Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-01-29 @ 3:04 PM
Study NCT ID:
NCT03175120
Status:
COMPLETED
Last Update Posted:
2020-03-19
First Post:
2017-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Trial Comparing Insulin Degludec/Liraglutide and Insulin Degludec in Combination With Metformin in Chinese Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin Therapy and Metformin With or Without One Other Oral Antidiabetic Drug (OAD)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-03-12', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000613158', 'term': 'IDegLira'}, {'id': 'C571886', 'term': 'insulin degludec'}]}}, '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': 'Weeks 0-30', 'description': 'All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants who received at least one dose of IDegLira or IDeg.', 'eventGroups': [{'id': 'EG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.', 'otherNumAtRisk': 301, 'deathsNumAtRisk': 301, 'otherNumAffected': 113, 'seriousNumAtRisk': 301, 'deathsNumAffected': 0, 'seriousNumAffected': 13}, {'id': 'EG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.', 'otherNumAtRisk': 151, 'deathsNumAtRisk': 151, 'otherNumAffected': 43, 'seriousNumAtRisk': 151, 'deathsNumAffected': 0, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 23, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Diabetic retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 35, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 30, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 38, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 45, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 32, 'numAffected': 27}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}], 'seriousEvents': [{'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Epiglottitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Fibroadenoma of breast', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Osteoporotic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Thyroglossal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in HbA1c', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.93', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '-1.06', 'spread': '1.19', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment contrast', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.92', 'ciLowerLimit': '-1.09', 'ciUpperLimit': '-0.75', 'groupDescription': 'The response and change from baseline in response after 26 weeks are analysed using an analysis of covariance (ANCOVA) model with treatment and previous anti-diabetic treatment as fixed factors and corresponding baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'Change in glycosylated haemoglobin (HbA1c) from baseline (week 0) to week 26 is presented.', 'unitOfMeasure': 'Percentage point of HbA1c', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants. Overall number of participants analysed = participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.7', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '2.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'Change in body weight from baseline (week 0) to week 26 is presented.', 'unitOfMeasure': 'Kilogram (kg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants. Overall number of participants analysed = participants with available data.'}, {'type': 'SECONDARY', 'title': 'Number of Treatment-emergent Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 26 weeks', 'description': 'Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification (requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value \\< 3.1 millimoles per liter (mmol/L) with or without symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Number of treatment-emergent severe or BG confirmed hypoglycaemic episodes during 26 weeks of treatment is presented.', 'unitOfMeasure': 'Episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set (SAS) included all participants who received at least one dose of IDegLira or IDeg.'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Plasma Glucose (FPG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.57', 'spread': '3.00', 'groupId': 'OG000'}, {'value': '-2.82', 'spread': '3.15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'Change in FPG from baseline (week 0) to week 26 is presented.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants. Overall number of participants analysed = participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Waist Circumference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.4', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '3.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'Change in waist circumference from baseline (week 0) to week 26 is presented.', 'unitOfMeasure': 'Centimeter (cm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants. Overall number of participants analysed = participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Mean of the 9-point Self-measured Plasma Glucose (SMPG) Profile', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.35', 'spread': '2.63', 'groupId': 'OG000'}, {'value': '-2.31', 'spread': '2.61', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'Participants measured plasma glucose values using the blood glucose meter at 9 time points: before breakfast, 90 min after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 min after start of dinner, bedtime, at 4:00 am and before breakfast the following day. The mean of profile is defined as the area under the profile divided by measurement time and is calculated using the trapezoidal method. Change in mean of the 9-point SMPG profile from baseline (week 0) to week 26 is presented.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants. Overall number of participants analysed = participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in SMPG-mean Post Prandial Increments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.08', 'spread': '2.19', 'groupId': 'OG000'}, {'value': '0.28', 'spread': '2.71', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'Participants measured plasma glucose values using the blood glucose meter at 9 time points: before breakfast, 90 min after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 min after start of dinner, bedtime, at 4:00 am and before breakfast the following day. Change in SMPG-mean postprandial increment over all meals from baseline (week 0) to week 26 is presented.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants. Overall number of participants analysed = participants with available data.'}, {'type': 'SECONDARY', 'title': 'Insulin Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.6', 'spread': '11.1', 'groupId': 'OG000'}, {'value': '37.9', 'spread': '10.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 26', 'description': 'The mean of actual daily total insulin dose after 26 weeks of treatment is presented.', 'unitOfMeasure': 'Units of insulin (U)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants who received at least one dose of IDegLira or IDeg. Overall number of participants analysed = participants with available data.'}, {'type': 'SECONDARY', 'title': 'SMPG-9-point Profile (Individual Points in the Profile)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'title': 'Before breakfast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.48', 'spread': '1.06', 'groupId': 'OG000'}, {'value': '5.88', 'spread': '1.30', 'groupId': 'OG001'}]}]}, {'title': '90 minutes after start of breakfast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '279', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.51', 'spread': '2.66', 'groupId': 'OG000'}, {'value': '10.50', 'spread': '2.45', 'groupId': 'OG001'}]}]}, {'title': 'Before lunch', 'denoms': [{'units': 'Participants', 'counts': [{'value': '279', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.93', 'spread': '2.10', 'groupId': 'OG000'}, {'value': '8.17', 'spread': '3.19', 'groupId': 'OG001'}]}]}, {'title': '90 minutes after start of lunch', 'denoms': [{'units': 'Participants', 'counts': [{'value': '279', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.68', 'spread': '2.52', 'groupId': 'OG000'}, {'value': '11.21', 'spread': '2.93', 'groupId': 'OG001'}]}]}, {'title': 'Before main evening meal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '279', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.24', 'spread': '2.16', 'groupId': 'OG000'}, {'value': '7.87', 'spread': '2.65', 'groupId': 'OG001'}]}]}, {'title': '90 minutes after main evening meal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '278', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.87', 'spread': '2.53', 'groupId': 'OG000'}, {'value': '10.86', 'spread': '2.46', 'groupId': 'OG001'}]}]}, {'title': 'At bedtime', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.57', 'spread': '2.52', 'groupId': 'OG000'}, {'value': '9.52', 'spread': '2.61', 'groupId': 'OG001'}]}]}, {'title': 'At 4:00 a.m.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.97', 'spread': '1.49', 'groupId': 'OG000'}, {'value': '6.61', 'spread': '1.99', 'groupId': 'OG001'}]}]}, {'title': 'Before breakfast the following day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.48', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '5.83', 'spread': '1.52', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 26', 'description': 'Participants measured plasma glucose values using the blood glucose meter at 9 time points: before breakfast, 90 min after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 min after start of dinner, bedtime, at 4:00 am and before breakfast the following day. SMPG-9-point profile (individual points in the profile) at week 26 is presented.