Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2026-03-03 @ 10:06 AM
Study NCT ID:
NCT02500706
Status:
COMPLETED
Last Update Posted:
2019-06-12
First Post:
2015-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec in Adults With Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061267', 'term': 'Insulin Aspart'}, {'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 Anchor and Disclosure (1452)', 'organization': 'Novo Nordisk A/S'}, 'certainAgreement': {'otherDetails': 'At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Week 0 to week 26 (+7 days)', 'description': 'A 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 randomised treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Faster Aspart (Meal)', 'description': 'Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.', 'otherNumAtRisk': 342, 'deathsNumAtRisk': 342, 'otherNumAffected': 154, 'seriousNumAtRisk': 342, 'deathsNumAffected': 0, 'seriousNumAffected': 20}, {'id': 'EG001', 'title': 'Faster Aspart (Post)', 'description': 'Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.', 'otherNumAtRisk': 341, 'deathsNumAtRisk': 341, 'otherNumAffected': 152, 'seriousNumAtRisk': 341, 'deathsNumAffected': 0, 'seriousNumAffected': 17}, {'id': 'EG002', 'title': 'NovoRapid (Meal)', 'description': 'After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.', 'otherNumAtRisk': 342, 'deathsNumAtRisk': 342, 'otherNumAffected': 161, 'seriousNumAtRisk': 342, 'deathsNumAffected': 0, 'seriousNumAffected': 17}], 'otherEvents': [{'term': 'Blood glucose decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 81, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 341, 'numEvents': 83, 'numAffected': 67}, {'groupId': 'EG002', 'numAtRisk': 342, 'numEvents': 82, 'numAffected': 68}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 22, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 341, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 342, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 38, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 341, 'numEvents': 34, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 342, 'numEvents': 34, 'numAffected': 27}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 101, 'numAffected': 73}, {'groupId': 'EG001', 'numAtRisk': 341, 'numEvents': 100, 'numAffected': 70}, {'groupId': 'EG002', 'numAtRisk': 342, 'numEvents': 118, 'numAffected': 80}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}], 'seriousEvents': [{'term': 'Bladder transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 341, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Blood glucose fluctuation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 341, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 342, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 341, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 341, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 341, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 341, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 341, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 342, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Collagen disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 341, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 341, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Diabetic metabolic decompensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 341, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 342, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Diabetic neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 341, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 341, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 342, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Extradural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 341, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 341, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 341, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 342, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Forearm fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 341, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 341, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 341, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Haemorrhoid operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 341, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 341, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 342, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Hypoglycaemia unawareness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 341, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Hypoglycaemic coma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 341, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 342, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Hypoglycaemic seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 341, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Hypoglycaemic unconsciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 341, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 342, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Inguinal hernia repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 341, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 342, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Intervertebral disc disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 341, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 341, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 342, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Pilonidal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 341, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Polyneuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 341, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Postoperative ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 341, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 341, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 341, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Skull fractured base', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 341, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 341, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Trigger finger', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 341, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Ulna fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 341, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 341, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 342, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Wrong drug administered', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 341, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 342, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in HbA1c 26 Weeks After Randomisation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '341', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart (Meal)', 'description': 'Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG001', 'title': 'Faster Aspart (Post)', 'description': 'Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG002', 'title': 'NovoRapid (Meal)', 'description': 'After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.12', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '0.005', 'spread': '0.64', 'groupId': 'OG001'}, {'value': '-0.09', 'spread': '0.65', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.11', 'ciUpperLimit': '0.07', 'pValueComment': 'p-value from the 2-sided test for treatment difference evaluated at the 5% level', 'groupDescription': 'The endpoint was analysed using an analysis of variance model after multiple imputation assuming treatment according to randomisation. The model includes treatment, region and bolus adjusting method at randomisation as factors, and baseline HbA1c as a covariate.', 'statisticalMethod': 'ANOVA model after multiple imputation', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Stepwise hierarchical testing procedure was applied for confirmatory endpoints:\n\nStep 1: Primary analysis: HbA1c non-inferiority of mealtime faster aspart versus mealtime NovoRapid®/NovoLog®.\n\nNon-inferiority of mealtime faster aspart was considered confirmed if the upper boundary of the two-sided 95% CI was below or equal to 0.4%'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.10', 'ciLowerLimit': '0.004', 'ciUpperLimit': '0.19', 'pValueComment': 'p-value from the 2-sided test for treatment difference evaluated at the 5% level.', 'groupDescription': 'The endpoint was analysed using an analysis of variance model after multiple imputation assuming treatment according to randomisation. The model includes treatment, region and bolus adjusting method at randomisation as factors, and baseline HbA1c as a covariate.', 'statisticalMethod': 'ANOVA model after multiple imputation', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Stepwise hierarchical testing procedure was applied for confirmatory endpoints:\n\nStep 2: HbA1c non-inferiority of postmeal faster aspart versus mealtime NovoRapid®/NovoLog®.\n\nNon-inferiority of postmeal faster aspart was considered confirmed if the upper boundary of the two-sided 95% CI was below or equal to 0.4%'}, {'pValue': '0.633', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.11', 'ciUpperLimit': '0.07', 'pValueComment': 'p-value from the 2-sided test for treatment difference evaluated at the 5% level', 'groupDescription': 'The endpoint was analysed using an analysis of variance model after multiple imputation assuming treatment according to randomisation. The model includes treatment, region and bolus adjusting method at randomisation as factors, and baseline HbA1c as a covariate.', 'statisticalMethod': 'ANOVA model after multiple imputation', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Stepwise hierarchical testing procedure was applied for confirmatory endpoints:\n\nStep 4: HbA1c superiority of mealtime faster aspart versus mealtime NovoRapid®/NovoLog®.\n\nSuperiority was to be confirmed if the upper boundary of the two-sided 95% CI of the mean treatment difference (mealtime faster aspart minus mealtime NovoRapid®/NovoLog®) was below 0%-points.'}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'Change from baseline (week 0) in HbA1c was evaluated after 26 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In-trial period: the observation period from date of randomisation until last trial-related subject-site contact.', 'unitOfMeasure': 'percentage of HbA1c', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on FAS. Number of subjects analysed=subject with data available for HbA1c.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 1-hour Post Prandial Glucose (PPG) Increment 26 Weeks After Randomisation (Meal Test)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '332', 'groupId': 'OG000'}, {'value': '332', 'groupId': 'OG001'}, {'value': '326', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart (Meal)', 'description': 'Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG001', 'title': 'Faster Aspart (Post)', 'description': 'Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG002', 'title': 'NovoRapid (Meal)', 'description': 'After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.13', 'spread': '4.04', 'groupId': 'OG000'}, {'value': '1.04', 'spread': '3.53', 'groupId': 'OG001'}, {'value': '-0.15', 'spread': '3.78', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.90', 'ciLowerLimit': '-1.36', 'ciUpperLimit': '-0.45', 'pValueComment': 'p-value from the 2-sided test for treatment difference evaluated at the 5% level.', 'groupDescription': 'Change from baseline in postprandial glucose increment (meal test) is analysed using an analysis of variance model. The model includes treatment, region and bolus adjusting method at randomisation as factors, and baseline postprandial glucose increment as a covariate.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Stepwise hierarchical testing procedure was applied for confirmatory endpoints:\n\nStep 3: 1-hour postprandial glucose (PPG) increments superiority of mealtime faster aspart versus mealtime NovoRapid®/NovoLog.\n\nSuperiority was confirmed if the upper boundary of the two-sided 95% CI of the mean treatment difference (mealtime faster aspart minus mealtime NovoRapid®/NovoLog®) was below 0.'}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'The 1-hour PPG increment was analysed based on the laboratory-measured values in the meal test, and was derived using the 1-hour PPG measurement minus the pre-prandial plasma glucose (PG). 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': 'Analysis was based on FAS. Number of subjects analysed=subject with data available for 1-hour PPG and pre-prandial PG.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 1,5-anhydroglucitol 26 Weeks After Randomisation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '341', 'groupId': 'OG000'}, {'value': '336', 'groupId': 'OG001'}, {'value': '338', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart (Meal)', 'description': 'Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG001', 'title': 'Faster Aspart (Post)', 'description': 'Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG002', 'title': 'NovoRapid (Meal)', 'description': 'After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.22', 'spread': '2.23', 'groupId': 'OG000'}, {'value': '-0.15', 'spread': '2.10', 'groupId': 'OG001'}, {'value': '0.22', 'spread': '2.25', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.924', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-0.31', 'ciUpperLimit': '0.34', 'pValueComment': 'p-values are from the 2-sided test for treatment difference evaluated at the 5% level.', 'groupDescription': 'Change from baseline in 1,5-anhydroglucitol was analysed using an analysis of variance model after multiple imputation assuming treatment according to randomisation. The model includes treatment, region and bolus adjusting method at randomisation as factors, and baseline 1,5-anhydroglucitol as a covariate.', 'statisticalMethod': 'ANOVA model after multiple imputation', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Stepwise hierarchical testing procedure was applied for confirmatory endpoints:\n\nStep 5: 1,5-anhydroglucitol superiority of mealtime faster aspart versus mealtime NovoRapid®/NovoLog®.\n\nSuperiority was to be confirmed if the lower boundary of the two-sided 95% CI of the mean treatment difference (mealtime faster aspart minus mealtime NovoRapid®/NovoLog®) was above 0.'}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'The results are based on the last in-trial value, which included the last available measurement in the in-trial period.', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on FAS. Number of subjects analysed=subject with data available for 1,5-anhydroglucitol.