hypoglycaemia', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Unclassifiable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'NN: BG confirmed', 'categories': [{'measurements': [{'value': '404', 'groupId': 'OG000'}, {'value': '438', 'groupId': 'OG001'}]}]}, {'title': 'NN: Severe or BG confirmed symptomatic', 'categories': [{'measurements': [{'value': '316', 'groupId': 'OG000'}, {'value': '347', 'groupId': 'OG001'}]}]}, {'title': 'NN: Severe or BG confirmed', 'categories': [{'measurements': [{'value': '404', 'groupId': 'OG000'}, {'value': '438', 'groupId': 'OG001'}]}]}, {'title': 'NN: Unclassifiable', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline (week 0) to 16 weeks after randomisation', 'description': 'ADA classification of hypoglycaemia as follows: 1) Severe: Requiring assistance to actively administer carbohydrate/glucagon/take other corrective actions. 2) Documented symptomatic: PG ≤3.9 mmol/L with symptoms. 3) Asymptomatic: PG ≤3.9 mmol/L without symptoms. 4) Probable symptomatic: No measurement with symptoms. 5) Pseudo-hypoglycaemia: PG \\>3.9 mmol/L with symptoms. 6) Unclassifiable. NN classification of hypoglycaemia as follows: 1) BG confirmed: PG \\<3.1 mmol/L with/without symptoms. 2) Severe or BG confirmed symptomatic: Severe as per ADA and BG confirmed by PG \\<3.1 mmol/L with symptoms. 3) Severe or BG confirmed: Severe as per ADA and BG confirmed by PG \\<3.1 mmol/L with/without symptoms. 4) Unclassifiable. Not able to self-treat-unclassifiable: Not able to self-treat but not classifiable as severe hypoglycaemia.', 'unitOfMeasure': 'Episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS which included all participants receiving at least one dose of randomised treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the ADA Definition and NN Definition: Day Time Hypoglycaemic Episodes (00:01-05:59 - Both Inclusive)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster aspart', 'description': 'Participants received subcutaneous injections of NovoRapid + insulin degludec with or without metformin for 8 weeks in the run-in period, followed by Faster aspart + insulin degludec with or without metformin subcutaneously for 16 weeks in the treatment period. During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 millimole per litre (mmol/L) or 71 milligrams per decilitre (mg/dL)) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime plasma glucose (PG) between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 24 weeks (8 weeks run-in period + 16 weeks treatment period). During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}], 'classes': [{'title': 'ADA: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Documented symptomatic', 'categories': [{'measurements': [{'value': '863', 'groupId': 'OG000'}, {'value': '927', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Asymptomatic', 'categories': [{'measurements': [{'value': '440', 'groupId': 'OG000'}, {'value': '390', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Probable symptomatic', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Pseudo-hypoglycaemia', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Unclassifiable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'NN: BG confirmed', 'categories': [{'measurements': [{'value': '375', 'groupId': 'OG000'}, {'value': '417', 'groupId': 'OG001'}]}]}, {'title': 'NN: Severe or BG confirmed symptomatic', 'categories': [{'measurements': [{'value': '292', 'groupId': 'OG000'}, {'value': '327', 'groupId': 'OG001'}]}]}, {'title': 'NN: Severe or BG confirmed', 'categories': [{'measurements': [{'value': '375', 'groupId': 'OG000'}, {'value': '417', 'groupId': 'OG001'}]}]}, {'title': 'NN: Unclassifiable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline (week 0) to 16 weeks after randomisation', 'description': 'Number of treatment emergent day time hypoglycaemic episodes as per ADA and NN definitions were evaluated. ADA classification of hypoglycaemia as follows: 1) Severe: Requiring assistance to actively administer carbohydrate/glucagon/take other corrective actions. 2) Documented symptomatic: PG ≤3.9 mmol/L with symptoms. 3) Asymptomatic: PG ≤3.9 mmol/L without symptoms. 4) Probable symptomatic: No measurement with symptoms. 5) Pseudo-hypoglycaemia: PG \\>3.9 mmol/L with symptoms. 6) Unclassifiable. NN classification of hypoglycaemia as follows: 1) BG confirmed: PG \\<3.1 mmol/L with/without symptoms. 2) Severe or BG confirmed symptomatic: Severe as per ADA and BG confirmed by PG \\<3.1 mmol/L with symptoms. 3) Severe or BG confirmed: Severe as per ADA and BG confirmed by PG \\<3.1 mmol/L with/without symptoms. 4) Unclassifiable. Not able to self-treat-unclassifiable: Not able to self-treat but not classifiable as severe hypoglycaemia.', 'unitOfMeasure': 'Episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS which included all participants receiving at least one dose of randomised treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the ADA Definition and NN Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Both Inclusive)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster aspart', 'description': 'Participants received subcutaneous injections of NovoRapid + insulin degludec with or without metformin for 8 weeks in the run-in period, followed by Faster aspart + insulin degludec with or without metformin subcutaneously for 16 weeks in the treatment period. During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 millimole per litre (mmol/L) or 71 milligrams per decilitre (mg/dL)) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime plasma glucose (PG) between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 24 weeks (8 weeks run-in period + 16 weeks treatment period). During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}], 'classes': [{'title': 'ADA: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Documented symptomatic', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Asymptomatic', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Probable symptomatic', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Pseudo-hypoglycaemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Unclassifiable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'NN: BG confirmed', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'NN: Severe or BG confirmed symptomatic', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'NN: Severe or BG confirmed', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'NN: Unclassifiable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline (week 0) to 16 weeks after randomisation', 'description': 'Number of treatment emergent nocturnal hypoglycaemic episodes as per ADA and NN definitions were evaluated. ADA classification of hypoglycaemia as follows: 1) Severe: Requiring assistance to actively administer carbohydrate/glucagon/take other corrective actions. 