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants. Number analysed = participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Fasting High-density Lipoprotein (HDL) Cholesterol- Ratio to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.00', 'spread': '17.5', 'groupId': 'OG000'}, {'value': '1.03', 'spread': '15.9', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'Change in fasting HDL cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline.', 'unitOfMeasure': 'Ratio of HDL cholesterol', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants. Overall number of participants analysed = participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Low-density Lipoprotein (LDL) Cholesterol- Ratio to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.89', 'spread': '32.5', 'groupId': 'OG000'}, {'value': '0.95', 'spread': '37.7', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'Change in fasting LDL cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline.', 'unitOfMeasure': 'Ratio of LDL cholesterol', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants. Overall number of participants analysed = participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Very Low-density Lipoprotein (VLDL) Cholesterol- Ratio to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.92', 'spread': '55.2', 'groupId': 'OG000'}, {'value': '0.93', 'spread': '49.1', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'Change in fasting VLDL cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline.', 'unitOfMeasure': 'Ratio of VLDL cholesterol', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants. Overall number of participants analysed = participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Total Cholesterol- Ratio to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.92', 'spread': '19.1', 'groupId': 'OG000'}, {'value': '0.97', 'spread': '20.0', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'Change in fasting total cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline.', 'unitOfMeasure': 'Ratio of total cholesterol', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants. Overall number of participants analysed = participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Triglycerides- Ratio to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.91', 'spread': '63.7', 'groupId': 'OG000'}, {'value': '0.92', 'spread': '55.8', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'Change in fasting triglycerides (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline.', 'unitOfMeasure': 'Ratio of triglycerides', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants. Overall number of participants analysed = participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Free Fatty Acids- Ratio to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.65', 'spread': '76.4', 'groupId': 'OG000'}, {'value': '0.64', 'spread': '61.9', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'Change in fasting free fatty acids (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline.', 'unitOfMeasure': 'Ratio of free fatty acids', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants. Overall number of participants analysed = participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Fasting C-peptide- Ratio to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.64', 'spread': '71.2', 'groupId': 'OG000'}, {'value': '0.52', 'spread': '71.8', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'Change in fasting C-peptide (measured in nanomoles per liter (nmol/L)) from baseline (week 0) to week 26 is presented as ratio to baseline.', 'unitOfMeasure': 'Ratio of C-peptide', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants. Overall number of participants analysed = participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Insulin- Ratio to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.63', 'spread': '118.3', 'groupId': 'OG000'}, {'value': '0.50', 'spread': '106.4', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'Change in fasting insulin (measured in picomoles per liter (pmol/L)) from baseline (week 0) to week 26 is presented as ratio to baseline.', 'unitOfMeasure': 'Ratio of insulin', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants. Overall number of participants analysed = participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Glucagon- Ratio to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.01', 'spread': '95.8', 'groupId': 'OG000'}, {'value': '1.09', 'spread': '81.7', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'Change in fasting glucagon (measured in picograms per milliliter (pg/mL)) from baseline (week 0) to week 26 is presented as ratio to baseline.', 'unitOfMeasure': 'Ratio of glucagon', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants. Overall number of participants analysed = participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in HOMA-B (Beta-cell Function)- Ratio to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.47', 'spread': '115.0', 'groupId': 'OG000'}, {'value': '0.99', 'spread': '113.4', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'Change in HOMA-B from baseline (week 0) to week 26 is presented as ratio to baseline.', 'unitOfMeasure': 'Ratio of beta-cell function', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants. Overall number of participants analysed = participants with available data.'}, {'type': 'SECONDARY', 'title': 'Participants Who Achieved HbA1c < 7.0%, ADA Target (Yes/no)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '151', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '138', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 26', 'description': 'Participants who achieved HbA1c \\< 7.0%, ADA target (yes/no) is presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants. Overall number of participants analysed = participants with available data.'}, {'type': 'SECONDARY', 'title': 'Participants Who Achieved HbA1c ≤ 6.5%, American Association of Clinical Endocrinologists (AACE) Target (Yes/no)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '193', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 26', 'description': 'Participants who achieved HbA1c ≤ 6.5%, AACE target (yes/no) is presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants. Overall number of participants analysed = participants with available data.'}, {'type': 'SECONDARY', 'title': 'Participants Who Achieved HbA1c < 7.0% and Change From Baseline in Body Weight Below or Equal to Zero', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '98', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '204', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 26', 'description': 'Participants who achieved HbA1c \\< 7.0% and change from baseline in body weight below or equal to zero is presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants. Overall number of participants analysed = participants with available data.'}, {'type': 'SECONDARY', 'title': 'Participants Who Achieved HbA1c ≤ 6.5% and Change From Baseline in Body Weight Below or Equal to Zero', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '243', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 26', 'description': 'Participants who achieved HbA1c ≤ 6.5% and change from baseline in body weight below or equal to zero is presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants. Overall number of participants analysed = participants with available data.'}, {'type': 'SECONDARY', 'title': 'Participants Who Achieved HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Hypoglycaemic Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '148', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '154', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 26', 'description': 'Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value \\< 3.1 mmol/L with or without symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Participants who achieved HbA1c \\< 7.0% at week 26 without treatment-emergent severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment is presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants. Overall number of participants analysed = participants with available data.'}, {'type': 'SECONDARY', 'title': 'Participants Who Achieved HbA1c ≤ 6.5% Without Treatment-emergent Severe or BG Confirmed Hypoglycaemic Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '209', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 26', 'description': 'Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value \\< 3.1 mmol/L with or without symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Participants who achieved HbA1c ≤ 6.5% at week 26 without treatment-emergent severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment is presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants. Overall number of participants analysed = participants with available data.'