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose (FPG) 26 Weeks After Randomisation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}, {'value': '336', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart (Meal)', 'description': 'Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG001', 'title': 'Faster Aspart (Post)', 'description': 'Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG002', 'title': 'NovoRapid (Meal)', 'description': 'After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.17', 'spread': '2.94', 'groupId': 'OG000'}, {'value': '0.44', 'spread': '3.29', 'groupId': 'OG001'}, {'value': '0.64', 'spread': '3.35', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26', 'description': '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': 'Analysis was based on FAS. Number of subjects analysed=subject with data available for HbA1c.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0%) 26 Weeks After Randomisation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart (Meal)', 'description': 'Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG001', 'title': 'Faster Aspart (Post)', 'description': 'Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG002', 'title': 'NovoRapid (Meal)', 'description': 'After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '28.7', 'groupId': 'OG000'}, {'value': '28.2', 'groupId': 'OG001'}, {'value': '32.7', 'groupId': 'OG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '71.3', 'groupId': 'OG000'}, {'value': '71.8', 'groupId': 'OG001'}, {'value': '67.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '26 weeks after randomisation', 'description': 'The percentage of subjects who achieved the HbA1c target of \\<7.0% 26 weeks after randomisation. Subjects without an HbA1c measurement at week 26 were treated as non-responders.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on FAS.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia) 26 Weeks After Randomisation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart (Meal)', 'description': 'Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG001', 'title': 'Faster Aspart (Post)', 'description': 'Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG002', 'title': 'NovoRapid (Meal)', 'description': 'After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '25.7', 'groupId': 'OG000'}, {'value': '26.4', 'groupId': 'OG001'}, {'value': '30.4', 'groupId': 'OG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '74.3', 'groupId': 'OG000'}, {'value': '73.6', 'groupId': 'OG001'}, {'value': '69.6', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '26 weeks after randomisation', 'description': 'The percentage of subjects who achieved the HbA1c target of \\<7.0% without severe hypoglycaemia 26 weeks after randomisation. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Subjects without an HbA1c measurement at week 26 were treated as non-responders.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on FAS.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia and Minimal Weight Gain [<3.0%]) 26 Weeks After Randomisation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart (Meal)', 'description': 'Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG001', 'title': 'Faster Aspart (Post)', 'description': 'Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG002', 'title': 'NovoRapid (Meal)', 'description': 'After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '16.4', 'groupId': 'OG000'}, {'value': '17.9', 'groupId': 'OG001'}, {'value': '19.3', 'groupId': 'OG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '83.6', 'groupId': 'OG000'}, {'value': '82.1', 'groupId': 'OG001'}, {'value': '80.7', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '26 weeks after randomisation', 'description': 'The percentage of subjects who achieved the HbA1c target of \\<7.0% without severe hypoglycaemia and with minimal weight gain (defined as less than a 3% increase) 26 weeks after randomisation. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Subjects without an HbA1c measurement at week 26 or without body weight measurement at week 26 were treated as non-responders.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on FAS.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG 26 Weeks After Randomisation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart (Meal)', 'description': 'Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG001', 'title': 'Faster Aspart (Post)', 'description': 'Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG002', 'title': 'NovoRapid (Meal)', 'description': 'After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}], 'classes': [{'title': 'Change in PPG at 30 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '333', 'groupId': 'OG000'}, {'value': '331', 'groupId': 'OG001'}, {'value': '326', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.47', 'spread': '3.58', 'groupId': 'OG000'}, {'value': '1.31', 'spread': '3.52', 'groupId': 'OG001'}, {'value': '0.21', 'spread': '3.78', 'groupId': 'OG002'}]}]}, {'title': 'Change in PPG at 1 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '333', 'groupId': 'OG000'}, {'value': '333', 'groupId': 'OG001'}, {'value': '326', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.05', 'spread': '4.56', 'groupId': 'OG000'}, {'value': '1.39', 'spread': '4.44', 'groupId': 'OG001'}, {'value': '0.20', 'spread': '4.52', 'groupId': 'OG002'}]}]}, {'title': 'Change in PPG at 2 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}, {'value': '333', 'groupId': 'OG001'}, {'value': '323', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.41', 'spread': '5.17', 'groupId': 'OG000'}, {'value': '0.80', 'spread': '5.38', 'groupId': 'OG001'}, {'value': '0.33', 'spread': '5.51', 'groupId': 'OG002'}]}]}, {'title': 'Change in PPG at 3 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '332', 'groupId': 'OG000'}, {'value': '327', 'groupId': 'OG001'}, {'value': '324', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.12', 'spread': '5.20', 'groupId': 'OG000'}, {'value': '0.93', 'spread': '5.06', 'groupId': 'OG001'}, {'value': '0.51', 'spread': '5.33', 'groupId': 'OG002'}]}]}, {'title': 'Change in PPG at 4 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}, {'value': '328', 'groupId': 'OG001'}, {'value': '325', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.005', 'spread': '4.64', 'groupId': 'OG000'}, {'value': '0.83', 'spread': '4.59', 'groupId': 'OG001'}, {'value': '0.53', 'spread': '4.60', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'Laboratory measured PG from the meal test was analysed for 30, 60, 120, 180, and 240 minutes PPG separately. 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': 'Analysis was based on FAS. Number of analysed=subject with data available for PPG at individual timepoints.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG Increment 26 Weeks After Randomisation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart (Meal)', 'description': 'Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG001', 'title': 'Faster Aspart (Post)', 'description': 'Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG002', 'title': 'NovoRapid (Meal)', 'description': 'After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}], 'classes': [{'title': 'Change in PPG increment at 30 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '332', 'groupId': 'OG000'}, {'value': '330', 'groupId': 'OG001'}, {'value': '326', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.55', 'spread': '2.55', 'groupId': 'OG000'}, {'value': '0.94', 'spread': '2.47', 'groupId': 'OG001'}, {'value': '-0.14', 'spread': '2.63', 'groupId': 'OG002'}]}]}, {'title': 'Change in PPG increment at 1 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '332', 'groupId': 'OG000'}, {'value': '332', 'groupId': 'OG001'}, {'value': '326', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.13', 'spread': '4.04', 'groupId': 'OG000'}, {'value': '1.04', 'spread': '3.53', 'groupId': 'OG001'}, {'value': '-0.15', 'spread': '3.78', 'groupId': 'OG002'}]}]}, {'title': 'Change in PPG increment at 2 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '328', 'groupId': 'OG000'}, {'value': '331', 'groupId': 'OG001'}, {'value': '323', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.47', 'spread': '4.74', 'groupId': 'OG000'}, {'value': '0.42', 'spread': '5.01', 'groupId': 'OG001'}, {'value': '-0.01', 'spread': '5.15', 'groupId': 'OG002'}]}]}, {'title': 'Change in PPG increment at 3 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}, {'value': '324', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.20', 'spread': '4.89', 'groupId': 'OG000'}, {'value': '0.55', 'spread': '4.95', 'groupId': 'OG001'}, {'value': '0.11', 'spread': '5.32', 'groupId': 'OG002'}]}]}, {'title': 'Change in PPG increment at 4 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}, {'value': '327', 'groupId': 'OG001'}, {'value': '325', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.10', 'spread': '4.47', 'groupId': 'OG000'}, {'value': '0.45', 'spread': '4.44', 'groupId': 'OG001'}, {'value': '0.16', 'spread': '4.63', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'Laboratory measured PG from the meal test was analysed for 30, 60, 120, 180, and 240 minutes PPG separately. The corresponding PPG increments were derived separately using each PPG measurement minus the pre-prandial PG. 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': 'Analysis was based on FAS. Number of analysed=subject with data available for PPG and pre-prandial PG at individual timepoints.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 7-9-7-point Self-measured Plasma Glucose (SMPG) 26 Weeks After Randomisation: Mean of the 7-9-7-point Profile', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '327', 'groupId': 'OG001'}, {'value': '320', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart (Meal)', 'description': 'Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG001', 'title': 'Faster Aspart (Post)', 'description': 'Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG002', 'title': 'NovoRapid (Meal)', 'description': 'After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.304', 'spread': '1.928', 'groupId': 'OG000'}, {'value': '-0.231', 'spread': '1.846', 'groupId': 'OG001'}, {'value': '-0.309', 'spread': '2.060', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'The subject was instructed to perform a 7-9-7 SMPG point profile 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': 'Analysis was based on FAS. Number of analysed=subject with data available for 7-9-7 point profile.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG (Mean, Breakfast, Lunch, Main Evening Meal)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart (Meal)', 'description': 'Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG001', 'title': 'Faster Aspart (Post)', 'description': 'Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG002', 'title': 'NovoRapid (Meal)', 'description': 'After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}], 'classes': [{'title': 'Change in PPG breakfast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '313', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}, {'value': '316', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.83', 'spread': '3.34', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '3.30', 'groupId': 'OG001'}, {'value': '-0.31', 'spread': '3.18', 'groupId': 'OG002'}]}]}, {'title': 'Change in PPG lunch', 'denoms': [{'units': 'Participants', 'counts': [{'value': '313', 'groupId': 'OG000'}, {'value': '323', 'groupId': 'OG001'}, {'value': '318', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.59', 'spread': '3.04', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '2.98', 'groupId': 'OG001'}, {'value': '-0.33', 'spread': '3.38', 'groupId': 'OG002'}]}]}, {'title': 'Change in PPG main evening meal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}, {'value': '321', 'groupId': 'OG001'}, {'value': '319', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.53', 'spread': '3.55', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '3.56', 'groupId': 'OG001'}, {'value': '-0.14', 'spread': '3.22', 'groupId': 'OG002'}]}]}, {'title': 'Change in PPG all meals', 'denoms': [{'units': 'Participants', 'counts': [{'value': '308', 'groupId': 'OG000'}, {'value': '317', 'groupId': 'OG001'}, {'value': '313', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.65', 'spread': '2.26', 'groupId': 'OG000'}, {'value': '-0.004', 'spread': '2.19', 'groupId': 'OG001'}, {'value': '-0.25', 'spread': '2.33', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'The subject was instructed to perform a 7-9-7 SMPG point profile 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': 'Analysis was based on FAS. Number of analysed=subject with data available data at three profiles: post-breakfast, post-lunch, post-main evening meal.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG Increment (Mean, Breakfast, Lunch, Main Evening Meal)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart (Meal)', 'description': 'Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG001', 'title': 'Faster Aspart (Post)', 'description': 'Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG002', 'title': 'NovoRapid (Meal)', 'description': 'After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}], 'classes': [{'title': 'Change in PPG increment breakfast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '313', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}, {'value': '316', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.14', 'spread': '3.64', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '3.51', 'groupId': 'OG001'}, {'value': '-0.30', 'spread': '3.16', 'groupId': 'OG002'}]}]}, {'title': 'Change in PPG increment lunch', 'denoms': [{'units': 'Participants', 'counts': [{'value': '313', 'groupId': 'OG000'}, {'value': '321', 'groupId': 'OG001'}, {'value': '317', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.67', 'spread': '3.20', 'groupId': 'OG000'}, {'value': '-0.08', 'spread': '3.10', 'groupId': 'OG001'}, {'value': '-0.004', 'spread': '3.31', 'groupId': 'OG002'}]}]}, {'title': 'Change in PPG increment main evening meal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '313', 'groupId': 'OG000'}, {'value': '320', 'groupId': 'OG001'}, {'value': '319', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.29', 'spread': '3.70', 'groupId': 'OG000'}, {'value': '0.34', 'spread': '3.54', 'groupId': 'OG001'}, {'value': '0.26', 'spread': '3.49', 'groupId': 'OG002'}]}]}, {'title': 'Change in PPG increment all meals', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'OG000'}, {'value': '315', 'groupId': 'OG001'}, {'value': '313', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.72', 'spread': '2.06', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '1.98', 'groupId': 'OG001'}, {'value': '-0.02', 'spread': '2.01', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'The subject was instructed to perform a 7-9-7 SMPG point profile 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 (breakfast, lunch, main evening 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': 'Analysis was based on FAS. Number of analysed=subject with data available data for PPG values and the PG value before the meal (breakfast, lunch, main evening meal).