2) Documented symptomatic: PG ≤3.9 mmol/L with symptoms. 3) Asymptomatic: PG ≤3.9 mmol/L without symptoms. 4) Probable symptomatic: No measurement with symptoms. 5) Pseudo-hypoglycaemia: PG \\>3.9 mmol/L with symptoms. 6) Unclassifiable. NN classification of hypoglycaemia as follows: 1) BG confirmed: PG \\<3.1 mmol/L with/without symptoms. 2) Severe or BG confirmed symptomatic: Severe as per ADA and BG confirmed by PG \\<3.1 mmol/L with symptoms. 3) Severe or BG confirmed: Severe as per ADA and BG confirmed by PG \\<3.1 mmol/L with/without symptoms. 4) Unclassifiable. Not able to self-treat-unclassifiable: Not able to self-treat but not classifiable as severe hypoglycaemia.', 'unitOfMeasure': 'Episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS which included all participants receiving at least one dose of randomised treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the ADA Definition and NN Definition: Hypoglycaemic Episodes From Start of Meal Until 30 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster aspart', 'description': 'Participants received subcutaneous injections of NovoRapid + insulin degludec with or without metformin for 8 weeks in the run-in period, followed by Faster aspart + insulin degludec with or without metformin subcutaneously for 16 weeks in the treatment period. During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 millimole per litre (mmol/L) or 71 milligrams per decilitre (mg/dL)) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime plasma glucose (PG) between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 24 weeks (8 weeks run-in period + 16 weeks treatment period). During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}], 'classes': [{'title': 'ADA: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Documented symptomatic', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Asymptomatic', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Probable symptomatic', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Pseudo-hypoglycaemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Unclassifiable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'NN: BG confirmed', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'NN: Severe or BG confirmed symptomatic', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'NN: Severe or BG confirmed', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'NN: Unclassifiable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline (week 0) to 16 weeks after randomisation', 'description': 'Number of treatment emergent hypoglycaemic episodes as per ADA and NN definitions were evaluated during first 30-mins after start of meal. ADA classification of hypoglycaemia as follows: 1) Severe: Requiring assistance to actively administer carbohydrate/glucagon/take other corrective actions. 2) Documented symptomatic: PG ≤3.9 mmol/L with symptoms. 3) Asymptomatic: PG ≤3.9 mmol/L without symptoms. 4) Probable symptomatic: No measurement with symptoms. 5) Pseudo-hypoglycaemia: PG \\>3.9 mmol/L with symptoms. 6) Unclassifiable. NN classification of hypoglycaemia as follows: 1) BG confirmed: PG \\<3.1 mmol/L with/without symptoms. 2) Severe or BG confirmed symptomatic: Severe as per ADA and BG confirmed by PG \\<3.1 mmol/L with symptoms. 3) Severe or BG confirmed: Severe as per ADA and BG confirmed by PG \\<3.1 mmol/L with/without symptoms. 4) Unclassifiable. Not able to self-treat-unclassifiable: Not able to self-treat but not classifiable as severe hypoglycaemia.', 'unitOfMeasure': 'Episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS which included all participants receiving at least one dose of randomised treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the ADA Definition and NN Definition: Hypoglycaemic Episodes From Start of Meal Until 1 Hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster aspart', 'description': 'Participants received subcutaneous injections of NovoRapid + insulin degludec with or without metformin for 8 weeks in the run-in period, followed by Faster aspart + insulin degludec with or without metformin subcutaneously for 16 weeks in the treatment period. During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 millimole per litre (mmol/L) or 71 milligrams per decilitre (mg/dL)) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime plasma glucose (PG) between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 24 weeks (8 weeks run-in period + 16 weeks treatment period). During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}], 'classes': [{'title': 'ADA: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Documented symptomatic', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Asymptomatic', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Probable symptomatic', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Pseudo-hypoglycaemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Unclassifiable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'NN: BG confirmed', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'NN: Severe or BG confirmed symptomatic', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'NN: Severe or BG confirmed', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'NN: Unclassifiable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline (week 0) to 16 weeks after randomisation', 'description': 'Number of treatment emergent hypoglycaemic episodes as per ADA and NN definitions were evaluated during first 1 hour after start of meal. ADA classification of hypoglycaemia as follows: 1) Severe: Requiring assistance to actively administer carbohydrate/glucagon/take other corrective actions. 2) Documented symptomatic: PG ≤3.9 mmol/L with symptoms. 3) Asymptomatic: PG ≤3.9 mmol/L without symptoms. 4) Probable symptomatic: No measurement with symptoms. 5) Pseudo-hypoglycaemia: PG \\>3.9 mmol/L with symptoms. 