}, {'type': 'SECONDARY', 'title': 'Participants Who Achieved HbA1c < 7.0% and Change From Baseline in Body Weight Below or Equal to Zero and Without Treatment-emergent Severe or BG Confirmed Hypoglycaemic Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '208', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 26', 'description': 'Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value \\< 3.1 mmol/L with or without symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Participants who achieved HbA1c \\< 7.0% and change from baseline in body weight below or equal to zero and without treatment-emergent severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment is presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants. Overall number of participants analysed = participants with available data.'}, {'type': 'SECONDARY', 'title': 'Participants Who Achieved HbA1c ≤ 6.5% and Change From Baseline in Body Weight Below or Equal to Zero and Without Treatment-emergent Severe or BG Confirmed Hypoglycaemic Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '244', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 26', 'description': 'Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value \\< 3.1 mmol/L with or without symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Participants who achieved HbA1c ≤ 6.5% and change from baseline in body weight below or equal to zero and without treatment-emergent severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment is presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants. Overall number of participants analysed = participants with available data.'}, {'type': 'SECONDARY', 'title': 'Number of Treatment-emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'categories': [{'measurements': [{'value': '641', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0-27', 'description': 'A TEAE was defined as an adverse event with 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. If the event had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last drug date, then this event was considered as a TEAE.', 'unitOfMeasure': 'Adverse events', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants who received at least one dose of IDegLira or IDeg.'}, {'type': 'SECONDARY', 'title': 'Number of Treatment-emergent Nocturnal Severe or BG Confirmed Hypoglycaemic Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0-27', 'description': 'Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value \\< 3.1 mmol/L with or without symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Nocturnal hypoglycaemic episodes were episodes occurring between 00:01 and 05.59 a.m. both inclusive. Number of treatment-emergent nocturnal severe or BG confirmed hypoglycaemic episodes is presented.', 'unitOfMeasure': 'Episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants who received at least one dose of IDegLira or IDeg.'}, {'type': 'SECONDARY', 'title': 'Number of Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0-27', 'description': 'Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value \\< 3.1 mmol/L with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes is presented.', 'unitOfMeasure': 'Episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants who received at least one dose of IDegLira or IDeg.'}, {'type': 'SECONDARY', 'title': 'Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0-27', 'description': 'Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value \\< 3.1 mmol/L with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Nocturnal hypoglycaemic episodes were episodes occurring between 00:01 and 05.59 a.m. both inclusive. Number of treatment-emergent nocturnal severe or BG confirmed symptomatic hypoglycaemic episodes is presented.', 'unitOfMeasure': 'Episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants who received at least one dose of IDegLira or IDeg.'}, {'type': 'SECONDARY', 'title': 'Number of Treatment-emergent Hypoglycaemic Episodes According to ADA Definition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'categories': [{'measurements': [{'value': '1099', 'groupId': 'OG000'}, {'value': '680', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0-27', 'description': 'Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Number of treatment-emergent hypoglycaemic episodes according to ADA definition is presented.', 'unitOfMeasure': 'Episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants who received at least one dose of IDegLira or IDeg.'}, {'type': 'SECONDARY', 'title': 'Change in Physical Examination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'title': 'Week-2: Cardiovascular system', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '299', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: Cardiovascular system', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '286', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Week-2: Central and peripheral nervous system', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '299', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: Central and peripheral nervous system', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '287', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week -2: Gastrointestinal system', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '299', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: Gastrointestinal system', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '285', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week -2: General appearance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '283', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: General appearance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '273', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Week -2: Head, eyes, ENTand Neck', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '295', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: Head, eyes, ENTand Neck', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '283', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Week -2: Lymph node palpation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '301', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: Lymph node palpation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '288', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week -2: Musculoskeletal system', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '296', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: Musculoskeletal system', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '280', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Week -2: Respiratory system', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '301', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: Respiratory system', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '288', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week -2: Skin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '270', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: Skin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '259', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Week -2: Thyroid gland', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '295', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: Thyroid gland', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '284', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week -2, week 26', 'description': 'Physical examination parameters are categorised as cardiovascular system; central and peripheral nervous system; gastrointestinal system including mouth; general appearance; head, ears, eyes, nose, throat, neck; lymph node palpation; musculoskeletal system; respiratory system; skin and thyroid gland. The number of participants assessed as normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS) at week -2 and week 26 is presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants who received at least one dose of IDegLira or IDeg. "Number analyzed"=participants with available data.'}, {'type': 'SECONDARY', 'title': 'Eye Examination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'title': 'Week -2: Left eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '167', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: Left eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '147', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '105', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}, {'title': 'Week -2: Right eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '162', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '98', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: Right eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '139', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '111', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week -2, week 26', 'description': 'Dilated fundoscopy or fundus photography was performed by the investigator at week -2 and week 26. The results of the examination were interpreted for each eye (left/right) are categorised as normal, abnormal NCS or abnormal CS. Number of participants in each category at week -2 and week 26 were presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants who received at least one dose of IDegLira or IDeg. "Number analyzed"=participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Electrocardiogram (ECG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'title': 'Week -2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '175', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '175', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week -2, week 26', 'description': 'The ECG was assessed by the investigator at baseline (week -2) and week 26 and categorised as normal, abnormal NCS or abnormal CS. Number of participants in each ECG category at baseline and week 26 were presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants who received at least one dose of IDegLira or IDeg. "Number analyzed"=participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Pulse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'spread': '9.6', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '8.