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: Fluctuation in 7-9-7-point Profile', 'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'OG000'}, {'value': '335', 'groupId': 'OG001'}, {'value': '331', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart (Meal)', 'description': 'Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG001', 'title': 'Faster Aspart (Post)', 'description': 'Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG002', 'title': 'NovoRapid (Meal)', 'description': 'After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.876', 'spread': '47.490', 'groupId': 'OG000'}, {'value': '0.875', 'spread': '40.293', 'groupId': 'OG001'}, {'value': '0.890', 'spread': '41.978', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'The subject was instructed to perform a 7-9-7 SMPG point profile 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. 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. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on FAS. Number of analysed=subjects who contributed to this analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: Change in the Nocturnal Self-measured Plasma Glucose Measurements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart (Meal)', 'description': 'Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG001', 'title': 'Faster Aspart (Post)', 'description': 'Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG002', 'title': 'NovoRapid (Meal)', 'description': 'After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}], 'classes': [{'title': 'Change in nocturnal increment-bedtime to 04:00', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}, {'value': '188', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.14', 'spread': '5.66', 'groupId': 'OG000'}, {'value': '0.19', 'spread': '6.41', 'groupId': 'OG001'}, {'value': '0.45', 'spread': '5.55', 'groupId': 'OG002'}]}]}, {'title': 'Change in nocturnal increment-bedtime to breakfast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '278', 'groupId': 'OG001'}, {'value': '278', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.86', 'spread': '6.21', 'groupId': 'OG000'}, {'value': '0.93', 'spread': '6.24', 'groupId': 'OG001'}, {'value': '0.33', 'spread': '5.71', 'groupId': 'OG002'}]}]}, {'title': 'Change in nocturnal increment-04:00 to breakfast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}, {'value': '191', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.78', 'spread': '4.95', 'groupId': 'OG000'}, {'value': '1.01', 'spread': '4.12', 'groupId': 'OG001'}, {'value': '-0.02', 'spread': '4.17', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'The subject was instructed to perform 7-9-7 SMPG point profile on 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 following day. Change from baseline in nocturnal PG values (nocturnal increments) was assessed by considering differences between PG values available at bedtime, at 4 a.m and the before breakfast value the following day: (04:00 PG value minus at bedtime PG value), (before breakfast PG value minus at bedtime PG value) and (before breakfast PG value minus 04:00 PG value). Results are based on the last in-trial value (the last available measurement in the in-trial period).', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on FAS. Number of analysed=subjects with available data for nocturnal SMPG measurements.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart (Meal)', 'description': 'Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG001', 'title': 'Faster Aspart (Post)', 'description': 'Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG002', 'title': 'NovoRapid (Meal)', 'description': 'After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '27.8', 'groupId': 'OG000'}, {'value': '19.9', 'groupId': 'OG001'}, {'value': '21.6', 'groupId': 'OG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '72.2', 'groupId': 'OG000'}, {'value': '80.1', 'groupId': 'OG001'}, {'value': '78.4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '26 weeks after randomisation', 'description': 'Percentage of subjects achieving an overall mean 1-hour PPG ≤7.8 mmol/L \\[140 mg/dL\\] 26 weeks after randomisation. Subjects without an overall mean 1-hour PPG at week 26 were treated as non-responders.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on FAS.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L Without Severe Hypoglycaemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart (Meal)', 'description': 'Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG001', 'title': 'Faster Aspart (Post)', 'description': 'Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG002', 'title': 'NovoRapid (Meal)', 'description': 'After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '24.6', 'groupId': 'OG000'}, {'value': '18.8', 'groupId': 'OG001'}, {'value': '20.5', 'groupId': 'OG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '75.4', 'groupId': 'OG000'}, {'value': '81.2', 'groupId': 'OG001'}, {'value': '79.5', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '26 weeks after randomisation', 'description': 'Percentage of subjects achieving an overall mean 1-hour PPG ≤7.8 mmol/L \\[140 mg/dL\\] 26 weeks after randomisation without severe hypoglycaemia. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Subjects without an overall mean 1-hour PPG at week 26 were treated as non-responders.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on FAS.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L and HbA1c <7.0% and Minimal Weight Gain (<3.0%) Without Severe Hypoglycaemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart (Meal)', 'description': 'Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG001', 'title': 'Faster Aspart (Post)', 'description': 'Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG002', 'title': 'NovoRapid (Meal)', 'description': 'After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '7.6', 'groupId': 'OG000'}, {'value': '4.7', 'groupId': 'OG001'}, {'value': '8.2', 'groupId': 'OG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '92.4', 'groupId': 'OG000'}, {'value': '95.3', 'groupId': 'OG001'}, {'value': '91.8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '26 weeks after randomisation', 'description': 'The percentage of subjects who achieved overall mean 1 hour PPG ≤7.8 mmol/L \\[140 mg/dL\\], had HbA1c \\< 7.0% and had minimal weight gain (increase in body weight from baseline \\<3.0%) 26 weeks after randomisation, and without severe hypoglycaemic episodes. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Subjects without an overall mean 1-hour PPG or an HbA1c value or a body weight at week 26 were treated as non-responders.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on FAS.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Lipids-lipoproteins Profile 26 Weeks After Randomisation (Total Cholesterol, High Density Lipoproteins [HDL] Cholesterol, Low Density Lipoproteins [LDL] Cholesterol)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart (Meal)', 'description': 'Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG001', 'title': 'Faster Aspart (Post)', 'description': 'Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG002', 'title': 'NovoRapid (Meal)', 'description': 'After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}], 'classes': [{'title': 'HDL cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}, {'value': '341', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.981', 'spread': '16.200', 'groupId': 'OG000'}, {'value': '0.998', 'spread': '17.283', 'groupId': 'OG001'}, {'value': '0.999', 'spread': '33.056', 'groupId': 'OG002'}]}]}, {'title': 'LDL cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}, {'value': '341', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.025', 'spread': '20.067', 'groupId': 'OG000'}, {'value': '1.053', 'spread': '22.465', 'groupId': 'OG001'}, {'value': '1.062', 'spread': '215.570', 'groupId': 'OG002'}]}]}, {'title': 'Total cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}, {'value': '341', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.002', 'spread': '14.561', 'groupId': 'OG000'}, {'value': '1.030', 'spread': '15.789', 'groupId': 'OG001'}, {'value': '1.020', 'spread': '15.891', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'Change from baseline in HDL cholesterol, LDL cholesterol and total cholesterol 26 weeks after randomization are represented as ratio to baseline values. The results are based on the last in-trial value (the last available measurement in the in-trial period).', 'unitOfMeasure': 'ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on FAS. Number analysed=number of subjects with available data for individual lipid parameter.'}, {'type': 'SECONDARY', 'title': 'Insulin Dose (Basal Insulin Dose, Total and Individual Meal Insulin Dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart (Meal)', 'description': 'Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG001', 'title': 'Faster Aspart (Post)', 'description': 'Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG002', 'title': 'NovoRapid (Meal)', 'description': 'After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}], 'classes': [{'title': 'Daily bolus insulin dose: week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '336', 'groupId': 'OG001'}, {'value': '335', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '25.5', 'spread': '15.4', 'groupId': 'OG000'}, {'value': '25.4', 'spread': '14.3', 'groupId': 'OG001'}, {'value': '26.6', 'spread': '14.8', 'groupId': 'OG002'}]}]}, {'title': 'Daily bolus insulin dose: Last on-treatment value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '341', 'groupId': 'OG000'}, {'value': '337', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '31.1', 'spread': '19.4', 'groupId': 'OG000'}, {'value': '30.5', 'spread': '18.9', 'groupId': 'OG001'}, {'value': '33.5', 'spread': '22.5', 'groupId': 'OG002'}]}]}, {'title': 'Daily basal insulin dose: week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '339', 'groupId': 'OG001'}, {'value': '339', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '25.3', 'spread': '14.5', 'groupId': 'OG000'}, {'value': '26.7', 'spread': '15.6', 'groupId': 'OG001'}, {'value': '26.2', 'spread': '15.0', 'groupId': 'OG002'}]}]}, {'title': 'Daily basal insulin dose: Last on-treatment value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '339', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '26.7', 'spread': '16.6', 'groupId': 'OG000'}, {'value': '27.3', 'spread': '16.8', 'groupId': 'OG001'}, {'value': '27.2', 'spread': '17.3', 'groupId': 'OG002'}]}]}, {'title': 'Total daily insulin dose: week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '335', 'groupId': 'OG001'}, {'value': '335', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '50.8', 'spread': '26.1', 'groupId': 'OG000'}, {'value': '52.2', 'spread': '25.2', 'groupId': 'OG001'}, {'value': '53.1', 'spread': '25.9', 'groupId': 'OG002'}]}]}, {'title': 'Total daily insulin dose: Last on-treatment value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '341', 'groupId': 'OG000'}, {'value': '336', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '57.7', 'spread': '31.4', 'groupId': 'OG000'}, {'value': '57.8', 'spread': '30.2', 'groupId': 'OG001'}, {'value': '60.4', 'spread': '34.0', 'groupId': 'OG002'}]}]}, {'title': 'Daily breakfast bolus insulin dose: Last value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '341', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.8', 'spread': '6.2', 'groupId': 'OG000'}, {'value': '8.6', 'spread': '6.0', 'groupId': 'OG001'}, {'value': '9.5', 'spread': '7.7', 'groupId': 'OG002'}]}]}, {'title': 'Daily lunch bolus insulin dose: Last value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10.5', 'spread': '7.0', 'groupId': 'OG000'}, {'value': '10.3', 'spread': '6.9', 'groupId': 'OG001'}, {'value': '11.2', 'spread': '7.6', 'groupId': 'OG002'}]}]}, {'title': 'Daily main evening meal bolus insulin: Last value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '11.9', 'spread': '7.7', 'groupId': 'OG000'}, {'value': '11.6', 'spread': '7.4', 'groupId': 'OG001'}, {'value': '12.7', 'spread': '9.1', 'groupId': 'OG002'}]}]}, {'title': 'Daily other bolus insulin dose: Last value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}, {'value': '153', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.7', 'spread': '5.1', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '3.5', 'groupId': 'OG001'}, {'value': '4.2', 'spread': '3.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'The insulin doses were summarised descriptively at week 0 and week 26 both by meal type and as total daily dose (total daily and separately for each mealtime dose). Week 26 results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.', 'unitOfMeasure': 'Units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on safety analysis set (all subjects receiving at least one dose of the investigational product or its comparator). Number of subjects analysed=subjects with available data for specified categories.'}, {'type': 'SECONDARY', 'title': 'Number of Treatment Emergent Adverse Events During 26 Weeks After Randomisation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart (Meal)', 'description': 'Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG001', 'title': 'Faster Aspart (Post)', 'description': 'Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG002', 'title': 'NovoRapid (Meal)', 'description': 'After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '649', 'groupId': 'OG000'}, {'value': '656', 'groupId': 'OG001'}, {'value': '627', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to week 26 (+7 days)', 'description': 'A treatment emergent adverse event (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 randomised treatment.', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on SAS.'}, {'type': 'SECONDARY', 'title': 'Number of Treatment-emergent Injection Site Reactions During the 26 Weeks After Randomisation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart (Meal)', 'description': 'Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG001', 'title': 'Faster Aspart (Post)', 'description': 'Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG002', 'title': 'NovoRapid (Meal)', 'description': 'After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to week 26 (+7 days)', 'description': 'A treatment emergent event 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 randomised treatment.', 'unitOfMeasure': 'Injection site reactions', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on SAS.'}, {'type': 'SECONDARY', 'title': 'Number of Hypoglycaemic Episodes Classified Both According to the American Diabetes Association (ADA) Definition and Novo Nordisk (NN) Definition During 26 Weeks After Randomisation: Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart (Meal)', 'description': 'Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG001', 'title': 'Faster Aspart (Post)', 'description': 'Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG002', 'title': 'NovoRapid (Meal)', 'description': 'After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '15760', 'groupId': 'OG000'}, {'value': '16579', 'groupId': 'OG001'}, {'value': '16520', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to week 26 (+1 day)', 'description': 'ADA classification includes following criteria: Severe,Documented symptomatic,Asymptomatic,Probable symptomatic,Pseudo-hypoglycaemia.