6) Unclassifiable. NN classification of hypoglycaemia as follows: 1) BG confirmed: PG \\<3.1 mmol/L with/without symptoms. 2) Severe or BG confirmed symptomatic: Severe as per ADA and BG confirmed by PG \\<3.1 mmol/L with symptoms. 3) Severe or BG confirmed: Severe as per ADA and BG confirmed by PG \\<3.1 mmol/L with/without symptoms. 4) Unclassifiable. Not able to self-treat-unclassifiable: Not able to self-treat but not classifiable as severe hypoglycaemia.', 'unitOfMeasure': 'Episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS which included all participants receiving at least one dose of randomised treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the ADA Definition and NN Definition: Hypoglycaemic Episodes From Start of Meal Until 2 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster aspart', 'description': 'Participants received subcutaneous injections of NovoRapid + insulin degludec with or without metformin for 8 weeks in the run-in period, followed by Faster aspart + insulin degludec with or without metformin subcutaneously for 16 weeks in the treatment period. During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 millimole per litre (mmol/L) or 71 milligrams per decilitre (mg/dL)) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime plasma glucose (PG) between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 24 weeks (8 weeks run-in period + 16 weeks treatment period). During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}], 'classes': [{'title': 'ADA: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Documented symptomatic', 'categories': [{'measurements': [{'value': '126', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Asymptomatic', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Probable symptomatic', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Pseudo-hypoglycaemia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Unclassifiable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'NN: BG confirmed', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}]}, {'title': 'NN: Severe or BG confirmed symptomatic', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}]}, {'title': 'NN: Severe or BG confirmed', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}]}, {'title': 'NN: Unclassifiable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline (week 0) to 16 weeks after randomisation', 'description': 'Number of treatment emergent hypoglycaemic episodes as per ADA and NN definitions were evaluated during first 2 hours after start of meal. ADA classification of hypoglycaemia as follows: 1) Severe: Requiring assistance to actively administer carbohydrate/glucagon/take other corrective actions. 2) Documented symptomatic: PG ≤3.9 mmol/L with symptoms. 3) Asymptomatic: PG ≤3.9 mmol/L without symptoms. 4) Probable symptomatic: No measurement with symptoms. 5) Pseudo-hypoglycaemia: PG \\>3.9 mmol/L with symptoms. 6) Unclassifiable. NN classification of hypoglycaemia as follows: 1) BG confirmed: PG \\<3.1 mmol/L with/without symptoms. 2) Severe or BG confirmed symptomatic: Severe as per ADA and BG confirmed by PG \\<3.1 mmol/L with symptoms. 3) Severe or BG confirmed: Severe as per ADA and BG confirmed by PG \\<3.1 mmol/L with/without symptoms. 4) Unclassifiable. Not able to self-treat-unclassifiable: Not able to self-treat but not classifiable as severe hypoglycaemia.', 'unitOfMeasure': 'Episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS which included all participants receiving at least one dose of randomised treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the ADA Definition and NN Definition: Hypoglycaemic Episodes From Start of Meal Until 4 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster aspart', 'description': 'Participants received subcutaneous injections of NovoRapid + insulin degludec with or without metformin for 8 weeks in the run-in period, followed by Faster aspart + insulin degludec with or without metformin subcutaneously for 16 weeks in the treatment period. During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 millimole per litre (mmol/L) or 71 milligrams per decilitre (mg/dL)) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime plasma glucose (PG) between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 24 weeks (8 weeks run-in period + 16 weeks treatment period). During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}], 'classes': [{'title': 'ADA: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Documented symptomatic', 'categories': [{'measurements': [{'value': '391', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Asymptomatic', 'categories': [{'measurements': [{'value': '142', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Probable symptomatic', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Pseudo-hypoglycaemia', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Unclassifiable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'NN: BG confirmed', 'categories': [{'measurements': [{'value': '213', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}]}]}, {'title': 'NN: Severe or BG confirmed symptomatic', 'categories': [{'measurements': [{'value': '176', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}]}, {'title': 'NN: Severe or BG confirmed', 'categories': [{'measurements': [{'value': '213', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}]}]}, {'title': 'NN: Unclassifiable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline (week 0) to 16 weeks after randomisation', 'description': 'Number of treatment emergent hypoglycaemic episodes as per ADA and NN definitions were evaluated during first 4 hours after start of meal. ADA classification of hypoglycaemia as follows: 1) Severe: Requiring assistance to actively administer carbohydrate/glucagon/take other corrective actions. 2) Documented symptomatic: PG ≤3.9 mmol/L with symptoms. 3) Asymptomatic: PG ≤3.9 mmol/L without symptoms. 4) Probable symptomatic: No measurement with symptoms. 5) Pseudo-hypoglycaemia: PG \\>3.9 mmol/L with symptoms. 6) Unclassifiable. NN classification of hypoglycaemia as follows: 1) BG confirmed: PG \\<3.1 mmol/L with/without symptoms. 2) Severe or BG confirmed symptomatic: Severe as per ADA and BG confirmed by PG \\<3.1 mmol/L with symptoms. 3) Severe or BG confirmed: Severe as per ADA and BG confirmed by PG \\<3.1 mmol/L with/without symptoms. 