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'Change in pulse from baseline (week 0) to week 26 is presented.', 'unitOfMeasure': 'Beats per minute (beats/min)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants who received at least one dose of IDegLira or IDeg. Overall number of participants analyzed = participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Blood Pressure (Systolic and Diastolic Blood Pressure)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'title': 'Systolic blood pressure', 'categories': [{'measurements': [{'value': '-3.5', 'spread': '13.6', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '12.5', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic blood pressure', 'categories': [{'measurements': [{'value': '0.1', 'spread': '7.8', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '8.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'Change in blood pressure (systolic and diastolic blood pressure) from baseline (week 0) to week 26 is presented.', 'unitOfMeasure': 'Millimeters of mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants who received at least one dose of IDegLira or IDeg. Overall number of participants analysed = participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Biochemical Parameter- Amylase, Lipase, Creatinine Kinase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'title': 'Amylase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.45', 'spread': '23.14', 'groupId': 'OG000'}, {'value': '2.69', 'spread': '11.72', 'groupId': 'OG001'}]}]}, {'title': 'Lipase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.97', 'spread': '35.24', 'groupId': 'OG000'}, {'value': '-0.35', 'spread': '13.81', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine kinase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.32', 'spread': '65.17', 'groupId': 'OG000'}, {'value': '6.99', 'spread': '84.31', 'groupId': 'OG001'}]}]}, {'title': 'ALT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.02', 'spread': '12.03', 'groupId': 'OG000'}, {'value': '-4.06', 'spread': '11.97', 'groupId': 'OG001'}]}]}, {'title': 'AST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.42', 'spread': '7.46', 'groupId': 'OG000'}, {'value': '-2.06', 'spread': '7.92', 'groupId': 'OG001'}]}]}, {'title': 'ALP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.62', 'spread': '13.30', 'groupId': 'OG000'}, {'value': '-1.70', 'spread': '11.39', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'Change in amylase, lipase, creatinine kinase, ALT, AST, ALP from baseline (week 0) to week 26 is presented.', 'unitOfMeasure': 'Units per liter (U/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants who received at least one dose of IDegLira or IDeg. Number analyzed = participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Biochemical Parameter-calcium (Total), Albumin Corrected Calcium, Potassium, Sodium, Urea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'title': 'Calcium (total)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'Albumin corrected calcium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.00', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Potassium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.34', 'groupId': 'OG000'}, {'value': '-0.11', 'spread': '0.35', 'groupId': 'OG001'}]}]}, {'title': 'Sodium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.03', 'spread': '2.47', 'groupId': 'OG000'}, {'value': '1.40', 'spread': '2.43', 'groupId': 'OG001'}]}]}, {'title': 'Urea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.09', 'spread': '1.32', 'groupId': 'OG000'}, {'value': '0.17', 'spread': '1.29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'Change in calcium (total), albumin corrected calcium, potassium, sodium, urea from baseline (week 0) to week 26 is presented.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants who received at least one dose of IDegLira or IDeg. Number analyzed = participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Albumin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.05', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'Change in albumin from baseline (week 0) to week 26 is presented.', 'unitOfMeasure': 'Grams per deciliter (g/dL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants who received at least one dose of IDegLira or IDeg. Overall number of participants analyzed = participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Total Bilirubin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.30', 'spread': '3.89', 'groupId': 'OG000'}, {'value': '-0.54', 'spread': '3.66', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'Change in total bilirubin from baseline (week 0) to week 26 is presented.', 'unitOfMeasure': 'Micromoles per liter (umol/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants who received at least one dose of IDegLira or IDeg. Overall number of participants analyzed = participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.44', 'spread': '7.93', 'groupId': 'OG000'}, {'value': '-0.32', 'spread': '7.52', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'Change in creatinine from baseline (week 0) to week 26 is presented.', 'unitOfMeasure': 'umol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants who received at least one dose of IDegLira or IDeg. Overall number of participants analyzed = participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Total Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.08', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.39', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'Change in total protein from baseline (week 0) to week 26 is presented.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants who received at least one dose of IDegLira or IDeg. Overall number of participants analyzed = participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Haematological Parameter- Haematocrit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.07', 'spread': '2.56', 'groupId': 'OG000'}, {'value': '-0.12', 'spread': '2.14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'Change in haematocrit from baseline (week 0) to week 26 is presented.', 'unitOfMeasure': 'Percentage of red blood cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants who received at least one dose of IDegLira or IDeg. Overall number of participants analyzed = participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Haematological Parameter- Haemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.08', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '-0.09', 'spread': '0.41', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'Change in haemoglobin from baseline (week 0) to week 26 is presented.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants who received at least one dose of IDegLira or IDeg. Overall number of participants analyzed = participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Haematological Parameter- Leukocytes and Thrombocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'title': 'Leukocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.32', 'spread': '1.39', 'groupId': 'OG000'}, {'value': '0.31', 'spread': '1.18', 'groupId': 'OG001'}]}]}, {'title': 'Thrombocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.13', 'spread': '34.34', 'groupId': 'OG000'}, {'value': '12.19', 'spread': '34.01', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'Change in leukocytes and thrombocytes from baseline (week 0) to week 26 is presented.', 'unitOfMeasure': '10^9 cells per liter (10^9/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants who received at least one dose of IDegLira or IDeg. Number of participants analyzed = participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Haematological Parameter- Erythrocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '-0.05', 'spread': '0.24', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'Change in erythrocytes from baseline (week 0) to week 26 is presented.', 'unitOfMeasure': '10^12 cells per liter (10^12/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants who received at least one dose of IDegLira or IDeg. Overall number of participants analyzed = participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Haematological Parameter- Basophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'spread': '0.34', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.27', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'Change in basophils from baseline (week 0) to week 26 is presented.', 'unitOfMeasure': 'Percentage of basophils', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants who received at least one dose of IDegLira or IDeg. Overall number of participants analyzed = participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Haematological