\n\nNN Classification:\n\n* Severe:same as per ADA classification\n* Symptomatic blood glucose (BG) confirmed: PG\\<3.1 mmol/L with symptoms consistent with hypoglycaemia\n* Asymptomatic BG confirmed:PG\\<3.1 mmol/L without symptoms consistent with hypoglycaemia\n* Severe or BG confirmed symptomatic:severe according to ADA classification or BG confirmed by PG\\<3.1 mmol/L with symptoms consistent with hypoglycaemia\n* BG confirmed:PG\\<3.1 mmol/L with or without symptoms consistent with hypoglycaemia\n* Severe or BG confirmed:severe according to ADA classification or BG confirmed by PG\\<3.1 mmol/L with or without symptoms consistent with hypoglycaemia\n* Unclassifiable Results represent total number of hypoglycaemic episodes. Treatment emergent episode: an event that has onset up to 1 day after last day of randomised treatment and excluding events occurring in run-in period.', 'unitOfMeasure': 'hypoglycaemic episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on SAS.'}, {'type': 'SECONDARY', 'title': 'Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: Daytime and Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart (Meal)', 'description': 'Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG001', 'title': 'Faster Aspart (Post)', 'description': 'Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG002', 'title': 'NovoRapid (Meal)', 'description': 'After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}], 'classes': [{'title': 'Daytime hypoglycaemic episodes', 'categories': [{'measurements': [{'value': '14570', 'groupId': 'OG000'}, {'value': '15379', 'groupId': 'OG001'}, {'value': '15257', 'groupId': 'OG002'}]}]}, {'title': 'Nocturnal hypoglycaemic episodes', 'categories': [{'measurements': [{'value': '1190', 'groupId': 'OG000'}, {'value': '1200', 'groupId': 'OG001'}, {'value': '1263', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to week 26 (+1 day)', 'description': 'ADA classification includes following criteria: Severe, Documented symptomatic, Asymptomatic, Probable symptomatic, Pseudo-hypoglycaemia.\n\nNN Classification:\n\n* Severe: same as per ADA classification\n* Symptomatic BG confirmed: PG\\<3.1 mmol/L with symptoms consistent with hypoglycaemia\n* Asymptomatic BG confirmed: PG\\<3.1 mmol/L without symptoms consistent with hypoglycaemia\n* Severe or BG confirmed symptomatic: severe according to the ADA classification or BG confirmed by PG\\<3.1 mmol/Lwith symptoms consistent with hypoglycaemia\n* BG confirmed: PG\\<3.1 mmol/L with or without symptoms consistent with hypoglycaemia\n* Severe or BG confirmed: severe according to the ADA classification or BG confirmed by PG\\<3.1 mmol/L with or without symptoms consistent with hypoglycaemia\n* Unclassifiable Results represent total number of hypoglycaemic episodes. Nocturnal hypoglycaemic episodes were episodes occurring between 00:01 and 05:59 both inclusive.', 'unitOfMeasure': 'hypoglycaemic episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on SAS.'}, {'type': 'SECONDARY', 'title': 'Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: From Start of Meal Until 1,2, 4 Hours and From 2 Hours (Exclusive) to 4 Hours (Inclusive) After Start of Meal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart (Meal)', 'description': 'Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG001', 'title': 'Faster Aspart (Post)', 'description': 'Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG002', 'title': 'NovoRapid (Meal)', 'description': 'After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}], 'classes': [{'title': 'Within 1 hour after meal', 'categories': [{'measurements': [{'value': '624', 'groupId': 'OG000'}, {'value': '614', 'groupId': 'OG001'}, {'value': '459', 'groupId': 'OG002'}]}]}, {'title': 'Within 2 hours after meal', 'categories': [{'measurements': [{'value': '1314', 'groupId': 'OG000'}, {'value': '1470', 'groupId': 'OG001'}, {'value': '1224', 'groupId': 'OG002'}]}]}, {'title': 'Within 4 hours after meal', 'categories': [{'measurements': [{'value': '3920', 'groupId': 'OG000'}, {'value': '4794', 'groupId': 'OG001'}, {'value': '4129', 'groupId': 'OG002'}]}]}, {'title': 'Between 1 (exclusive) to 2 hours (inclusive)', 'categories': [{'measurements': [{'value': '690', 'groupId': 'OG000'}, {'value': '856', 'groupId': 'OG001'}, {'value': '765', 'groupId': 'OG002'}]}]}, {'title': 'Between 2 (exclusive) to 3 hours (inclusive)', 'categories': [{'measurements': [{'value': '1236', 'groupId': 'OG000'}, {'value': '1634', 'groupId': 'OG001'}, {'value': '1302', 'groupId': 'OG002'}]}]}, {'title': 'Between 2 (exclusive) to 4 hours (inclusive)', 'categories': [{'measurements': [{'value': '2606', 'groupId': 'OG000'}, {'value': '3324', 'groupId': 'OG001'}, {'value': '2905', 'groupId': 'OG002'}]}]}, {'title': 'Between 3 (exclusive) to 4 hours (inclusive) hours', 'categories': [{'measurements': [{'value': '1370', 'groupId': 'OG000'}, {'value': '1690', 'groupId': 'OG001'}, {'value': '1603', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to week 26 (+1 day)', 'description': 'ADA classification includes following criteria: Severe, Documented symptomatic, Asymptomatic, Probable symptomatic, Pseudo-hypoglycaemia.\n\nNN Classification:\n\n* Severe: same as per ADA classification\n* Symptomatic BG confirmed: PG\\<3.1 mmol/L with symptoms consistent with hypoglycaemia\n* Asymptomatic BG confirmed: PG\\<3.1 mmol/L without symptoms consistent with hypoglycaemia\n* Severe or BG confirmed symptomatic: severe according to the ADA classification or BG confirmed by PG\\<3.1 mmol/Lwith symptoms consistent with hypoglycaemia\n* BG confirmed: PG\\<3.1 mmol/L with or without symptoms consistent with hypoglycaemia\n* Severe or BG confirmed: severe according to the ADA classification or BG confirmed by PG\\<3.1 mmol/L with or without symptoms consistent with hypoglycaemia\n* Unclassifiable Results represent total number of hypoglycaemic episodes related to meals.', 'unitOfMeasure': 'hypoglycaemic episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on SAS.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart (Meal)', 'description': 'Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG001', 'title': 'Faster Aspart (Post)', 'description': 'Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG002', 'title': 'NovoRapid (Meal)', 'description': 'After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}], 'classes': [{'title': 'Cardiovascular system - Week 0: Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '97.4', 'groupId': 'OG000'}, {'value': '98.8', 'groupId': 'OG001'}, {'value': '97.7', 'groupId': 'OG002'}]}]}, {'title': 'Cardiovascular system - Week 0: Abn, NCS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000'}, {'value': '0.9', 'groupId': 'OG001'}, {'value': '2.0', 'groupId': 'OG002'}]}]}, {'title': 'Cardiovascular system - Week 0: Abn, CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.3', 'groupId': 'OG001'}, {'value': '0.3', 'groupId': 'OG002'}]}]}, {'title': 'Cardiovascular system - Last value: Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '97.4', 'groupId': 'OG000'}, {'value': '98.8', 'groupId': 'OG001'}, {'value': '97.9', 'groupId': 'OG002'}]}]}, {'title': 'Cardiovascular system - Last value: Abn, NCS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000'}, {'value': '0.9', 'groupId': 'OG001'}, {'value': '1.8', 'groupId': 'OG002'}]}]}, {'title': 'Cardiovascular system - Last value: Abn, CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.3', 'groupId': 'OG001'}, {'value': '0.3', 'groupId': 'OG002'}]}]}, {'title': 'Nervous system - Week 0: Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '83.9', 'groupId': 'OG000'}, {'value': '86.8', 'groupId': 'OG001'}, {'value': '86.3', 'groupId': 'OG002'}]}]}, {'title': 'Nervous system - Week 0: Abn, NCS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '15.5', 'groupId': 'OG000'}, {'value': '12.9', 'groupId': 'OG001'}, {'value': '13.2', 'groupId': 'OG002'}]}]}, {'title': 'Nervous system - Week 0: Abn, CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}, {'value': '0.3', 'groupId': 'OG001'}, {'value': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'Nervous system - Last value: Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '83.8', 'groupId': 'OG000'}, {'value': '87.1', 'groupId': 'OG001'}, {'value': '86.8', 'groupId': 'OG002'}]}]}, {'title': 'Nervous system - Last value: Abn, NCS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '15.6', 'groupId': 'OG000'}, {'value': '12.9', 'groupId': 'OG001'}, {'value': '12.4', 'groupId': 'OG002'}]}]}, {'title': 'Nervous system - Last value: Abn, CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.9', 'groupId': 'OG002'}]}]}, {'title': 'Gastrointestinal system-week 0: Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '99.7', 'groupId': 'OG000'}, {'value': '98.8', 'groupId': 'OG001'}, {'value': '98.2', 'groupId': 'OG002'}]}]}, {'title': 'Gastrointestinal system-week 0: Abn, NCS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}, {'value': '0.9', 'groupId': 'OG001'}, {'value': '0.9', 'groupId': 'OG002'}]}]}, {'title': 'Gastrointestinal system-week 0: Abn, CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.3', 'groupId': 'OG001'}, {'value': '0.9', 'groupId': 'OG002'}]}]}, {'title': 'Gastrointestinal system-Last value: Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '99.1', 'groupId': 'OG000'}, {'value': '97.9', 'groupId': 'OG001'}, {'value': '98.5', 'groupId': 'OG002'}]}]}, {'title': 'Gastrointestinal system-Last value: Abn, NCS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '1.2', 'groupId': 'OG001'}, {'value': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'Gastrointestinal system-Last value: Abn, CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.9', 'groupId': 'OG001'}, {'value': '0.9', 'groupId': 'OG002'}]}]}, {'title': 'Head,ears,eyes,nose,throat,neck:week 0-Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '95.0', 'groupId': 'OG000'}, {'value': '95.6', 'groupId': 'OG001'}, {'value': '93.3', 'groupId': 'OG002'}]}]}, {'title': 'Head,ear,eye,nose,throat,neck-week 0:Abn,NCS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000'}, {'value': '3.8', 'groupId': 'OG001'}, {'value': '5.8', 'groupId': 'OG002'}]}]}, {'title': 'Head,ears,eyes,nose,throat,neck-week 0:Abn,CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.6', 'groupId': 'OG001'}, {'value': '0.9', 'groupId': 'OG002'}]}]}, {'title': 'Head,ears,eyes,nose,throat,neck-Last value:Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '95.3', 'groupId': 'OG000'}, {'value': '92.9', 'groupId': 'OG001'}, {'value': '94.1', 'groupId': 'OG002'}]}]}, {'title': 'Head,ear,eye,nose,throat,neck-Last value:Abn,NCS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}, {'value': '6.2', 'groupId': 'OG001'}, {'value': '4.4', 'groupId': 'OG002'}]}]}, {'title': 'Head,ear,eye,nose,throat,neck-Last value:Abn,CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.9', 'groupId': 'OG001'}, {'value': '1.5', 'groupId': 'OG002'}]}]}, {'title': 'Musculoskeletal system-week 0: Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '95.9', 'groupId': 'OG000'}, {'value': '97.1', 'groupId': 'OG001'}, {'value': '96.2', 'groupId': 'OG002'}]}]}, {'title': 'Musculoskeletal system-week 0: Abn, NCS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000'}, {'value': '2.9', 'groupId': 'OG001'}, {'value': '3.5', 'groupId': 'OG002'}]}]}, {'title': 'Musculoskeletal system-week 0: Abn, CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.3', 'groupId': 'OG002'}]}]}, {'title': 'Musculoskeletal system-Last value: Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '96.8', 'groupId': 'OG000'}, {'value': '97.4', 'groupId': 'OG001'}, {'value': '95.3', 'groupId': 'OG002'}]}]}, {'title': 'Musculoskeletal system-Last value: Abn, NCS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000'}, {'value': '2.6', 'groupId': 'OG001'}, {'value': '3.8', 'groupId': 'OG002'}]}]}, {'title': 'Musculoskeletal system-Last value: Abn, CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.9', 'groupId': 'OG002'}]}]}, {'title': 'Respiratory system-week 0: Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '99.4', 'groupId': 'OG000'}, {'value': '99.4', 'groupId': 'OG001'}, {'value': '99.1', 'groupId': 'OG002'}]}]}, {'title': 'Respiratory system-week 0: Abn, NCS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}, {'value': '0.3', 'groupId': 'OG001'}, {'value': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'Respiratory system-week 0: Abn, CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.3', 'groupId': 'OG001'}, {'value': '0.3', 'groupId': 'OG002'}]}]}, {'title': 'Respiratory system-Last value: Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '99.7', 'groupId': 'OG000'}, {'value': '99.4', 'groupId': 'OG001'}, {'value': '99.4', 'groupId': 'OG002'}]}]}, {'title': 'Respiratory system-Last value: Abn, NCS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}, {'value': '0.3', 'groupId': 'OG001'}, {'value': '0.3', 'groupId': 'OG002'}]}]}, {'title': 'Respiratory system-Last value: Abn, CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.3', 'groupId': 'OG001'}, {'value': '0.3', 'groupId': 'OG002'}]}]}, {'title': 'Skin-week 0: Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '91.5', 'groupId': 'OG000'}, {'value': '89.7', 'groupId': 'OG001'}, {'value': '91.5', 'groupId': 'OG002'}]}]}, {'title': 'Skin-week 0: Abn, NCS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.3', 'groupId': 'OG000'}, {'value': '8.8', 'groupId': 'OG001'}, {'value': '7.9', 'groupId': 'OG002'}]}]}, {'title': 'Skin-week 0: Abn, CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}, {'value': '1.5', 'groupId': 'OG001'}, {'value': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'Skin-Last value: Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '91.5', 'groupId': 'OG000'}, {'value': '91.5', 'groupId': 'OG001'}, {'value': '92.4', 'groupId': 'OG002'}]}]}, {'title': 'Skin-Last value: Abn, NCS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.6', 'groupId': 'OG000'}, {'value': '6.2', 'groupId': 'OG001'}, {'value': '6.5', 'groupId': 'OG002'}]}]}, {'title': 'Skin-Last value: Abn, CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '2.4', 'groupId': 'OG001'}, {'value': '1.2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0, week 26', 'description': "The physical examination parameters included head, ears, eyes, nose, throat, neck; respiratory system; cardiovascular system; gastrointestinal system including mouth; musculoskeletal system; central and peripheral nervous system; and skin. The examinations were measured as 'normal', 'abnormal, not clinically significant' (Abn, NCS) or 'abnormal, clinically significant' (Abn, CS). Reported results are percentage of subjects with 'normal', 'Abn, NCS' and 'Abn, CS' physical examinations at week 0 and week 26. Week 26 results are based on the last on-treatment value (last value), which included the last available measurement in the on-treatment period.", 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on SAS. Number analysed=number of subjects with available data for physical examinations at specified timepoints.