4) Unclassifiable. Not able to self-treat-unclassifiable: Not able to self-treat but not classifiable as severe hypoglycaemia.', 'unitOfMeasure': 'Episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS which included all participants receiving at least one dose of randomised treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the ADA Definition and NN Definition: Hypoglycaemic Episodes From 2 Hours (Exclusive) to 4 Hours (Inclusive) After Start of Meal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster aspart', 'description': 'Participants received subcutaneous injections of NovoRapid + insulin degludec with or without metformin for 8 weeks in the run-in period, followed by Faster aspart + insulin degludec with or without metformin subcutaneously for 16 weeks in the treatment period. During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 millimole per litre (mmol/L) or 71 milligrams per decilitre (mg/dL)) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime plasma glucose (PG) between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}, {'id': 'OG001', 'title': 'NovoRapid', 'description': 'Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 24 weeks (8 weeks run-in period + 16 weeks treatment period). During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}], 'classes': [{'title': 'ADA: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Documented symptomatic', 'categories': [{'measurements': [{'value': '265', 'groupId': 'OG000'}, {'value': '286', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Asymptomatic', 'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Probable symptomatic', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Pseudo-hypoglycaemia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'ADA: Unclassifiable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'NN: BG confirmed', 'categories': [{'measurements': [{'value': '147', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}]}, {'title': 'NN: Severe or BG confirmed symptomatic', 'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}]}, {'title': 'NN: Severe or BG confirmed', 'categories': [{'measurements': [{'value': '147', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}]}, {'title': 'NN: Unclassifiable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline (week 0) to 16 weeks after randomisation', 'description': 'Number of treatment emergent hypoglycaemic episodes as per ADA and NN definitions were evaluated from 2 hours to 4 hours after start of meal. ADA classification of hypoglycaemia as follows: 1) Severe: Requiring assistance to actively administer carbohydrate/glucagon/take other corrective actions. 2) Documented symptomatic: PG ≤3.9 mmol/L with symptoms. 3) Asymptomatic: PG ≤3.9 mmol/L without symptoms. 4) Probable symptomatic: No measurement with symptoms. 5) Pseudo-hypoglycaemia: PG \\>3.9 mmol/L with symptoms. 6) Unclassifiable. NN classification of hypoglycaemia as follows: 1) BG confirmed: PG \\<3.1 mmol/L with/without symptoms. 2) Severe or BG confirmed symptomatic: Severe as per ADA and BG confirmed by PG \\<3.1 mmol/L with symptoms. 3) Severe or BG confirmed: Severe as per ADA and BG confirmed by PG \\<3.1 mmol/L with/without symptoms. 4) Unclassifiable. Not able to self-treat-unclassifiable: Not able to self-treat but not classifiable as severe hypoglycaemia.', 'unitOfMeasure': 'Episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS which included all participants receiving at least one dose of randomised treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Faster aspart', 'description': 'Participants received subcutaneous injections of NovoRapid + insulin degludec with or without metformin for 8 weeks in the run-in period, followed by Faster aspart + insulin degludec with or without metformin subcutaneously for 16 weeks in the treatment period. During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 millimole per litre (mmol/L) or 71 milligrams per decilitre (mg/dL)) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime plasma glucose (PG) between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}, {'id': 'FG001', 'title': 'NovoRapid', 'description': 'Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 24 weeks (8 weeks run-in period + 16 weeks treatment period). During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}], 'periods': [{'title': 'Run-in period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '331'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '300'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '31'}]}], 'dropWithdraws': [{'type': 'Run-in failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'Withdrawn before randomisation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '8'}]}]}, {'title': 'Treatment period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '150'}, {'groupId': 'FG001', 'numSubjects': '150'}]}, {'type': 'Full analysis set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '150'}, {'groupId': 'FG001', 'numSubjects': '150'}]}, {'type': 'Safety analysis set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '150'}, {'groupId': 'FG001', 'numSubjects': '150'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '144'}, {'groupId': 'FG001', 'numSubjects': '144'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}], 'recruitmentDetails': 'The trial was conducted at 31 sites in China.', 'preAssignmentDetails': "The trial included an 8-week run-in period and a 16-week treatment period. During the run-in period, participants received NovoRapid both in combination with insulin degludec with or without metformin primarily for optimisation of the basal insulin treatment. Participants were then randomised 1:1 to receive either 'Faster aspart + insulin degludec with or without metformin' or 'NovoRapid + insulin degludec with or without metformin' during the treatment period."