Parameter- Eosinophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.15', 'spread': '1.84', 'groupId': 'OG000'}, {'value': '-0.25', 'spread': '1.72', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'Change in eosinophils from baseline (week 0) to week 26 is presented.', 'unitOfMeasure': 'Percentage of eosinophils', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants who received at least one dose of IDegLira or IDeg. Overall number of participants analyzed = participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Haematological Parameter- Lymphocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.00', 'spread': '6.95', 'groupId': 'OG000'}, {'value': '-0.82', 'spread': '6.41', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'Change in lymphocytes from baseline (week 0) to week 26 is presented.', 'unitOfMeasure': 'Percentage of lymphocytes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants who received at least one dose of IDegLira or IDeg. Overall number of participants analyzed = participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Haematological Parameter- Monocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.19', 'spread': '2.02', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '2.19', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'Change in monocytes from baseline (week 0) to week 26 is presented.', 'unitOfMeasure': 'Percentage of monocytes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants who received at least one dose of IDegLira or IDeg. Overall number of participants analyzed = participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Haematological Parameter- Neutrophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.34', 'spread': '7.85', 'groupId': 'OG000'}, {'value': '0.99', 'spread': '7.41', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'Change in neutrophils from baseline (week 0) to week 26 is presented.', 'unitOfMeasure': 'Percentage of neutrophils', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants who received at least one dose of IDegLira or IDeg. Overall number of participants analyzed = participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Calcitonin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'title': 'Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Low', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Normal', 'measurements': [{'value': '293', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}, {'title': 'High', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Low', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Normal', 'measurements': [{'value': '279', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}, {'title': 'High', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 0, week 26', 'description': 'Calcitonin levels were measured and were categorised as low, normal or high. Number of participants in each category at week 0 and week 26 were presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants who received at least one dose of IDegLira or IDeg. Number analyzed = participants with available data.'}, {'type': 'SECONDARY', 'title': 'Urinalysis (Erythrocytes, Protein, Glucose and Ketones)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'title': 'Week 0: Erythrocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Negative', 'measurements': [{'value': '258', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}, {'title': 'Trace', 'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}, {'title': '1+', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': '2+', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': '3+', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: Erythrocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Negative', 'measurements': [{'value': '255', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}, {'title': 'Trace', 'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': '1+', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': '2+', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': '3+', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Week 0: Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Negative', 'measurements': [{'value': '171', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}, {'title': 'Trace', 'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}, {'title': '1+', 'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}, {'title': '2+', 'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}, {'title': '3+', 'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Negative', 'measurements': [{'value': '256', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}, {'title': 'Trace', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}, {'title': '1+', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': '2+', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': '3+', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Week 0: Ketones', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Negative', 'measurements': [{'value': '274', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}, {'title': 'Trace', 'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': '1+', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': '2+', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': '3+', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: Ketones', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Negative', 'measurements': [{'value': '272', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}, {'title': 'Trace', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': '1+', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': '2+', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': '3+', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 0: Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Negative', 'measurements': [{'value': '172', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}, {'title': 'Trace', 'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}, {'title': '1+', 'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}, {'title': '2+', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': '3+', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Negative', 'measurements': [{'value': '198', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}, {'title': 'Trace', 'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}, {'title': '1+', 'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}, {'title': '2+', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': '3+', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 0, week 26', 'description': 'The urinalysis was the measurements of protein, glucose, erythrocytes and ketones at week 0 and week 26 and categorised as negative, trace, 1+, 2+ and 3+. Number of participants in each category at week 0 and week 26 are presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants who received at least one dose of IDegLira or IDeg. Number analyzed = participants with available data.'}, {'type': 'SECONDARY', 'title': 'Anti-insulin Degludec Specific Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.25', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '0.57', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 27', 'description': 'Serum samples were analysed for the presence of anti-insulin degludec specific antibodies. Results are presented as percentage of bound radioactivity-labelled insulin/total added radioactivity-labelled insulin (%B/T).', 'unitOfMeasure': '%B/T', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants who received at least one dose of IDegLira or IDeg. Overall number of participants analyzed = participants with available data.'}, {'type': 'SECONDARY', 'title': 'Antibodies Cross-reacting to Human Insulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.07', 'spread': '16.61', 'groupId': 'OG000'}, {'value': '8.64', 'spread': '16.84', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 27', 'description': 'Serum samples were analysed for the presence of antibodies cross-reacting to human insulin. Results are presented as percentage of bound radioactivity-labelled insulin/total added radioactivity-labelled insulin (%B/T).', 'unitOfMeasure': '%B/T', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants who received at least one dose of IDegLira or IDeg. Overall number of participants analyzed = participants with available data.'}, {'type': 'SECONDARY', 'title': 'Total Insulin Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.31', 'spread': '17.33', 'groupId': 'OG000'}, {'value': '8.77', 'spread': '17.19', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 27', 'description': 'Serum samples were analysed for the presence of total insulin antibodies. Results are presented as percentage of bound radioactivity-labelled insulin/total added radioactivity-labelled insulin (%B/T).', 'unitOfMeasure': '%B/T', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants who received at least one dose of IDegLira or IDeg. Overall number of participants analyzed = participants with available data.'}, {'type': 'SECONDARY', 'title': 'Occurrence of Anti-liraglutide Antibodies (Yes/no)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '24', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '264', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 27', 'description': 'This outcome measure is only applicable for the Insulin degludec/liraglutide treatment arm. Number of participants who measured with anti-liraglutide antibodies at week 27 are presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants who received at least one dose of IDegLira or IDeg. Overall number of participants analyzed = participants with available data.'