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Blood Pressure 26 Weeks After Randomisation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart (Meal)', 'description': 'Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG001', 'title': 'Faster Aspart (Post)', 'description': 'Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG002', 'title': 'NovoRapid (Meal)', 'description': 'After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}], 'classes': [{'title': 'Diastolic blood pressure', 'categories': [{'measurements': [{'value': '0.5', 'spread': '8.3', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '7.8', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '7.9', 'groupId': 'OG002'}]}]}, {'title': 'Systolic blood pressure', 'categories': [{'measurements': [{'value': '0.6', 'spread': '12.5', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '10.8', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '12.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'Change from baseline in systolic blood pressure and diastolic blood pressure 26 weeks after randomisation. Results are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on SAS. Number of subjects analysed=subjects with available data for blood pressure'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pulse 26 Weeks After Randomisation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart (Meal)', 'description': 'Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG001', 'title': 'Faster Aspart (Post)', 'description': 'Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG002', 'title': 'NovoRapid (Meal)', 'description': 'After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '8.8', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '9.3', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '8.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'Results are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.', 'unitOfMeasure': 'beats/minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on SAS. Number of subjects analysed=subjects with available data for pulse.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Clinical Evaluation (Electrocardiogram) 26 Weeks After Randomisation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart (Meal)', 'description': 'Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG001', 'title': 'Faster Aspart (Post)', 'description': 'Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG002', 'title': 'NovoRapid (Meal)', 'description': 'After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}], 'classes': [{'title': 'Week 0: Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '80.7', 'groupId': 'OG000'}, {'value': '81.8', 'groupId': 'OG001'}, {'value': '84.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 0: Abn, NCS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '19.3', 'groupId': 'OG000'}, {'value': '17.6', 'groupId': 'OG001'}, {'value': '15.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 0: Abn, CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.6', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Last on-treatment value: Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}, {'value': '333', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '80.8', 'groupId': 'OG000'}, {'value': '84.0', 'groupId': 'OG001'}, {'value': '82.3', 'groupId': 'OG002'}]}]}, {'title': 'Last on-treatment value: Abn, NCS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}, {'value': '333', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '19.2', 'groupId': 'OG000'}, {'value': '15.1', 'groupId': 'OG001'}, {'value': '17.1', 'groupId': 'OG002'}]}]}, {'title': 'Last on-treatment value: Abn, CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}, {'value': '333', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.9', 'groupId': 'OG001'}, {'value': '0.6', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0, week 26', 'description': "The electrocardiogram was interpreted by the investigator into following categories: Normal; Abn, NCS; Abnormal, CS. Reported results are percentage of subjects with 'normal', 'Abn, NCS' and 'Abn, CS' physical examinations at week 0 and week 26. Week 26 data are based on the last on-treatment value which contains the last available measurement in the on-treatment period.", 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on SAS. Number analysed=number of subjects with available data for electrocardiogram at specified timepoints.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Clinical Evaluation (Fundoscopy/Fundus Photography) 26 Weeks After Randomisation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart (Meal)', 'description': 'Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG001', 'title': 'Faster Aspart (Post)', 'description': 'Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG002', 'title': 'NovoRapid (Meal)', 'description': 'After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}], 'classes': [{'title': 'Left eye-Week 0: Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '65.8', 'groupId': 'OG000'}, {'value': '68.0', 'groupId': 'OG001'}, {'value': '69.3', 'groupId': 'OG002'}]}]}, {'title': 'Left eye-Week 0: Abn, NCS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '26.9', 'groupId': 'OG000'}, {'value': '23.5', 'groupId': 'OG001'}, {'value': '23.4', 'groupId': 'OG002'}]}]}, {'title': 'Left eye-Week 0: Abn, CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.3', 'groupId': 'OG000'}, {'value': '8.5', 'groupId': 'OG001'}, {'value': '7.3', 'groupId': 'OG002'}]}]}, {'title': 'Left eye-Last on-treatment value: Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '333', 'groupId': 'OG000'}, {'value': '333', 'groupId': 'OG001'}, {'value': '332', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '62.5', 'groupId': 'OG000'}, {'value': '69.4', 'groupId': 'OG001'}, {'value': '69.3', 'groupId': 'OG002'}]}]}, {'title': 'Left eye-Last on-treatment value: Abn, NCS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '333', 'groupId': 'OG000'}, {'value': '333', 'groupId': 'OG001'}, {'value': '332', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '29.7', 'groupId': 'OG000'}, {'value': '21.0', 'groupId': 'OG001'}, {'value': '21.1', 'groupId': 'OG002'}]}]}, {'title': 'Left eye-Last on-treatment value: Abn, CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '333', 'groupId': 'OG000'}, {'value': '333', 'groupId': 'OG001'}, {'value': '332', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.8', 'groupId': 'OG000'}, {'value': '9.6', 'groupId': 'OG001'}, {'value': '9.6', 'groupId': 'OG002'}]}]}, {'title': 'Right eye-Week 0: Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '65.2', 'groupId': 'OG000'}, {'value': '68.9', 'groupId': 'OG001'}, {'value': '67.0', 'groupId': 'OG002'}]}]}, {'title': 'Right eye-Week 0: Abn, NCS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '27.8', 'groupId': 'OG000'}, {'value': '22.3', 'groupId': 'OG001'}, {'value': '25.4', 'groupId': 'OG002'}]}]}, {'title': 'Right eye-Week 0: Abn, CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000'}, {'value': '8.8', 'groupId': 'OG001'}, {'value': '7.6', 'groupId': 'OG002'}]}]}, {'title': 'Right eye-Last on-treatment value: Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '333', 'groupId': 'OG000'}, {'value': '333', 'groupId': 'OG001'}, {'value': '332', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '64.0', 'groupId': 'OG000'}, {'value': '67.9', 'groupId': 'OG001'}, {'value': '68.7', 'groupId': 'OG002'}]}]}, {'title': 'Right eye-Last on-treatment value: Abn, NCS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '333', 'groupId': 'OG000'}, {'value': '333', 'groupId': 'OG001'}, {'value': '332', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '29.1', 'groupId': 'OG000'}, {'value': '22.5', 'groupId': 'OG001'}, {'value': '22.6', 'groupId': 'OG002'}]}]}, {'title': 'Right eye-Last on-treatment value: Abn, CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '333', 'groupId': 'OG000'}, {'value': '333', 'groupId': 'OG001'}, {'value': '332', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.9', 'groupId': 'OG000'}, {'value': '9.6', 'groupId': 'OG001'}, {'value': '8.7', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0, week 26', 'description': "The result of the fundus photography/dilated fundoscopy was interpreted by the investigator into following categories: Normal; Abn, NCS; Abnormal, CS. Reported results are percentage of subjects with 'normal', 'Abn, NCS' and 'Abn, CS' fundoscopy/fundus photography results at week 0 and week 26. Week 26 data are based on the last on-treatment value which contains the last available measurement in the on-treatment period.", 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on SAS. Number analysed=number of subjects with available data for fundoscopy/fundus photography at specified timepoints.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Erythrocytes 26 Weeks After Randomisation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart (Meal)', 'description': 'Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG001', 'title': 'Faster Aspart (Post)', 'description': 'Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG002', 'title': 'NovoRapid (Meal)', 'description': 'After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.26', 'groupId': 'OG001'}, {'value': '-0.02', 'spread': '0.26', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.', 'unitOfMeasure': 'number of erythrocytes 10^12/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for erythrocytes measurement.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Haematocrit 26 Weeks After Randomisation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart (Meal)', 'description': 'Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG001', 'title': 'Faster Aspart (Post)', 'description': 'Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG002', 'title': 'NovoRapid (Meal)', 'description': 'After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.48', 'spread': '2.58', 'groupId': 'OG000'}, {'value': '-0.52', 'spread': '2.41', 'groupId': 'OG001'}, {'value': '-0.57', 'spread': '2.45', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.', 'unitOfMeasure': 'percentage of red blood cells in blood', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for haematocrit measurement.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Haemoglobin 26 Weeks After Randomisation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart (Meal)', 'description': 'Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG001', 'title': 'Faster Aspart (Post)', 'description': 'Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG002', 'title': 'NovoRapid (Meal)', 'description': 'After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.46', 'groupId': 'OG001'}, {'value': '-0.05', 'spread': '0.50', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for haemoglobin measurement.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Leukocytes 26 Weeks After Randomisation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart (Meal)', 'description': 'Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG001', 'title': 'Faster Aspart (Post)', 'description': 'Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG002', 'title': 'NovoRapid (Meal)', 'description': 'After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.17', 'spread': '1.63', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '1.52', 'groupId': 'OG001'}, {'value': '-0.01', 'spread': '1.46', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.', 'unitOfMeasure': 'Number of leukocytes 10^9/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for leukocytes measurement.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Thrombocytes 26 Weeks After Randomisation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '339', 'groupId': 'OG001'}, {'value': '339', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart (Meal)', 'description': 'Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG001', 'title': 'Faster Aspart (Post)', 'description': 'Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG002', 'title': 'NovoRapid (Meal)', 'description': 'After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.7', 'spread': '40.0', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '36.3', 'groupId': 'OG001'}, {'value': '-1.8', 'spread': '33.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.', 'unitOfMeasure': 'Number of thrombocytes 10^9/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for thrombocytes measurement.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Alanine Aminotransferase 26 Weeks After Randomisation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '339', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart (Meal)', 'description': 'Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG001', 'title': 'Faster Aspart (Post)', 'description': 'Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG002', 'title': 'NovoRapid (Meal)', 'description': 'After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'spread': '10.1', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '9.0', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '11.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for alanine aminotransferase measurement.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Albumin 26 Weeks After Randomisation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '339', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart (Meal)', 'description': 'Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG001', 'title': 'Faster Aspart (Post)', 'description': 'Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG002', 'title': 'NovoRapid (Meal)', 'description': 'After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '-0.05', 'spread': '0.25', 'groupId': 'OG001'}, {'value': '-0.03', 'spread': '0.25', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for albumin measurement.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Alkaline Phosphatase 26 Weeks After Randomisation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '339', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart (Meal)', 'description': 'Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG001', 'title': 'Faster Aspart (Post)', 'description': 'Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG002', 'title': 'NovoRapid (Meal)', 'description': 'After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'spread': '18.9', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '12.3', 'groupId': 'OG001'}, {'value': '-0.2', 'spread': '14.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for alkaline phosphatase measurement.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Aspartate Aminotransferase 26 Weeks After Randomisation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '339', 'groupId': 'OG001'}, {'value': '339', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart (Meal)', 'description': 'Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG001', 'title': 'Faster Aspart (Post)', 'description': 'Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG002', 'title': 'NovoRapid (Meal)', 'description': 'After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.0', 'spread': '9.5', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '9.4', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '13.