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Faster Aspart', 'description': 'Participants received subcutaneous injections of NovoRapid + insulin degludec with or without metformin for 8 weeks in the run-in period, followed by Faster aspart + insulin degludec with or without metformin subcutaneously for 16 weeks in the treatment period. During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 millimole per litre (mmol/L) or 71 milligrams per decilitre (mg/dL)) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime plasma glucose (PG) between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}, {'id': 'BG001', 'title': 'NovoRapid', 'description': 'Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 24 weeks (8 weeks run-in period + 16 weeks treatment period). During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.79', 'spread': '10.65', 'groupId': 'BG000'}, {'value': '55.24', 'spread': '12.02', 'groupId': 'BG001'}, {'value': '56.02', 'spread': '11.36', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '149', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '299', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '150', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '300', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full analysis set (FAS) which included all randomised participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-11-30', 'size': 2149086, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-07-05T06:30', 'hasProtocol': True}, {'date': '2022-09-26', 'size': 1090718, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-07-05T06:30', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Sponsor staff involved in the clinical trial is masked according to company standard procedures'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 331}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2022-08-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-27', 'studyFirstSubmitDate': '2020-10-09', 'resultsFirstSubmitDate': '2023-07-05', 'studyFirstSubmitQcDate': '2020-10-09', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2024-03-16', 'studyFirstPostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Glycosylated Haemoglobin (HbA1c) (Percentage [%])', 'timeFrame': 'Baseline (week 0), week 16', 'description': 'Change from baseline (week 0) in HbA1c (%) as 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 HbA1c (Millimoles Per Mole [mmol/Mol])', 'timeFrame': 'Baseline (week 0), week 16', 'description': 'Change from baseline (week 0) in HbA1c (mmol/mol) 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.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in 30-minutes, 1-hour, 2-hour and 3-hour Post Prandial Glucose (PPG) Increment (Meal Test)', 'timeFrame': 'Baseline (week 0), week 16 (30 minutes, 1 hour, 2 hour and 3 hour)', 'description': 'Change from baseline (week 0) in 30-minute, 1-hour, 2-hour and 3-hour PPG increment (meal test) was evaluated at 16 weeks. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. Meal test: The participants were given a carbohydrate-rich standardised liquid meal immediately after bolus (faster aspart or NovoRapid) infusion in the morning of the meal test. The participants were to consume the meal as quickly as possible (within 12 minutes) and blood samples were drawn after 30 minutes, 1, 2 and 3 hours from the start of the meal. PPG incremental value for each time point was derived as PPG value at that time point minus the preprandial glucose value.'}, {'measure': 'Change From Baseline in 30-minutes, 1-hour, 2-hour and 3-hour PPG (Meal Test)', 'timeFrame': 'Baseline (week 0), week 16 (30 minutes, 1 hour, 2 hour and 3 hour)', 'description': 'Change from baseline (week 0) in 30-minute, 1-hour, 2-hour and 3-hour PPG (meal test) was evaluated at 16 weeks. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. Meal test: The participants were given a carbohydrate-rich standardised liquid meal immediately after bolus (faster aspart or NovoRapid) infusion in the morning of the meal test. The participants were to consume the meal as quickly as possible (within 12 minutes) and blood samples were drawn after 30 minutes, 1, 2 and 3 hours from the start of the meal.'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose (FPG)', 'timeFrame': 'Baseline (week 0), week 16', 'description': 'Change from baseline (week 0) in fasting plasma glucose (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': 'Change From Baseline in 7-9-7-point Self-measured Plasma Glucose (SMPG) for Mean of the 7-9-7-point Profile', 'timeFrame': 'Baseline (week 0), week 16', 'description': 'Change from baseline (week 0) in mean of the 7-9-7 point SMPG profile was evaluated after 16 weeks of randomisation. 7-9-7 SMPG point profile was performed on the 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast, 60 minutes after the start of breakfast, before lunch, 60 minutes after the start of lunch, before main evening meal, 60 minutes after the start of main evening meal, and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on the following day. The mean of the 7-9-7-point profile was defined as the area under the curve profile divided by the measurement time, and was calculated using the linear trapezoidal technique. 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 7-9-7-point SMPG for 1-hour PPG (Mean, Breakfast, Lunch, Main Evening Meal)', 'timeFrame': 'Baseline (week 0), week 16', 'description': 'Change from baseline (week 0) in 1-hour PPG (breakfast, lunch, main evening meal and mean over all meals) of the 7-9-7 point SMPG profile was evaluated after 16 weeks of randomisation. 7-9-7 SMPG point profile was performed on the 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast, 60 minutes after the start of breakfast, before lunch, 60 minutes after the start of lunch, before main evening meal, 60 minutes after the start of main evening meal, and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on the following day. Results were derived from the three profiles: post-breakfast, post-lunch, post-main evening meal. 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 7-9-7-point SMPG for PPG Increment (Mean, Breakfast, Lunch, Main Evening Meal)', 'timeFrame': 'Baseline (week 0), week 16', 'description': 'Change from baseline (week 0) in PPG increment of the 7-9-7 point SMPG profile was evaluated after 16 weeks of randomisation. 7-9-7 SMPG point profile was performed on the 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast, 60 minutes after the start of breakfast, before lunch, 60 minutes after the start of lunch, before main evening meal, 60 minutes after the start of main evening meal, and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on the following day. PPG increment for each meal was derived from the 7-point and 9-point profile as the difference between PPG values and the PG value before the meal in each separate profile. 