}, {'type': 'SECONDARY', 'title': 'Occurrence of Anti-liraglutide Antibodies Cross Reacting Native Glucagon-like Peptide-1 (GLP-1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 27', 'description': 'This outcome measure is only applicable for the Insulin degludec/liraglutide treatment arm. Number of participants who measured with anti-liraglutide antibodies cross reacting native GLP-1 at week 27 are presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants who received at least one dose of IDegLira or IDeg. Overall number of participants analyzed = participants with available data.'}, {'type': 'SECONDARY', 'title': 'Occurrence of Neutralising Liraglutide Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 27', 'description': 'This outcome measure is only applicable for the Insulin degludec/liraglutide treatment arm. Number of participants who measured with neutralising liraglutide antibodies at week 27 are presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants who received at least one dose of IDegLira or IDeg. Overall number of participants analyzed = participants with available data.'}, {'type': 'SECONDARY', 'title': 'Occurrence of Neutralising Liraglutide Antibodies Cross Reacting Native GLP-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 27', 'description': 'This outcome measure is only applicable for the Insulin degludec/liraglutide treatment arm. Number of participants who measured with neutralising liraglutide antibodies cross reacting native GLP-1 at week 27 are presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants who received at least one dose of IDegLira or IDeg. Overall number of participants analyzed = participants with available data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'FG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '302'}, {'groupId': 'FG001', 'numSubjects': '151'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '301'}, {'groupId': 'FG001', 'numSubjects': '151'}]}, {'type': 'Full Analysis Set (FAS)', 'comment': 'FAS included all randomised participants.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '302'}, {'groupId': 'FG001', 'numSubjects': '151'}]}, {'type': 'Safety Analysis Set (SAS)', 'comment': 'SAS included all participants who received at least one dose of IDegLira or IDeg.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '301'}, {'groupId': 'FG001', 'numSubjects': '151'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '290'}, {'groupId': 'FG001', 'numSubjects': '139'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'The trial was conducted at 40 sites in China.', 'preAssignmentDetails': 'Participants were randomised in a 2:1 manner to receive either IDegLira or IDeg in combination with metformin.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '453', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.'}, {'id': 'BG001', 'title': 'Insulin Degludec', 'description': 'Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.5', 'spread': '9.8', 'groupId': 'BG000'}, {'value': '55.3', 'spread': '10.0', 'groupId': 'BG001'}, {'value': '54.7', 'spread': '9.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '119', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '179', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '183', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '274', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '302', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '453', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '302', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '453', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Glycosylated haemoglobin (HbA1c)', 'classes': [{'categories': [{'measurements': [{'value': '8.93', 'spread': '1.20', 'groupId': 'BG000'}, {'value': '8.96', 'spread': '1.17', 'groupId': 'BG001'}, {'value': '8.94', 'spread': '1.19', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percentage of HbA1c', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Full analysis set (FAS) included all randomised participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-01-23', 'size': 1149610, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-02-26T08:05', 'hasProtocol': False}, {'date': '2019-12-04', 'size': 1703799, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-02-26T08:05', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 453}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-04-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-18', 'studyFirstSubmitDate': '2017-05-24', 'resultsFirstSubmitDate': '2020-02-26', 'studyFirstSubmitQcDate': '2017-06-02', 'lastUpdatePostDateStruct': {'date': '2020-03-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-18', 'studyFirstPostDateStruct': {'date': '2017-06-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1c', 'timeFrame': 'Week 0, week 26', 'description': 'Change in glycosylated haemoglobin (HbA1c) from baseline (week 0) to week 26 is presented.'}], 'secondaryOutcomes': [{'measure': 'Change in Body Weight', 'timeFrame': 'Week 0, week 26', 'description': 'Change in body weight from baseline (week 0) to week 26 is presented.'}, {'measure': 'Number of Treatment-emergent Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes', 'timeFrame': 'Up to 26 weeks', 'description': 'Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification (requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value \\< 3.1 millimoles per liter (mmol/L) with or without symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Number of treatment-emergent severe or BG confirmed hypoglycaemic episodes during 26 weeks of treatment is presented.'}, {'measure': 'Change in Fasting Plasma Glucose (FPG)', 'timeFrame': 'Week 0, week 26', 'description': 'Change in FPG from baseline (week 0) to week 26 is presented.'}, {'measure': 'Change in Waist Circumference', 'timeFrame': 'Week 0, week 26', 'description': 'Change in waist circumference from baseline (week 0) to week 26 is presented.'}, {'measure': 'Change in Mean of the 9-point Self-measured Plasma Glucose (SMPG) Profile', 'timeFrame': 'Week 0, week 26', 'description': 'Participants measured plasma glucose values using the blood glucose meter at 9 time points: before breakfast, 90 min after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 min after start of dinner, bedtime, at 4:00 am and before breakfast the following day. The mean of profile is defined as the area under the profile divided by measurement time and is calculated using the trapezoidal method. Change in mean of the 9-point SMPG profile from baseline (week 0) to week 26 is presented.'}, {'measure': 'Change in SMPG-mean Post Prandial Increments', 'timeFrame': 'Week 0, week 26', 'description': 'Participants measured plasma glucose values using the blood glucose meter at 9 time points: before breakfast, 90 min after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 min after start of dinner, bedtime, at 4:00 am and before breakfast the following day. Change in SMPG-mean postprandial increment over all meals from baseline (week 0) to week 26 is presented.'}, {'measure': 'Insulin Dose', 'timeFrame': 'Week 26', 'description': 'The mean of actual daily total insulin dose after 26 weeks of treatment is presented.'}, {'measure': 'SMPG-9-point Profile (Individual Points in the Profile)', 'timeFrame': 'Week 26', 'description': 'Participants measured plasma glucose values using the blood glucose meter at 9 time points: before breakfast, 90 min after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 min after start of dinner, bedtime, at 4:00 am and before breakfast the following day. SMPG-9-point profile (individual points in the profile) at week 26 is presented.'}, {'measure': 'Change in Fasting High-density Lipoprotein (HDL) Cholesterol- Ratio to Baseline', 'timeFrame': 'Week 0, week 26', 'description': 'Change in fasting HDL cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline.'}, {'measure': 'Change in Fasting Low-density Lipoprotein (LDL) Cholesterol- Ratio to Baseline', 'timeFrame': 'Week 0, week 26', 'description': 'Change in fasting LDL cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline.'}, {'measure': 'Change in Fasting Very Low-density Lipoprotein (VLDL) Cholesterol- Ratio to Baseline', 'timeFrame': 'Week 0, week 26', 'description': 'Change in fasting VLDL cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline.'}, {'measure': 'Change in Fasting Total Cholesterol- Ratio to Baseline', 'timeFrame': 'Week 0, week 26', 'description': 'Change in fasting total cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline.'}, {'measure': 'Change in Fasting Triglycerides- Ratio to Baseline', 'timeFrame': 'Week 0, week 26', 'description': 'Change in fasting triglycerides (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline.'}, {'measure': 'Change in Fasting Free Fatty Acids- Ratio to Baseline', 'timeFrame': 'Week 0, week 26', 'description': 'Change in fasting free fatty acids (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline.'