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for aspartate aminotransferase measurement.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Bilirubin 26 Weeks After Randomisation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '339', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart (Meal)', 'description': 'Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG001', 'title': 'Faster Aspart (Post)', 'description': 'Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG002', 'title': 'NovoRapid (Meal)', 'description': 'After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '3.9', 'groupId': 'OG001'}, {'value': '-0.2', 'spread': '3.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.', 'unitOfMeasure': 'umol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for total bilirubin measurement.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Potassium 26 Weeks After Randomisation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '339', 'groupId': 'OG001'}, {'value': '339', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart (Meal)', 'description': 'Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG001', 'title': 'Faster Aspart (Post)', 'description': 'Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG002', 'title': 'NovoRapid (Meal)', 'description': 'After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.01', 'spread': '0.43', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.42', 'groupId': 'OG001'}, {'value': '0.04', 'spread': '0.43', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for potassium measurement.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Creatinine 26 Weeks After Randomisation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '339', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart (Meal)', 'description': 'Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG001', 'title': 'Faster Aspart (Post)', 'description': 'Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG002', 'title': 'NovoRapid (Meal)', 'description': 'After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'spread': '8.8', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '7.5', 'groupId': 'OG001'}, {'value': '1.8', 'spread': '15.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.', 'unitOfMeasure': 'umol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for creatinine measurement.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Protein 26 Weeks After Randomisation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '339', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart (Meal)', 'description': 'Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG001', 'title': 'Faster Aspart (Post)', 'description': 'Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG002', 'title': 'NovoRapid (Meal)', 'description': 'After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.03', 'spread': '0.40', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.37', 'groupId': 'OG001'}, {'value': '-0.02', 'spread': '0.36', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for total protein measurement.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Urinary Albumin-to-creatinine Ratio 26 Weeks After Randomisation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '339', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart (Meal)', 'description': 'Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG001', 'title': 'Faster Aspart (Post)', 'description': 'Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG002', 'title': 'NovoRapid (Meal)', 'description': 'After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.636', 'spread': '7.361', 'groupId': 'OG000'}, {'value': '-0.379', 'spread': '11.095', 'groupId': 'OG001'}, {'value': '0.656', 'spread': '12.739', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.', 'unitOfMeasure': 'mg/mmol', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for urinary albumin and creatinine measurement.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Urinalysis (Ketones) 26 Weeks After Randomisation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart (Meal)', 'description': 'Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG001', 'title': 'Faster Aspart (Post)', 'description': 'Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG002', 'title': 'NovoRapid (Meal)', 'description': 'After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}], 'classes': [{'title': 'Week 0: Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '96.2', 'groupId': 'OG000'}, {'value': '97.1', 'groupId': 'OG001'}, {'value': '92.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 0: Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 0: Trace', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}, {'value': '5.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 0: 1+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '1.2', 'groupId': 'OG001'}, {'value': '1.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 0: 2+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 0: 3+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Last on-treatment value: Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '339', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '92.3', 'groupId': 'OG000'}, {'value': '89.7', 'groupId': 'OG001'}, {'value': '90.0', 'groupId': 'OG002'}]}]}, {'title': 'Last on-treatment value:Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '339', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Last on-treatment value: Trace', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '339', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000'}, {'value': '6.5', 'groupId': 'OG001'}, {'value': '6.5', 'groupId': 'OG002'}]}]}, {'title': 'Last on-treatment value:1+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '339', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000'}, {'value': '3.2', 'groupId': 'OG001'}, {'value': '2.9', 'groupId': 'OG002'}]}]}, {'title': 'Last on-treatment value: 2+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '339', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}, {'value': '0.6', 'groupId': 'OG001'}, {'value': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'Last on-treatment value: 3+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '339', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0, week 26', 'description': 'Presence of ketone in urine was assessed by urine dipstick and categorised as: Negative, Positive, Trace, 1+, 2+, 3+. Change from baseline is represented in terms of percentage of patients with ketone values at week 0 and week 26 (last on-treatment value). Last on-treatment value contains the last available measurement in the on-treatment period.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on SAS. Number analysed=number of subjects with available data for ketones values.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Urinalysis (Protein) 26 Weeks After Randomisation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart (Meal)', 'description': 'Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG001', 'title': 'Faster Aspart (Post)', 'description': 'Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG002', 'title': 'NovoRapid (Meal)', 'description': 'After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}], 'classes': [{'title': 'Week 0: Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '82.2', 'groupId': 'OG000'}, {'value': '79.5', 'groupId': 'OG001'}, {'value': '80.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 0: Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 0: Trace', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12.0', 'groupId': 'OG000'}, {'value': '14.4', 'groupId': 'OG001'}, {'value': '13.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 0: 1+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000'}, {'value': '4.1', 'groupId': 'OG001'}, {'value': '3.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 0: 2+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}, {'value': '1.2', 'groupId': 'OG001'}, {'value': '2.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 0: 3+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}, {'value': '0.9', 'groupId': 'OG001'}, {'value': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'Last on-treatment value: Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '339', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '83.5', 'groupId': 'OG000'}, {'value': '82.6', 'groupId': 'OG001'}, {'value': '78.8', 'groupId': 'OG002'}]}]}, {'title': 'Last on-treatment value:Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '339', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Last on-treatment value: Trace', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '339', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.6', 'groupId': 'OG000'}, {'value': '10.9', 'groupId': 'OG001'}, {'value': '12.4', 'groupId': 'OG002'}]}]}, {'title': 'Last on-treatment value:1+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '339', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000'}, {'value': '4.7', 'groupId': 'OG001'}, {'value': '6.5', 'groupId': 'OG002'}]}]}, {'title': 'Last on-treatment value: 2+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '339', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000'}, {'value': '1.2', 'groupId': 'OG001'}, {'value': '2.1', 'groupId': 'OG002'}]}]}, {'title': 'Last on-treatment value: 3+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '339', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}, {'value': '0.6', 'groupId': 'OG001'}, {'value': '0.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0, week 26', 'description': 'Presence of protein in urine was assessed by urine dipstick and categorised as: Negative, Positive, Trace, 1+, 2+, 3+. Change from baseline is represented in terms of percentage of patients with protein values at week 0 and week 26 (last on-treatment value). Last on-treatment value contains the last available measurement in the on-treatment period.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on SAS. Number analysed=number of subjects with available data for protein values.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Urinalysis (Erythrocytes) 26 Weeks After Randomisation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart (Meal)', 'description': 'Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG001', 'title': 'Faster Aspart (Post)', 'description': 'Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG002', 'title': 'NovoRapid (Meal)', 'description': 'After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}], 'classes': [{'title': 'Week 0: Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '95.3', 'groupId': 'OG000'}, {'value': '93.3', 'groupId': 'OG001'}, {'value': '93.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 0: Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 0: Trace', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '2.3', 'groupId': 'OG001'}, {'value': '3.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 0: 1+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '1.5', 'groupId': 'OG001'}, {'value': '2.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 0: 2+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}, {'value': '0.9', 'groupId': 'OG001'}, {'value': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'Week 0: 3+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '2.1', 'groupId': 'OG001'}, {'value': '0.9', 'groupId': 'OG002'}]}]}, {'title': 'Last on-treatment value: Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '339', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '93.5', 'groupId': 'OG000'}, {'value': '91.7', 'groupId': 'OG001'}, {'value': '91.8', 'groupId': 'OG002'}]}]}, {'title': 'Last on-treatment value:Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '339', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Last on-treatment value: Trace', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '339', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}, {'value': '3.8', 'groupId': 'OG001'}, {'value': '2.6', 'groupId': 'OG002'}]}]}, {'title': 'Last on-treatment value:1+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '339', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000'}, {'value': '0.9', 'groupId': 'OG001'}, {'value': '2.1', 'groupId': 'OG002'}]}]}, {'title': 'Last on-treatment value: 2+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '339', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}, {'value': '2.1', 'groupId': 'OG001'}, {'value': '1.8', 'groupId': 'OG002'}]}]}, {'title': 'Last on-treatment value: 3+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '339', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '1.5', 'groupId': 'OG001'}, {'value': '1.8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0, week 26', 'description': 'Presence of erythrocytes in urine was assessed by urine dipstick and categorised as: Negative, Positive, Trace, 1+, 2+, 3+. Change from baseline is represented in terms of percentage of patients with erythrocytes values at week 0 and week 26 (last on-treatment value). Last on-treatment value contains the last available measurement in the on-treatment period.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on SAS. Number analysed=number of subjects with available data for erythrocytes values.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Anti-insulin Aspart (Specific and Cross-reacting With Human Insulin) Antibody Development 26 Weeks After Randomisation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart (Meal)', 'description': 'Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG001', 'title': 'Faster Aspart (Post)', 'description': 'Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG002', 'title': 'NovoRapid (Meal)', 'description': 'After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}], 'classes': [{'title': 'Anti-insulin aspart specific antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '337', 'groupId': 'OG000'}, {'value': '333', 'groupId': 'OG001'}, {'value': '333', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.033', 'spread': '0.777', 'groupId': 'OG000'}, {'value': '-0.027', 'spread': '1.077', 'groupId': 'OG001'}, {'value': '-0.013', 'spread': '1.568', 'groupId': 'OG002'}]}]}, {'title': 'Cross-reacting to human insulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '337', 'groupId': 'OG000'}, {'value': '334', 'groupId': 'OG001'}, {'value': '332', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.972', 'spread': '6.028', 'groupId': 'OG000'}, {'value': '-1.799', 'spread': '6.812', 'groupId': 'OG001'}, {'value': '-1.427', 'spread': '5.527', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'Insulin aspart antibody titres (antibodies specific for insulin aspart and those cross-reacting with human insulin) measured at baseline and at 26 weeks. Week 26 data are based on the last on-treatment value which contains the last available measurement in the on-treatment period. Anti-insulin aspart antibody was measured as % bound radioactivity-labelled insulin aspart/Total added radioactivity-labelled insulin aspart (%B/T).', 'unitOfMeasure': '% B/T', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on the SAS. Number analysed=number of subjects with available data for anti-insulin aspart antibody.