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 7-9-7-point SMPG for Fluctuation in 7-9-7-point Profile: Ratio to Baseline', 'timeFrame': 'Baseline (week 0), week 16', 'description': 'Fluctuation in SMPG profile was the average absolute difference from the mean of the SMPG profile. Change from baseline is represented as ratio to baseline value. 7-9-7 SMPG point profile was performed on the 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast, 60 minutes after the start of breakfast, before lunch, 60 minutes after the start of lunch, before main evening meal, 60 minutes after the start of main evening meal, and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on the following day. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.'}, {'measure': 'Number of Participants Who Achieved HbA1c Less Than (<) 7.0 (Percent [%]) (Yes/No)', 'timeFrame': 'At week 16', 'description': 'Number of participants who achieved HbA1c \\< 7% measured as 53 mmol/mol at week 16 is presented. In the reported data, "Yes" infers the number of participants who have achieved HbA1c values \\< 7% and "No" infers the number of participants who have not achieved HbA1c values \\< 7%. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.'}, {'measure': 'Number of Participants Who Achieved HbA1c <7.0% Without Severe Hypoglycaemia Episodes (Yes/No)', 'timeFrame': 'At week 16', 'description': 'Number of participants who achieved HbA1c \\< 7% (measured as 53 mmol/mol) without severe hypoglycaemia episodes at week 16 is presented. In the reported data, "Yes" infers the number of participants who have achieved HbA1c values \\< 7% without severe hypoglycaemia episodes and "No" infers the number of participants who have not achieved HbA1c values less than the 7%. without severe hypoglycaemia episodes The results are based on the last in-trial value, which included the last available measurement in the in-trial period.'}, {'measure': 'Number of Participants Who Achieved PPG Target (Overall Mean of Daily PPG Measurements in SMPG) for Overall PPG (1-hour) Less Than or Equal (≤) to 7.8 mmol/L (Yes/No)', 'timeFrame': 'At week 16', 'description': 'Number of participants who achieved overall PPG (1-hour) ≤ 7.8 mmol/L measured as 140 milligrams per deciliter (mg/dL) at week 16 is presented. In the reported data, "Yes" infers the number of participants who have achieved overall PPG (1-hour) values ≤ 7.8 mmol/L and "No" infers the number of participants who have not achieved overall PPG (1-hour) values ≤ 7.8 mmol/L. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.'}, {'measure': 'Number of Participants Who Achieved PPG Target (Overall Mean of Daily PPG Measurements in SMPG) for Overall PPG (1-hour) Less Than or Equal (≤) to 7.8 mmol/L Without Severe Hypoglycaemia (Yes/No)', 'timeFrame': 'At week 16', 'description': 'Number of participants who achieved overall PPG (1-hour) ≤ 7.8 mmol/L (measured as 140 mg/dL) without severe hypoglycaemia at week 16 is presented. In the reported data, "Yes" infers the number of participants who have achieved overall PPG (1-hour) values ≤ 7.8 mmol/L without severe hypoglycaemia and "No" infers the number of participants who have not achieved overall PPG (1-hour) values ≤ 7.8 mmol/L without severe hypoglycaemia. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.'}, {'measure': 'Insulin Dose (Units/Day): Total Basal', 'timeFrame': 'At week 16', 'description': 'Total basal insulin dose 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 (Units/Day): Total Bolus', 'timeFrame': 'At week 16', 'description': 'Total bolus insulin dose 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 (Units/Day): Individual Meal Insulin Dose', 'timeFrame': 'At week 16', 'description': 'Individual meal time bolus insulin dose for breakast, lunch and main evening meal 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 (Units/kg/Day): Total Basal', 'timeFrame': 'At week 16', 'description': 'Total basal insulin dose 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 (Units/kg/Day): Total Bolus', 'timeFrame': 'At week 16', 'description': 'Total bolus insulin dose 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 (Units/kg/Day): Individual Meal Insulin Dose', 'timeFrame': 'At week 16', 'description': 'Individual meal time bolus insulin dose for breakast, lunch and main evening meal 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 Treatment Emergent Adverse Events (TEAEs)', 'timeFrame': 'From baseline (week 0) to 16 weeks after randomisation', 'description': 'Number of treatment emergent adverse events were recorded from week 0 to week 16. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of exposure to randomised treatment.'}, {'measure': 'Number of Treatment Emergent Injection Site Reactions', 'timeFrame': 'From baseline (week 0) to 16 weeks after randomisation', 'description': 'Number of treatment emergent injection site reactions were recorded 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 Treatment Emergent Hypoglycaemic Episodes Classified Both According to the American Diabetes Association (ADA) Definition and Novo Nordisk (NN) Definition: Overall', 'timeFrame': 'From baseline (week 0) to 16 weeks after randomisation', 'description': 'ADA classification of hypoglycaemia as follows: 1) Severe: Requiring assistance to actively administer carbohydrate/glucagon/take other corrective actions. 2) Documented symptomatic: PG ≤3.9 mmol/L with symptoms. 3) Asymptomatic: PG ≤3.9 mmol/L without symptoms. 4) Probable symptomatic: No measurement with symptoms. 5) Pseudo-hypoglycaemia: PG \\>3.9 mmol/L with symptoms. 6) Unclassifiable. NN classification of hypoglycaemia as follows: 1) BG confirmed: PG \\<3.1 mmol/L with/without symptoms. 2) Severe or BG confirmed symptomatic: Severe as per ADA and BG confirmed by PG \\<3.1 mmol/L with symptoms. 3) Severe or BG confirmed: Severe as per ADA and BG confirmed by PG \\<3.1 mmol/L with/without symptoms. 4) Unclassifiable. Not able to self-treat-unclassifiable: Not able to self-treat but not classifiable as severe hypoglycaemia.'}, {'measure': 'Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the ADA Definition and NN Definition: Day Time Hypoglycaemic Episodes (00:01-05:59 - Both Inclusive)', 'timeFrame': 'From baseline (week 0) to 16 weeks after randomisation', 'description': 'Number of treatment emergent day time hypoglycaemic episodes as per ADA and NN definitions were evaluated. ADA classification of hypoglycaemia as follows: 1) Severe: Requiring assistance to actively administer carbohydrate/glucagon/take other corrective actions. 