}, {'measure': 'Change in Fasting C-peptide- Ratio to Baseline', 'timeFrame': 'Week 0, week 26', 'description': 'Change in fasting C-peptide (measured in nanomoles per liter (nmol/L)) from baseline (week 0) to week 26 is presented as ratio to baseline.'}, {'measure': 'Change in Fasting Insulin- Ratio to Baseline', 'timeFrame': 'Week 0, week 26', 'description': 'Change in fasting insulin (measured in picomoles per liter (pmol/L)) from baseline (week 0) to week 26 is presented as ratio to baseline.'}, {'measure': 'Change in Fasting Glucagon- Ratio to Baseline', 'timeFrame': 'Week 0, week 26', 'description': 'Change in fasting glucagon (measured in picograms per milliliter (pg/mL)) from baseline (week 0) to week 26 is presented as ratio to baseline.'}, {'measure': 'Change in HOMA-B (Beta-cell Function)- Ratio to Baseline', 'timeFrame': 'Week 0, week 26', 'description': 'Change in HOMA-B from baseline (week 0) to week 26 is presented as ratio to baseline.'}, {'measure': 'Participants Who Achieved HbA1c < 7.0%, ADA Target (Yes/no)', 'timeFrame': 'Week 26', 'description': 'Participants who achieved HbA1c \\< 7.0%, ADA target (yes/no) is presented.'}, {'measure': 'Participants Who Achieved HbA1c ≤ 6.5%, American Association of Clinical Endocrinologists (AACE) Target (Yes/no)', 'timeFrame': 'Week 26', 'description': 'Participants who achieved HbA1c ≤ 6.5%, AACE target (yes/no) is presented.'}, {'measure': 'Participants Who Achieved HbA1c < 7.0% and Change From Baseline in Body Weight Below or Equal to Zero', 'timeFrame': 'Week 26', 'description': 'Participants who achieved HbA1c \\< 7.0% and change from baseline in body weight below or equal to zero is presented.'}, {'measure': 'Participants Who Achieved HbA1c ≤ 6.5% and Change From Baseline in Body Weight Below or Equal to Zero', 'timeFrame': 'Week 26', 'description': 'Participants who achieved HbA1c ≤ 6.5% and change from baseline in body weight below or equal to zero is presented.'}, {'measure': 'Participants Who Achieved HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Hypoglycaemic Episodes', 'timeFrame': 'Week 26', 'description': 'Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value \\< 3.1 mmol/L with or without symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Participants who achieved HbA1c \\< 7.0% at week 26 without treatment-emergent severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment is presented.'}, {'measure': 'Participants Who Achieved HbA1c ≤ 6.5% Without Treatment-emergent Severe or BG Confirmed Hypoglycaemic Episodes', 'timeFrame': 'Week 26', 'description': 'Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value \\< 3.1 mmol/L with or without symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Participants who achieved HbA1c ≤ 6.5% at week 26 without treatment-emergent severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment is presented.'}, {'measure': 'Participants Who Achieved HbA1c < 7.0% and Change From Baseline in Body Weight Below or Equal to Zero and Without Treatment-emergent Severe or BG Confirmed Hypoglycaemic Episodes', 'timeFrame': 'Week 26', 'description': 'Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value \\< 3.1 mmol/L with or without symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Participants who achieved HbA1c \\< 7.0% and change from baseline in body weight below or equal to zero and without treatment-emergent severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment is presented.'}, {'measure': 'Participants Who Achieved HbA1c ≤ 6.5% and Change From Baseline in Body Weight Below or Equal to Zero and Without Treatment-emergent Severe or BG Confirmed Hypoglycaemic Episodes', 'timeFrame': 'Week 26', 'description': 'Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value \\< 3.1 mmol/L with or without symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Participants who achieved HbA1c ≤ 6.5% and change from baseline in body weight below or equal to zero and without treatment-emergent severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment is presented.'}, {'measure': 'Number of Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'Weeks 0-27', 'description': 'A TEAE was defined as an adverse event with 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. If the event had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last drug date, then this event was considered as a TEAE.'}, {'measure': 'Number of Treatment-emergent Nocturnal Severe or BG Confirmed Hypoglycaemic Episodes', 'timeFrame': 'Weeks 0-27', 'description': 'Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value \\< 3.1 mmol/L with or without symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Nocturnal hypoglycaemic episodes were episodes occurring between 00:01 and 05.59 a.m. both inclusive. Number of treatment-emergent nocturnal severe or BG confirmed hypoglycaemic episodes is presented.'}, {'measure': 'Number of Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes', 'timeFrame': 'Weeks 0-27', 'description': 'Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value \\< 3.1 mmol/L with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes is presented.'}, {'measure': 'Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes', 'timeFrame': 'Weeks 0-27', 'description': 'Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value \\< 3.1 mmol/L with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Nocturnal hypoglycaemic episodes were episodes occurring between 00:01 and 05.59 a.m. both inclusive. Number of treatment-emergent nocturnal severe or BG confirmed symptomatic hypoglycaemic episodes is presented.'}, {'measure': 'Number of Treatment-emergent Hypoglycaemic Episodes According to ADA Definition', 'timeFrame': 'Weeks 0-27', 'description': 'Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Number of treatment-emergent hypoglycaemic episodes according to ADA definition is presented.'}, {'measure': 'Change in Physical Examination', 'timeFrame': 'Week -2, week 26', 'description': 'Physical examination parameters are categorised as cardiovascular system; central and peripheral nervous system; gastrointestinal system including mouth; general appearance; head, ears, eyes, nose, throat, neck; lymph node palpation; musculoskeletal system; respiratory system; skin and thyroid gland. The number of participants assessed as normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS) at week -2 and week 26 is presented.'}, {'measure': 'Eye Examination', 'timeFrame': 'Week -2, week 26', 'description': 'Dilated fundoscopy or fundus photography was performed by the investigator at week -2 and week 26. The results of the examination were interpreted for each eye (left/right) are categorised as normal, abnormal NCS or abnormal CS. Number of participants in each category at week -2 and week 26 were presented.'}, {'measure': 'Change in Electrocardiogram (ECG)', 'timeFrame': 'Week -2, week 26', 'description': 'The ECG was assessed by the investigator at baseline (week -2) and week 26 and categorised as normal, abnormal NCS or abnormal CS. Number of participants in each ECG category at baseline and week 26 were presented.'}, {'measure': 'Change in Pulse', 'timeFrame': 'Week 0, week 26', 'description': 'Change in pulse from baseline (week 0) to week 26 is presented.'}, {'measure': 'Change in Blood Pressure (Systolic and Diastolic Blood Pressure)', 'timeFrame': 'Week 0, week 26', 'description': 'Change in blood pressure (systolic and diastolic blood pressure) from baseline (week 0) to week 26 is presented.'}, {'measure': 'Change in Biochemical Parameter- Amylase, Lipase, Creatinine Kinase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)', 'timeFrame': 'Week 0, week 26', 'description': 'Change in amylase, lipase, creatinine kinase, ALT, AST, ALP from baseline (week 0) to week 26 is presented.'}, {'measure': 'Change in Biochemical Parameter-calcium (Total), Albumin Corrected Calcium, Potassium, Sodium, Urea', 'timeFrame': 'Week 0, week 26', 'description': 'Change in calcium (total), albumin corrected calcium, potassium, sodium, urea from baseline (week 0) to week 26 is presented.'}, {'measure': 'Change in Albumin', 'timeFrame': 'Week 0, week 26', 'description': 'Change in albumin from baseline (week 0) to week 26 is presented.'}, {'measure': 'Change in Total Bilirubin', 'timeFrame': 'Week 0, week 26', 'description': 'Change in total bilirubin from baseline (week 0) to week 26 is presented.'}, {'measure': 'Change in Creatinine', 'timeFrame': 'Week 0, week 26', 'description': 'Change in creatinine from baseline (week 0) to week 26 is presented.'}, {'measure': 'Change in Total Protein', 'timeFrame': 'Week 0, week 26', 'description': 'Change in total protein from baseline (week 0) to week 26 is presented.'}, {'measure': 'Change in Haematological Parameter- Haematocrit', 'timeFrame': 'Week 0, week 26', 'description': 'Change in haematocrit from baseline (week 0) to week 26 is presented.'}, {'measure': 'Change in Haematological Parameter- Haemoglobin', 'timeFrame': 'Week 0, week 26', 'description': 'Change in haemoglobin from baseline (week 0) to week 26 is presented.'}, {'measure': 'Change in Haematological Parameter- Leukocytes and Thrombocytes', 'timeFrame': 'Week 0, week 26', 'description': 'Change in leukocytes and thrombocytes from baseline (week 0) to week 26 is presented.'}, {'measure': 'Change in Haematological Parameter- Erythrocytes', 'timeFrame': 'Week 0, week 26', 'description': 'Change in erythrocytes from baseline (week 0) to week 26 is presented.'