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Weight 26 Weeks After Randomisation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart (Meal)', 'description': 'Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG001', 'title': 'Faster Aspart (Post)', 'description': 'Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG002', 'title': 'NovoRapid (Meal)', 'description': 'After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.43', 'spread': '2.66', 'groupId': 'OG000'}, {'value': '1.14', 'spread': '2.95', 'groupId': 'OG001'}, {'value': '1.24', 'spread': '2.60', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on SAS. Number of subjects analysed=subject with data available for body weight.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Mass Index 26 Weeks After Randomisation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}, {'value': '340', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Faster Aspart (Meal)', 'description': 'Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG001', 'title': 'Faster Aspart (Post)', 'description': 'Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'OG002', 'title': 'NovoRapid (Meal)', 'description': 'After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.49', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '0.39', 'spread': '1.02', 'groupId': 'OG001'}, {'value': '0.43', 'spread': '0.89', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on SAS. Number of subjects analysed=subject with data available for body mass index.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Faster Aspart (Meal)', 'description': 'Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'FG001', 'title': 'Faster Aspart (Post)', 'description': 'Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'FG002', 'title': 'NovoRapid (Meal)', 'description': 'After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '342'}, {'groupId': 'FG001', 'numSubjects': '341'}, {'groupId': 'FG002', 'numSubjects': '342'}]}, {'type': 'Exposed', 'achievements': [{'groupId': 'FG000', 'numSubjects': '342'}, {'groupId': 'FG001', 'numSubjects': '341'}, {'groupId': 'FG002', 'numSubjects': '342'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '338'}, {'groupId': 'FG001', 'numSubjects': '334'}, {'groupId': 'FG002', 'numSubjects': '335'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Unclassified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The trial was conducted at 146 sites in 12 countries(number of sites indicates those that both screened and randomised subjects, unless otherwise noted)-Austria(4);Bulgaria(8); Canada(6); Germany(7); India(16); Israel(6); Italy(4); Japan(24); Russian Federation(10); Serbia(3); Taiwan(3); United States(55 sites screened/52 sites randomised subjects)', 'preAssignmentDetails': 'Eligible subjects were enrolled in a 8-week run-in period (1108 subjects) where subjects were switched from previous insulin treatment to insulin degludec once daily,and NovoRapid®/NovoLog® as mealtime bolus insulin. The basal insulin treatment was optimised using treat-to-target approach. 83 subjects were run-in failures and 1025 were randomised.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'BG000'}, {'value': '341', 'groupId': 'BG001'}, {'value': '342', 'groupId': 'BG002'}, {'value': '1025', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Faster Aspart (Meal)', 'description': 'Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'BG001', 'title': 'Faster Aspart (Post)', 'description': 'Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'BG002', 'title': 'NovoRapid (Meal)', 'description': 'After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.\n\nBasal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.48', 'spread': '14.42', 'groupId': 'BG000'}, {'value': '41.02', 'spread': '14.59', 'groupId': 'BG001'}, {'value': '40.77', 'spread': '14.22', 'groupId': 'BG002'}, {'value': '41.09', 'spread': '14.40', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '158', 'groupId': 'BG000'}, {'value': '155', 'groupId': 'BG001'}, {'value': '163', 'groupId': 'BG002'}, {'value': '476', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '184', 'groupId': 'BG000'}, {'value': '186', 'groupId': 'BG001'}, {'value': '179', 'groupId': 'BG002'}, {'value': '549', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '329', 'groupId': 'BG000'}, {'value': '333', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}, {'value': '992', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '116', 'groupId': 'BG000'}, {'value': '131', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}, {'value': '384', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '219', 'groupId': 'BG000'}, {'value': '206', 'groupId': 'BG001'}, {'value': '198', 'groupId': 'BG002'}, {'value': '623', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Glycosylated hemoglobin (HbA1c)', 'classes': [{'categories': [{'measurements': [{'value': '7.46', 'spread': '0.68', 'groupId': 'BG000'}, {'value': '7.40', 'spread': '0.60', 'groupId': 'BG001'}, {'value': '7.41', 'spread': '0.79', 'groupId': 'BG002'}, {'value': '7.42', 'spread': '0.70', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage of HbA1c', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Full analysis set (FAS) included all randomised subjects.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-13', 'size': 739720, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-07-16T02:13', 'hasProtocol': True}, {'date': '2018-03-13', 'size': 8918850, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-07-16T02:13', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2017-08-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-28', 'studyFirstSubmitDate': '2015-07-15', 'resultsFirstSubmitDate': '2018-07-16', 'studyFirstSubmitQcDate': '2015-07-15', 'lastUpdatePostDateStruct': {'date': '2019-06-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-07-16', 'studyFirstPostDateStruct': {'date': '2015-07-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in HbA1c 26 Weeks After Randomisation', 'timeFrame': 'Week 0, week 26', 'description': 'Change from baseline (week 0) in HbA1c was evaluated after 26 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In-trial period: the observation period from date of randomisation until last trial-related subject-site contact.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in 1-hour Post Prandial Glucose (PPG) Increment 26 Weeks After Randomisation (Meal Test)', 'timeFrame': 'Week 0, week 26', 'description': 'The 1-hour PPG increment was analysed based on the laboratory-measured values in the meal test, and was derived using the 1-hour PPG measurement minus the pre-prandial plasma glucose (PG). The results are based on the last in-trial value, which included the last available measurement in the in-trial period.'}, {'measure': 'Change From Baseline in 1,5-anhydroglucitol 26 Weeks After Randomisation', 'timeFrame': 'Week 0, week 26', 'description': 'The results are based on the last in-trial value, which included the last available measurement in the in-trial period.'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose (FPG) 26 Weeks After Randomisation', 'timeFrame': 'Week 0, week 26', 'description': 'The results are based on the last in-trial value, which included the last available measurement in the in-trial period.'}, {'measure': 'Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0%) 26 Weeks After Randomisation', 'timeFrame': '26 weeks after randomisation', 'description': 'The percentage of subjects who achieved the HbA1c target of \\<7.0% 26 weeks after randomisation. Subjects without an HbA1c measurement at week 26 were treated as non-responders.'}, {'measure': 'Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia) 26 Weeks After Randomisation', 'timeFrame': '26 weeks after randomisation', 'description': 'The percentage of subjects who achieved the HbA1c target of \\<7.0% without severe hypoglycaemia 26 weeks after randomisation. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Subjects without an HbA1c measurement at week 26 were treated as non-responders.'}, {'measure': 'Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia and Minimal Weight Gain [<3.0%]) 26 Weeks After Randomisation', 'timeFrame': '26 weeks after randomisation', 'description': 'The percentage of subjects who achieved the HbA1c target of \\<7.0% without severe hypoglycaemia and with minimal weight gain (defined as less than a 3% increase) 26 weeks after randomisation. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Subjects without an HbA1c measurement at week 26 or without body weight measurement at week 26 were treated as non-responders.'}, {'measure': 'Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG 26 Weeks After Randomisation', 'timeFrame': 'Week 0, week 26', 'description': 'Laboratory measured PG from the meal test was analysed for 30, 60, 120, 180, and 240 minutes PPG separately. 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 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG Increment 26 Weeks After Randomisation', 'timeFrame': 'Week 0, week 26', 'description': 'Laboratory measured PG from the meal test was analysed for 30, 60, 120, 180, and 240 minutes PPG separately. The corresponding PPG increments were derived separately using each PPG measurement minus the pre-prandial PG. 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) 26 Weeks After Randomisation: Mean of the 7-9-7-point Profile', 'timeFrame': 'Week 0, week 26', 'description': 'The subject was instructed to perform a 7-9-7 SMPG point profile 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 26 Weeks After Randomisation: PPG (Mean, Breakfast, Lunch, Main Evening Meal)', 'timeFrame': 'Week 0, week 26', 'description': 'The subject was instructed to perform a 7-9-7 SMPG point profile 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 26 Weeks After Randomisation: PPG Increment (Mean, Breakfast, Lunch, Main Evening Meal)', 'timeFrame': 'Week 0, week 26', 'description': 'The subject was instructed to perform a 7-9-7 SMPG point profile 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 (breakfast, lunch, main evening 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 26 Weeks After Randomisation: Fluctuation in 7-9-7-point Profile', 'timeFrame': 'Week 0, week 26', 'description': 'The subject was instructed to perform a 7-9-7 SMPG point profile 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. 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. 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 26 Weeks After Randomisation: Change in the Nocturnal Self-measured Plasma Glucose Measurements', 'timeFrame': 'Week 0, week 26', 'description': 'The subject was instructed to perform 7-9-7 SMPG point profile on 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 following day. Change from baseline in nocturnal PG values (nocturnal increments) was assessed by considering differences between PG values available at bedtime, at 4 a.m and the before breakfast value the following day: (04:00 PG value minus at bedtime PG value), (before breakfast PG value minus at bedtime PG value) and (before breakfast PG value minus 04:00 PG value). Results are based on the last in-trial value (the last available measurement in the in-trial period).'}, {'measure': 'Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L', 'timeFrame': '26 weeks after randomisation', 'description': 'Percentage of subjects achieving an overall mean 1-hour PPG ≤7.8 mmol/L \\[140 mg/dL\\] 26 weeks after randomisation. Subjects without an overall mean 1-hour PPG at week 26 were treated as non-responders.'}, {'measure': 'Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L Without Severe Hypoglycaemia', 'timeFrame': '26 weeks after randomisation', 'description': 'Percentage of subjects achieving an overall mean 1-hour PPG ≤7.8 mmol/L \\[140 mg/dL\\] 26 weeks after randomisation without severe hypoglycaemia. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Subjects without an overall mean 1-hour PPG at week 26 were treated as non-responders.'}, {'measure': 'Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L and HbA1c <7.0% and Minimal Weight Gain (<3.0%) Without Severe Hypoglycaemia', 'timeFrame': '26 weeks after randomisation', 'description': 'The percentage of subjects who achieved overall mean 1 hour PPG ≤7.8 mmol/L \\[140 mg/dL\\], had HbA1c \\< 7.0% and had minimal weight gain (increase in body weight from baseline \\<3.0%) 26 weeks after randomisation, and without severe hypoglycaemic episodes. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Subjects without an overall mean 1-hour PPG or an HbA1c value or a body weight at week 26 were treated as non-responders.'}, {'measure': 'Change From Baseline in Lipids-lipoproteins Profile 26 Weeks After Randomisation (Total Cholesterol, High Density Lipoproteins [HDL] Cholesterol, Low Density Lipoproteins [LDL] Cholesterol)', 'timeFrame': 'Week 0, week 26', 'description': 'Change from baseline in HDL cholesterol, LDL cholesterol and total cholesterol 26 weeks after randomization are represented as ratio to baseline values. The results are based on the last in-trial value (the last available measurement in the in-trial period).'}, {'measure': 'Insulin Dose (Basal Insulin Dose, Total and Individual Meal Insulin Dose)', 'timeFrame': 'Week 0, week 26', 'description': 'The insulin doses were summarised descriptively at week 0 and week 26 both by meal type and as total daily dose (total daily and separately for each mealtime dose). Week 26 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 During 26 Weeks After Randomisation', 'timeFrame': 'Week 0 to week 26 (+7 days)', 'description': 'A treatment emergent adverse event (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 randomised treatment.'}, {'measure': 'Number of Treatment-emergent Injection Site Reactions During the 26 Weeks After Randomisation', 'timeFrame': 'Week 0 to week 26 (+7 days)', 'description': 'A treatment emergent event 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 randomised treatment.'}, {'measure': 'Number of Hypoglycaemic Episodes Classified Both According to the American Diabetes Association (ADA) Definition and Novo Nordisk (NN) Definition During 26 Weeks After Randomisation: Overall', 'timeFrame': 'Week 0 to week 26 (+1 day)', 'description': 'ADA classification includes following criteria: Severe,Documented symptomatic,Asymptomatic,Probable symptomatic,Pseudo-hypoglycaemia.\n\nNN Classification:\n\n* Severe:same as per ADA classification\n* Symptomatic blood glucose (BG) confirmed: PG\\<3.1 mmol/L with symptoms consistent with hypoglycaemia\n* Asymptomatic BG confirmed:PG\\<3.1 mmol/L without symptoms consistent with hypoglycaemia\n* Severe or BG confirmed symptomatic:severe according to ADA classification or BG confirmed by PG\\<3.1 mmol/L with symptoms consistent with hypoglycaemia\n* BG confirmed:PG\\<3.1 mmol/L with or without symptoms consistent with hypoglycaemia\n* Severe or BG confirmed:severe according to ADA classification or BG confirmed by PG\\<3.1 mmol/L with or without symptoms consistent with hypoglycaemia\n* Unclassifiable Results represent total number of hypoglycaemic episodes. Treatment emergent episode: an event that has onset up to 1 day after last day of randomised treatment and excluding events occurring in run-in period.'