2) Documented symptomatic: PG ≤3.9 mmol/L with symptoms. 3) Asymptomatic: PG ≤3.9 mmol/L without symptoms. 4) Probable symptomatic: No measurement with symptoms. 5) Pseudo-hypoglycaemia: PG \\>3.9 mmol/L with symptoms. 6) Unclassifiable. NN classification of hypoglycaemia as follows: 1) BG confirmed: PG \\<3.1 mmol/L with/without symptoms. 2) Severe or BG confirmed symptomatic: Severe as per ADA and BG confirmed by PG \\<3.1 mmol/L with symptoms. 3) Severe or BG confirmed: Severe as per ADA and BG confirmed by PG \\<3.1 mmol/L with/without symptoms. 4) Unclassifiable. Not able to self-treat-unclassifiable: Not able to self-treat but not classifiable as severe hypoglycaemia.'}, {'measure': 'Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the ADA Definition and NN Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Both Inclusive)', 'timeFrame': 'From baseline (week 0) to 16 weeks after randomisation', 'description': 'Number of treatment emergent nocturnal hypoglycaemic episodes as per ADA and NN definitions were evaluated. ADA classification of hypoglycaemia as follows: 1) Severe: Requiring assistance to actively administer carbohydrate/glucagon/take other corrective actions. 2) Documented symptomatic: PG ≤3.9 mmol/L with symptoms. 3) Asymptomatic: PG ≤3.9 mmol/L without symptoms. 4) Probable symptomatic: No measurement with symptoms. 5) Pseudo-hypoglycaemia: PG \\>3.9 mmol/L with symptoms. 6) Unclassifiable. NN classification of hypoglycaemia as follows: 1) BG confirmed: PG \\<3.1 mmol/L with/without symptoms. 2) Severe or BG confirmed symptomatic: Severe as per ADA and BG confirmed by PG \\<3.1 mmol/L with symptoms. 3) Severe or BG confirmed: Severe as per ADA and BG confirmed by PG \\<3.1 mmol/L with/without symptoms. 4) Unclassifiable. Not able to self-treat-unclassifiable: Not able to self-treat but not classifiable as severe hypoglycaemia.'}, {'measure': 'Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the ADA Definition and NN Definition: Hypoglycaemic Episodes From Start of Meal Until 30 Minutes', 'timeFrame': 'From baseline (week 0) to 16 weeks after randomisation', 'description': 'Number of treatment emergent hypoglycaemic episodes as per ADA and NN definitions were evaluated during first 30-mins after start of meal. ADA classification of hypoglycaemia as follows: 1) Severe: Requiring assistance to actively administer carbohydrate/glucagon/take other corrective actions. 2) Documented symptomatic: PG ≤3.9 mmol/L with symptoms. 3) Asymptomatic: PG ≤3.9 mmol/L without symptoms. 4) Probable symptomatic: No measurement with symptoms. 5) Pseudo-hypoglycaemia: PG \\>3.9 mmol/L with symptoms. 6) Unclassifiable. NN classification of hypoglycaemia as follows: 1) BG confirmed: PG \\<3.1 mmol/L with/without symptoms. 2) Severe or BG confirmed symptomatic: Severe as per ADA and BG confirmed by PG \\<3.1 mmol/L with symptoms. 3) Severe or BG confirmed: Severe as per ADA and BG confirmed by PG \\<3.1 mmol/L with/without symptoms. 4) Unclassifiable. Not able to self-treat-unclassifiable: Not able to self-treat but not classifiable as severe hypoglycaemia.'}, {'measure': 'Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the ADA Definition and NN Definition: Hypoglycaemic Episodes From Start of Meal Until 1 Hour', 'timeFrame': 'From baseline (week 0) to 16 weeks after randomisation', 'description': 'Number of treatment emergent hypoglycaemic episodes as per ADA and NN definitions were evaluated during first 1 hour after start of meal. ADA classification of hypoglycaemia as follows: 1) Severe: Requiring assistance to actively administer carbohydrate/glucagon/take other corrective actions. 2) Documented symptomatic: PG ≤3.9 mmol/L with symptoms. 3) Asymptomatic: PG ≤3.9 mmol/L without symptoms. 4) Probable symptomatic: No measurement with symptoms. 5) Pseudo-hypoglycaemia: PG \\>3.9 mmol/L with symptoms. 6) Unclassifiable. NN classification of hypoglycaemia as follows: 1) BG confirmed: PG \\<3.1 mmol/L with/without symptoms. 2) Severe or BG confirmed symptomatic: Severe as per ADA and BG confirmed by PG \\<3.1 mmol/L with symptoms. 3) Severe or BG confirmed: Severe as per ADA and BG confirmed by PG \\<3.1 mmol/L with/without symptoms. 4) Unclassifiable. Not able to self-treat-unclassifiable: Not able to self-treat but not classifiable as severe hypoglycaemia.'}, {'measure': 'Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the ADA Definition and NN Definition: Hypoglycaemic Episodes From Start of Meal Until 2 Hours', 'timeFrame': 'From baseline (week 0) to 16 weeks after randomisation', 'description': 'Number of treatment emergent hypoglycaemic episodes as per ADA and NN definitions were evaluated during first 2 hours after start of meal. ADA classification of hypoglycaemia as follows: 1) Severe: Requiring assistance to actively administer carbohydrate/glucagon/take other corrective actions. 2) Documented symptomatic: PG ≤3.9 mmol/L with symptoms. 3) Asymptomatic: PG ≤3.9 mmol/L without symptoms. 4) Probable symptomatic: No measurement with symptoms. 5) Pseudo-hypoglycaemia: PG \\>3.9 mmol/L with symptoms. 6) Unclassifiable. NN classification of hypoglycaemia as follows: 1) BG confirmed: PG \\<3.1 mmol/L with/without symptoms. 2) Severe or BG confirmed symptomatic: Severe as per ADA and BG confirmed by PG \\<3.1 mmol/L with symptoms. 3) Severe or BG confirmed: Severe as per ADA and BG confirmed by PG \\<3.1 mmol/L with/without symptoms. 4) Unclassifiable. Not able to self-treat-unclassifiable: Not able to self-treat but not classifiable as severe hypoglycaemia.'}, {'measure': 'Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the ADA Definition and NN Definition: Hypoglycaemic Episodes From Start of Meal Until 4 Hours', 'timeFrame': 'From baseline (week 0) to 16 weeks after randomisation', 'description': 'Number of treatment emergent hypoglycaemic episodes as per ADA and NN definitions were evaluated during first 4 hours after start of meal. ADA classification of hypoglycaemia as follows: 1) Severe: Requiring assistance to actively administer carbohydrate/glucagon/take other corrective actions. 2) Documented symptomatic: PG ≤3.9 mmol/L with symptoms. 3) Asymptomatic: PG ≤3.9 mmol/L without symptoms. 