}, {'measure': 'Change in Haematological Parameter- Basophils', 'timeFrame': 'Week 0, week 26', 'description': 'Change in basophils from baseline (week 0) to week 26 is presented.'}, {'measure': 'Change in Haematological Parameter- Eosinophils', 'timeFrame': 'Week 0, week 26', 'description': 'Change in eosinophils from baseline (week 0) to week 26 is presented.'}, {'measure': 'Change in Haematological Parameter- Lymphocytes', 'timeFrame': 'Week 0, week 26', 'description': 'Change in lymphocytes from baseline (week 0) to week 26 is presented.'}, {'measure': 'Change in Haematological Parameter- Monocytes', 'timeFrame': 'Week 0, week 26', 'description': 'Change in monocytes from baseline (week 0) to week 26 is presented.'}, {'measure': 'Change in Haematological Parameter- Neutrophils', 'timeFrame': 'Week 0, week 26', 'description': 'Change in neutrophils from baseline (week 0) to week 26 is presented.'}, {'measure': 'Change in Calcitonin', 'timeFrame': 'Week 0, week 26', 'description': 'Calcitonin levels were measured and were categorised as low, normal or high. Number of participants in each category at week 0 and week 26 were presented.'}, {'measure': 'Urinalysis (Erythrocytes, Protein, Glucose and Ketones)', 'timeFrame': 'Week 0, week 26', 'description': 'The urinalysis was the measurements of protein, glucose, erythrocytes and ketones at week 0 and week 26 and categorised as negative, trace, 1+, 2+ and 3+. Number of participants in each category at week 0 and week 26 are presented.'}, {'measure': 'Anti-insulin Degludec Specific Antibodies', 'timeFrame': 'Week 27', 'description': 'Serum samples were analysed for the presence of anti-insulin degludec specific antibodies. Results are presented as percentage of bound radioactivity-labelled insulin/total added radioactivity-labelled insulin (%B/T).'}, {'measure': 'Antibodies Cross-reacting to Human Insulin', 'timeFrame': 'Week 27', 'description': 'Serum samples were analysed for the presence of antibodies cross-reacting to human insulin. Results are presented as percentage of bound radioactivity-labelled insulin/total added radioactivity-labelled insulin (%B/T).'}, {'measure': 'Total Insulin Antibodies', 'timeFrame': 'Week 27', 'description': 'Serum samples were analysed for the presence of total insulin antibodies. Results are presented as percentage of bound radioactivity-labelled insulin/total added radioactivity-labelled insulin (%B/T).'}, {'measure': 'Occurrence of Anti-liraglutide Antibodies (Yes/no)', 'timeFrame': 'Week 27', 'description': 'This outcome measure is only applicable for the Insulin degludec/liraglutide treatment arm. Number of participants who measured with anti-liraglutide antibodies at week 27 are presented.'}, {'measure': 'Occurrence of Anti-liraglutide Antibodies Cross Reacting Native Glucagon-like Peptide-1 (GLP-1)', 'timeFrame': 'Week 27', 'description': 'This outcome measure is only applicable for the Insulin degludec/liraglutide treatment arm. Number of participants who measured with anti-liraglutide antibodies cross reacting native GLP-1 at week 27 are presented.'}, {'measure': 'Occurrence of Neutralising Liraglutide Antibodies', 'timeFrame': 'Week 27', 'description': 'This outcome measure is only applicable for the Insulin degludec/liraglutide treatment arm. Number of participants who measured with neutralising liraglutide antibodies at week 27 are presented.'}, {'measure': 'Occurrence of Neutralising Liraglutide Antibodies Cross Reacting Native GLP-1', 'timeFrame': 'Week 27', 'description': 'This outcome measure is only applicable for the Insulin degludec/liraglutide treatment arm. Number of participants who measured with neutralising liraglutide antibodies cross reacting native GLP-1 at week 27 are presented.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Asia. The aim of this trial is to confirm the superiority of insulin degludec/liraglutide versus insulin degludec in controlling glycaemia in Chinese subjects with type 2 diabetes mellitus after 26 weeks of treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including procedures to determine suitability for the trial - Male or female, age at least 18 years at the time of signing inform consent - Type 2 diabetes mellitus (clinically diagnosed) - HbA1c (glycosylated haemoglobin) above or equal to 7.5% by central laboratory analysis, with the aim of a median of 8.5%. When approximately 50% of the randomised subjects have an HbA1c above 8.5%, the remaining subjects randomised must have an HbA1c below or equal to 8.5% or when approximately 50% of the subjects randomised have an HbA1c below or equal to 8.5%, the remaining subjects randomised must have an HbA1c above 8.5% - Current treatment for at least 90 calendar days prior to screening with basal insulin plus metformin plus/minus α-glucosidase inhibitors, sulphonylureas, glinides or thiazolidinediones. Subjects should be on a stable dose for at least 60 calendar days prior to screening of: Basal insulin 20-50 units (U)/day (both inclusive) ( Individual fluctuations of plus/minus 5U during the 60 day period prior to the day of screening are acceptable.) on the day of screening in combination with: - Metformin (above or equal to 1500 mg or max tolerated dose) or - Metformin (above or equal to 1500 mg or max tolerated dose) and sulphonylureas (above or equal to half of the max approved dose according to local label) or - Metformin (above or equal to 1500 mg or max tolerated dose) and glinide (at least half of the max approved dose according to local label) or - Metformin (above or equal to 1500 mg or max tolerated dose) and α-glucosidase inhibitors (AGI) (at least half of the max approved dose according to local label) or - Metformin (above or equal to 1500 mg or max tolerated dose) and thiazolidinediones (at least half of the max approved dose according to local label) - Body mass index (BMI) above or equal to 24 kg/m\\^2 Exclusion Criteria: Current use of any antidiabetic drug (except for basal insulin, metformin, α-glucosidase inhibitors, sulphonylureas, glinides or thiazolidinediones) or anticipated change in concomitant medication, that in the investigator´s opinion could interfere with glucose level (e.g. systemic corticosteroids) - Treatment with glucagon like peptide -1 receptor agonists, or dipeptidyl-peptidase-4 inhibitors or insulin (except for basal insulin) within 90 days prior to Visit 1 - Impaired liver function defined as alanine aminotransferase above or equal to 2.5 times upper normal range - Impaired renal function defined as serum-creatinine above or equal to 133 μmol/L for males and above or equal to 125 μmol/L for females, or as defined according to local contraindications for metformin Screening calcitonin above or equal to 50 ng/L - Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2) - Cardiac disorder defined as: congestive heart failure (NYHA class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the last 12 months prior to screening and/or planned coronary, carotid or peripheral artery revascularisation procedures - Severe uncontrolled treated or untreated hypertension (systolic blood pressure above or equal to 180 mm Hg or diastolic blood pressure above or equal to 100 mm Hg) - Proliferative retinopathy or maculopathy (macular oedema) requiring acute treatment - History of pancreatitis (acute or chronic)'}, 'identificationModule': {'nctId': 'NCT03175120', 'acronym': 'DUAL™ II China', 'briefTitle': 'A Trial Comparing Insulin Degludec/Liraglutide and Insulin Degludec in Combination With Metformin in Chinese Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin Therapy and Metformin With or Without One Other Oral Antidiabetic Drug (OAD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide and Insulin Degludec in Combination With Metformin in Chinese Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin Therapy and Metformin With or Without One Other OAD', 'orgStudyIdInfo': {'id': 'NN9068-4166'}, 'secondaryIdInfos': [{'id': 'U1111-1154-6732', 'type': 'OTHER', 'domain': 'World Health Organization (WHO)'}, {'id': 'CTR20060909', 'type': 'REGISTRY', 'domain': 'China Drug Trials (China)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Insulin degludec/liraglutide', 'interventionNames': ['Drug: Insulin degludec/liraglutide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Insulin degludec', 'interventionNames': ['Drug: Insulin degludec']}], 'interventions': [{'name': 'Insulin degludec/liraglutide', 'type': 'DRUG', 'description': 'Administered subcutaneously (s.c., under the skin) once daily in combination with metformin for the treatment duration of 26 weeks.', 'armGroupLabels': ['Insulin degludec/liraglutide']}, {'name': 'Insulin degludec', 'type': 'DRUG', 'description': 'Administered subcutaneously (s.c., under the skin) once daily in combination with metformin for the treatment duration of 26 weeks.', 'armGroupLabels': ['Insulin degludec']}]}, 'contactsLocationsModule': {'locations': [{'zip': '230001', 'city': 'Hefei', 'state': 'Anhui', 'country': 'China', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'zip': '230061', 'city': 'Hefei', 'state': 'Anhui', 'country': 'China', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'zip': '100071', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100088', 'city': 'Beijing', 'state': 'Beijing 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