}, {'measure': 'Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: Daytime and Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive)', 'timeFrame': 'Week 0 to week 26 (+1 day)', 'description': 'ADA classification includes following criteria: Severe, Documented symptomatic, Asymptomatic, Probable symptomatic, Pseudo-hypoglycaemia.\n\nNN Classification:\n\n* Severe: same as per ADA classification\n* Symptomatic BG confirmed: PG\\<3.1 mmol/L with symptoms consistent with hypoglycaemia\n* Asymptomatic BG confirmed: PG\\<3.1 mmol/L without symptoms consistent with hypoglycaemia\n* Severe or BG confirmed symptomatic: severe according to the ADA classification or BG confirmed by PG\\<3.1 mmol/Lwith symptoms consistent with hypoglycaemia\n* BG confirmed: PG\\<3.1 mmol/L with or without symptoms consistent with hypoglycaemia\n* Severe or BG confirmed: severe according to the ADA classification or BG confirmed by PG\\<3.1 mmol/L with or without symptoms consistent with hypoglycaemia\n* Unclassifiable Results represent total number of hypoglycaemic episodes. Nocturnal hypoglycaemic episodes were episodes occurring between 00:01 and 05:59 both inclusive.'}, {'measure': 'Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: From Start of Meal Until 1,2, 4 Hours and From 2 Hours (Exclusive) to 4 Hours (Inclusive) After Start of Meal', 'timeFrame': 'Week 0 to week 26 (+1 day)', 'description': 'ADA classification includes following criteria: Severe, Documented symptomatic, Asymptomatic, Probable symptomatic, Pseudo-hypoglycaemia.\n\nNN Classification:\n\n* Severe: same as per ADA classification\n* Symptomatic BG confirmed: PG\\<3.1 mmol/L with symptoms consistent with hypoglycaemia\n* Asymptomatic BG confirmed: PG\\<3.1 mmol/L without symptoms consistent with hypoglycaemia\n* Severe or BG confirmed symptomatic: severe according to the ADA classification or BG confirmed by PG\\<3.1 mmol/Lwith symptoms consistent with hypoglycaemia\n* BG confirmed: PG\\<3.1 mmol/L with or without symptoms consistent with hypoglycaemia\n* Severe or BG confirmed: severe according to the ADA classification or BG confirmed by PG\\<3.1 mmol/L with or without symptoms consistent with hypoglycaemia\n* Unclassifiable Results represent total number of hypoglycaemic episodes related to meals.'}, {'measure': 'Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination)', 'timeFrame': 'Week 0, week 26', 'description': "The physical examination parameters included head, ears, eyes, nose, throat, neck; respiratory system; cardiovascular system; gastrointestinal system including mouth; musculoskeletal system; central and peripheral nervous system; and skin. The examinations were measured as 'normal', 'abnormal, not clinically significant' (Abn, NCS) or 'abnormal, clinically significant' (Abn, CS). Reported results are percentage of subjects with 'normal', 'Abn, NCS' and 'Abn, CS' physical examinations at week 0 and week 26. Week 26 results are based on the last on-treatment value (last value), which included the last available measurement in the on-treatment period."}, {'measure': 'Change From Baseline in Blood Pressure 26 Weeks After Randomisation', 'timeFrame': 'Week 0, week 26', 'description': 'Change from baseline in systolic blood pressure and diastolic blood pressure 26 weeks after randomisation. Results are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.'}, {'measure': 'Change From Baseline in Pulse 26 Weeks After Randomisation', 'timeFrame': 'Week 0, week 26', 'description': 'Results are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.'}, {'measure': 'Change From Baseline in Clinical Evaluation (Electrocardiogram) 26 Weeks After Randomisation', 'timeFrame': 'Week 0, week 26', 'description': "The electrocardiogram was interpreted by the investigator into following categories: Normal; Abn, NCS; Abnormal, CS. Reported results are percentage of subjects with 'normal', 'Abn, NCS' and 'Abn, CS' physical examinations at week 0 and week 26. Week 26 data are based on the last on-treatment value which contains the last available measurement in the on-treatment period."}, {'measure': 'Change From Baseline in Clinical Evaluation (Fundoscopy/Fundus Photography) 26 Weeks After Randomisation', 'timeFrame': 'Week 0, week 26', 'description': "The result of the fundus photography/dilated fundoscopy was interpreted by the investigator into following categories: Normal; Abn, NCS; Abnormal, CS. Reported results are percentage of subjects with 'normal', 'Abn, NCS' and 'Abn, CS' fundoscopy/fundus photography results at week 0 and week 26. Week 26 data are based on the last on-treatment value which contains the last available measurement in the on-treatment period."}, {'measure': 'Change From Baseline in Erythrocytes 26 Weeks After Randomisation', 'timeFrame': 'Week 0, week 26', 'description': 'Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.'}, {'measure': 'Change From Baseline in Haematocrit 26 Weeks After Randomisation', 'timeFrame': 'Week 0, week 26', 'description': 'Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.'}, {'measure': 'Change From Baseline in Haemoglobin 26 Weeks After Randomisation', 'timeFrame': 'Week 0, week 26', 'description': 'Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.'}, {'measure': 'Change From Baseline in Leukocytes 26 Weeks After Randomisation', 'timeFrame': 'Week 0, week 26', 'description': 'Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.'}, {'measure': 'Change From Baseline in Thrombocytes 26 Weeks After Randomisation', 'timeFrame': 'Week 0, week 26', 'description': 'Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.'}, {'measure': 'Change From Baseline in Alanine Aminotransferase 26 Weeks After Randomisation', 'timeFrame': 'Week 0, week 26', 'description': 'Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.'}, {'measure': 'Change From Baseline in Albumin 26 Weeks After Randomisation', 'timeFrame': 'Week 0, week 26', 'description': 'Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.'}, {'measure': 'Change From Baseline in Alkaline Phosphatase 26 Weeks After Randomisation', 'timeFrame': 'Week 0, week 26', 'description': 'Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.'}, {'measure': 'Change From Baseline in Aspartate Aminotransferase 26 Weeks After Randomisation', 'timeFrame': 'Week 0, week 26', 'description': 'Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.'}, {'measure': 'Change From Baseline in Total Bilirubin 26 Weeks After Randomisation', 'timeFrame': 'Week 0, week 26', 'description': 'Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.'}, {'measure': 'Change From Baseline in Potassium 26 Weeks After Randomisation', 'timeFrame': 'Week 0, week 26', 'description': 'Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.'}, {'measure': 'Change From Baseline in Creatinine 26 Weeks After Randomisation', 'timeFrame': 'Week 0, week 26', 'description': 'Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.'}, {'measure': 'Change From Baseline in Total Protein 26 Weeks After Randomisation', 'timeFrame': 'Week 0, week 26', 'description': 'Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.'}, {'measure': 'Change From Baseline in Urinary Albumin-to-creatinine Ratio 26 Weeks After Randomisation', 'timeFrame': 'Week 0, week 26', 'description': 'Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.'}, {'measure': 'Change From Baseline in Urinalysis (Ketones) 26 Weeks After Randomisation', 'timeFrame': 'Week 0, week 26', 'description': 'Presence of ketone in urine was assessed by urine dipstick and categorised as: Negative, Positive, Trace, 1+, 2+, 3+. Change from baseline is represented in terms of percentage of patients with ketone values at week 0 and week 26 (last on-treatment value). Last on-treatment value contains the last available measurement in the on-treatment period.'}, {'measure': 'Change From Baseline in Urinalysis (Protein) 26 Weeks After Randomisation', 'timeFrame': 'Week 0, week 26', 'description': 'Presence of protein in urine was assessed by urine dipstick and categorised as: Negative, Positive, Trace, 1+, 2+, 3+. Change from baseline is represented in terms of percentage of patients with protein values at week 0 and week 26 (last on-treatment value). Last on-treatment value contains the last available measurement in the on-treatment period.'}, {'measure': 'Change From Baseline in Urinalysis (Erythrocytes) 26 Weeks After Randomisation', 'timeFrame': 'Week 0, week 26', 'description': 'Presence of erythrocytes in urine was assessed by urine dipstick and categorised as: Negative, Positive, Trace, 1+, 2+, 3+. Change from baseline is represented in terms of percentage of patients with erythrocytes values at week 0 and week 26 (last on-treatment value). Last on-treatment value contains the last available measurement in the on-treatment period.'}, {'measure': 'Change From Baseline in Anti-insulin Aspart (Specific and Cross-reacting With Human Insulin) Antibody Development 26 Weeks After Randomisation', 'timeFrame': 'Week 0, week 26', 'description': 'Insulin aspart antibody titres (antibodies specific for insulin aspart and those cross-reacting with human insulin) measured at baseline and at 26 weeks. Week 26 data are based on the last on-treatment value which contains the last available measurement in the on-treatment period. Anti-insulin aspart antibody was measured as % bound radioactivity-labelled insulin aspart/Total added radioactivity-labelled insulin aspart (%B/T).'}, {'measure': 'Change From Baseline in Body Weight 26 Weeks After Randomisation', 'timeFrame': 'Week 0, week 26', 'description': 'The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.'}, {'measure': 'Change From Baseline in Body Mass Index 26 Weeks After Randomisation', 'timeFrame': 'Week 0, week 26', 'description': 'The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 1']}, 'referencesModule': {'references': [{'pmid': '30949906', 'type': 'BACKGROUND', 'citation': 'Rose L, Kadowaki T, Pieber TR, Buchholtz K, Ekelund M, Gorst-Rasmussen A, Philis-Tsimikas A. Efficacy and Safety of Fast-Acting Insulin Aspart in People with Type 1 Diabetes Using Carbohydrate Counting: A Post Hoc Analysis of Two Randomised Controlled Trials. Diabetes Ther. 2019 Jun;10(3):1029-1041. doi: 10.1007/s13300-019-0608-4. Epub 2019 Apr 4.'}, {'pmid': '30259644', 'type': 'RESULT', 'citation': 'Buse JB, Carlson AL, Komatsu M, Mosenzon O, Rose L, Liang B, Buchholtz K, Horio H, Kadowaki T. Fast-acting insulin aspart versus insulin aspart in the setting of insulin degludec-treated type 1 diabetes: Efficacy and safety from a randomized double-blind trial. Diabetes Obes Metab. 2018 Dec;20(12):2885-2893. doi: 10.1111/dom.13545. Epub 2018 Oct 10.'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Asia, Europe and North America. The purpose is to confirm efficacy in terms of glycaemic control of treatment with mealtime faster-acting insulin aspart in combination with insulin degludec in adults with Type 1 Diabetes Mellitus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: - Male or female, age greater than or equal to 18 years ( for Japan and Taiwan: age greater than or equal to 20 years) at the time of signing informed consent - Type 1 Diabetes Mellitus (based on clinical judgement and/or supported by laboratory analysis as per local guidelines) 12 months or more prior to screening - Currently treated with a basal-bolus insulin regimen for at least 12 months prior to screening (Visit 1) - Currently treated with a basal insulin analogue for at least 4 months prior to screening (Visit 1) - HbA1c 7.0-9.5% (53-80 mmol/mol) (both inclusive) as assessed by central laboratory - Body Mass Index less than or equal to 35.0 kg/m\\^2 Exclusion Criteria: - Within the past 180 days any of the following: myocardial infarction, stroke or hospitalization for unstable angina and/or transient ischemic attack - Subjects presently classified as being in New York Heart Association (NYHA) Class IV Currently planned coronary, carotid or peripheral artery revascularisation - Diabetic ketoacidosis requiring hospitalisation within the last 180 days prior to screening (Visit 1) - Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of three months before screening (Visit 1)'}, 'identificationModule': {'nctId': 'NCT02500706', 'acronym': 'onset®8', 'briefTitle': 'Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec in Adults With Type 1 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec in Adults With Type 1 Diabetes', 'orgStudyIdInfo': {'id': 'NN1218-4131'}, 'secondaryIdInfos': [{'id': '2015-001047-36', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1167-9495', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mealtime faster-acting insulin aspart and insulin degludec', 'interventionNames': ['Drug: Faster-acting insulin aspart', 'Drug: insulin degludec']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mealtime NovoRapid® and insulin degludec', 'interventionNames': ['Drug: insulin aspart', 'Drug: insulin degludec']}, {'type': 'EXPERIMENTAL', 'label': 'Postmeal faster-acting insulin aspart and insulin degludec', 'interventionNames': ['Drug: Faster-acting insulin aspart', 'Drug: insulin degludec']}], 'interventions': [{'name': 'Faster-acting insulin aspart', 'type': 'DRUG', 'description': 'Injected subcutaneously (under the skin) three times daily for 26 weeks. Dose individually adjusted. Mealtime dosing is defined as injecting 0-2 minutes before the meal. Postmeal dosing is defined as injecting 20 minutes after the start of the meal.', 'armGroupLabels': ['Mealtime faster-acting insulin aspart and insulin degludec', 'Postmeal faster-acting insulin aspart and insulin degludec']}, {'name': 'insulin aspart', 'type': 'DRUG', 'description': 'Injected subcutaneously (under the skin) three times daily for 26 weeks. Dose individually adjusted. Mealtime dosing is defined as injecting 0-2 minutes before the meal.', 'armGroupLabels': ['Mealtime NovoRapid® and insulin degludec']}, {'name': 'insulin degludec', 'type': 'DRUG', 'description': 'Injected subcutaneously (under the skin) once daily for 26 weeks. Dose individually adjusted', 'armGroupLabels': ['Mealtime NovoRapid® and insulin degludec', 'Mealtime faster-acting insulin aspart and insulin degludec', 'Postmeal faster-acting insulin aspart and insulin degludec']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85714', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '94520', 'city': 'Concord', 'state': 'California', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 37.97798, 'lon': -122.03107}}, {'zip': '91436', 'city': 'Encino', 'state': 'California', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 34.15917, 'lon': -118.50119}}, {'zip': '92025', 'city': 'Escondido', 'state': 'California', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 33.11921, 'lon': 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