4) Probable symptomatic: No measurement with symptoms. 5) Pseudo-hypoglycaemia: PG \\>3.9 mmol/L with symptoms. 6) Unclassifiable. NN classification of hypoglycaemia as follows: 1) BG confirmed: PG \\<3.1 mmol/L with/without symptoms. 2) Severe or BG confirmed symptomatic: Severe as per ADA and BG confirmed by PG \\<3.1 mmol/L with symptoms. 3) Severe or BG confirmed: Severe as per ADA and BG confirmed by PG \\<3.1 mmol/L with/without symptoms. 4) Unclassifiable. Not able to self-treat-unclassifiable: Not able to self-treat but not classifiable as severe hypoglycaemia.'}, {'measure': 'Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the ADA Definition and NN Definition: Hypoglycaemic Episodes From 2 Hours (Exclusive) to 4 Hours (Inclusive) After Start of Meal', 'timeFrame': 'From baseline (week 0) to 16 weeks after randomisation', 'description': 'Number of treatment emergent hypoglycaemic episodes as per ADA and NN definitions were evaluated from 2 hours to 4 hours after start of meal. ADA classification of hypoglycaemia as follows: 1) Severe: Requiring assistance to actively administer carbohydrate/glucagon/take other corrective actions. 2) Documented symptomatic: PG ≤3.9 mmol/L with symptoms. 3) Asymptomatic: PG ≤3.9 mmol/L without symptoms. 4) Probable symptomatic: No measurement with symptoms. 5) Pseudo-hypoglycaemia: PG \\>3.9 mmol/L with symptoms. 6) Unclassifiable. NN classification of hypoglycaemia as follows: 1) BG confirmed: PG \\<3.1 mmol/L with/without symptoms. 2) Severe or BG confirmed symptomatic: Severe as per ADA and BG confirmed by PG \\<3.1 mmol/L with symptoms. 3) Severe or BG confirmed: Severe as per ADA and BG confirmed by PG \\<3.1 mmol/L with/without symptoms. 4) Unclassifiable. Not able to self-treat-unclassifiable: Not able to self-treat but not classifiable as severe hypoglycaemia.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 1', 'Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'Fast-acting insulin aspart (faster aspart) will be tested to see how well it works and if it is safe. The study compares 2 medicines for type 1 and type 2 diabetes - faster aspart (a new medicine) and insulin aspart (a medicine doctors can already prescribe). Participants will either get faster aspart or insulin aspart (NovoRapid®) - which treatment is decided by chance. Both medicines will be taken together with insulin degludec. Participants will need to take 1 injection 4 times every day: 3 injections 0-2 minutes before breakfast, lunch and dinner and 1 injection at the same time every day. All study medicines are provided in pens. A pen is a tool to inject insulin under the skin.The study will last for about 7 months (30 weeks). Participants will have 11 clinic visits and 17 phone contacts with the study doctor. At 8 clinic visits participants will have blood samples taken. At 3 clinic visits participants cannot eat or drink (water is allowed) 8 hours before the visits - at 2 of these visits participants will be asked to drink a liquid meal and to stay at the clinic for about 5 hours. Participants will fill in a diary the last 3 days before the visits/phone contacts. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, age above or equal to 18 years at the time of signing informed consent\n* Diagnosed with Diabetes Mellitus, Type 1 (T1DM) at least or equal to 1 year prior to screening or diagnosed with Diabetes Mellitus, Type 2 (T2DM) at least or equal to 5 years prior to screening\n* Treated with a basal-bolus insulin regimen or a premix insulin regimen at least or equal to 1 year prior to screening. Insulin regimen must be unchanged within 60 days prior to screening. A basal-bolus insulin regimen is defined as basal insulin once or twice daily and bolus insulin taken with meals at least thrice daily. A premix insulin regimen is defined as premix insulin twice or thrice daily\n* For subjects with T1DM: not treated with any oral anti-diabetes drugs (OADs) for at least 90 days prior to screening. For subjects with T2DM: not treated with any OADs or treated with 1-2 OADs within 90 days prior to screening. Allowed OADs are metformin, alpha-glucosidase inhibitor, sodium-glucose co-transporter-2 inhibitors (SGLT2i) and dipeptidyl peptidase-4 inhibitors (DPP4i). Change in OAD and dose prior to screening is allowed.\n* HbA1c 7.5-9.5% (both inclusive) as assessed by central laboratory at screening\n\nExclusion Criteria:\n\n* Any of the following: myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within the past 180 days prior to the day of screening\n* Subjects presently classified as being in New York Heart Association (NYHA) Class IV\n* Planned coronary, carotid or peripheral artery revascularisation known on the day of screening\n* Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening\n* Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or corticosteroids)'}, 'identificationModule': {'nctId': 'NCT04588259', 'briefTitle': 'Research Study to Compare a New Medicine "Fast-acting Insulin Aspart" to Another Medicine "Insulin Aspart" in Chinese People With Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Efficacy and Safety of Fast-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec With or Without Metformin in Adults With Diabetes', 'orgStudyIdInfo': {'id': 'NN1218-4357'}, 'secondaryIdInfos': [{'id': 'U1111-1197-8289', 'type': 'OTHER', 'domain': 'World Health Organization (WHO)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Faster aspart', 'description': '4 daily injections of faster aspart given with insulin degludec and with or without metformin', 'interventionNames': ['Drug: Faster aspart', 'Drug: Insulin degludec']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Insulin aspart', 'description': '4 daily injections of insulin aspart given with insulin degludec and with or without metformin', 'interventionNames': ['Drug: Insulin aspart', 'Drug: Insulin degludec']}], 'interventions': [{'name': 'Faster aspart', 'type': 'DRUG', 'description': 'Administered s.c. (subcutaneously, under the skin) for 16 weeks', 'armGroupLabels': ['Faster aspart']}, {'name': 'Insulin aspart', 'type': 'DRUG', 'description': 'Administered s.c. (subcutaneously, under the skin) for 16 weeks', 'armGroupLabels': ['Insulin aspart']}, {'name': 'Insulin degludec', 'type': 'DRUG', 'description': 'Administered s.c. 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