Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2026-02-24 @ 7:49 AM
Study NCT ID:
NCT02501161
Status:
COMPLETED
Last Update Posted:
2019-11-27
First Post:
2015-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A 104 Week Clinical Trial Comparing Long Term Glycaemic Control of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine Therapy in Subjects With Type 2 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'D000069036', 'term': 'Insulin Glargine'}], 'ancestors': [{'id': 'D049528', 'term': 'Insulin, Long-Acting'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@novonordisk.com', 'phone': '(+1) 866-867-7178', 'title': 'Clinical Reporting Anchor and Disclosure (1452)', 'organization': 'Novo Nordisk A/S'}, 'certainAgreement': {'otherDetails': 'At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2', '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 receiving at least one dose of trial product.', 'eventGroups': [{'id': 'EG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).', 'otherNumAtRisk': 506, 'deathsNumAtRisk': 506, 'otherNumAffected': 206, 'seriousNumAtRisk': 506, 'deathsNumAffected': 2, 'seriousNumAffected': 60}, {'id': 'EG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.', 'otherNumAtRisk': 504, 'deathsNumAtRisk': 504, 'otherNumAffected': 156, 'seriousNumAtRisk': 504, 'deathsNumAffected': 5, 'seriousNumAffected': 43}], 'otherEvents': [{'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 27, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 36, 'numAffected': 29}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 30, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 40, 'numAffected': 27}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 52, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 14, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 98, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 89, 'numAffected': 45}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 46, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 38, 'numAffected': 28}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 71, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 53, 'numAffected': 44}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 39, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 30, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 44, 'numAffected': 36}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}], 'seriousEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Benign hepatic neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Cervicobrachial syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Cholecystitis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Coronary arterial stent insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Craniocerebral injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Dacryocystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Diabetic foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Diabetic retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Electrocardiogram abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Gastroduodenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Gun shot wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Helicobacter gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Ilium fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Invasive ductal breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Irritable bowel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Lung perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Macular degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Metrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Nerve injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Oesophageal adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Ovarian cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Percutaneous coronary intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Peripheral arterial reocclusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Peripheral artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Postoperative respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Respiratory fume inhalation disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Squamous cell carcinoma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Stab wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Streptococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Tympanoplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Uterine cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Vascular pseudoaneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Vasoconstriction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Vertebrobasilar insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 504, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time From Randomisation to Inadequate Glycaemic Control and Need for Treatment Intensification', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.'}], 'classes': [{'title': 'Baseline HbA1c <8.5% + Non-SU users', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'The estimated median and 75 percentile data were not available as the proportions were not reached within study period.', 'groupId': 'OG000', 'lowerLimit': '104.0', 'upperLimit': 'NA'}, {'value': '104.3', 'comment': 'The 75 percentile data was not available as the proportions was not reached within study period.', 'groupId': 'OG001', 'lowerLimit': '38.1', 'upperLimit': 'NA'}]}]}, {'title': 'Baseline HbA1c <8.5% + SU users', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '106.7', 'comment': 'The 75 percentile data was not available as the proportions was not reached within study period.', 'groupId': 'OG000', 'lowerLimit': '89.9', 'upperLimit': 'NA'}, {'value': '90.3', 'groupId': 'OG001', 'lowerLimit': '26.4', 'upperLimit': '105.1'}]}]}, {'title': 'Baseline HbA1c >=8.5% + Non-SU users', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'The estimated median and 75 percentile data were not available as the proportions were not reached within study period.', 'groupId': 'OG000', 'lowerLimit': '39.7', 'upperLimit': 'NA'}, {'value': '64.6', 'groupId': 'OG001', 'lowerLimit': '26.1', 'upperLimit': '105.1'}]}]}, {'title': 'Baseline HbA1c >=8.5% + SU users', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '104.0', 'comment': 'The 75 percentile data was not available as the proportions was not reached within study period.', 'groupId': 'OG000', 'lowerLimit': '26.4', 'upperLimit': 'NA'}, {'value': '26.6', 'groupId': 'OG001', 'lowerLimit': '26.1', 'upperLimit': '91.1'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Test for no treatment difference was based on using a stratified log-rank test where treatment, baseline HbA1c group and pre-trial OAD treatment group were included as strata in the model.', 'statisticalMethod': 'Stratified log-rank test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Weeks 0-104 + 7 days follow-up-1 + 30 days follow-up-2', 'description': 'Inadequate glycaemic control and need for treatment intensification was defined as a glycosylated haemoglobin (HbA1c) of 7.0% or greater at 2 consecutive visits from week 26, including week 26 if HbA1c was greater than or equal to 7% at week 12. Time from randomisation to inadequate glycaemic control and need for treatment intensification was analysed using a stratified log-rank test where treatment, baseline HbA1c group and previous OAD treatment were included as strata in the model. The variable "baseline HbA1c group" was a dichotomised baseline HbA1c variable with 2 categories: HbA1c \\< 8.5% or HbA1c ≥ 8.5% and the variable "previous OAD treatment" was a categorical variable with 2 categories: SU ± OAD(s) (SU users) or OAD(s) (Non-SU users). 25%, median (50%) and 75% percentiles for the cumulative distribution function were obtained from the Kaplan-Meier survival function.', 'unitOfMeasure': 'Weeks', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants. Number analyzed=participants in the specified category.'}, {'type': 'SECONDARY', 'title': 'Time From Randomisation to HbA1c >6.5% at 2 Consecutive Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.'}], 'classes': [{'title': 'Baseline HbA1c <8.5% + Non-SU users', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'The estimated median and 75 percentile data were not available as the proportions were not reached within study period.', 'groupId': 'OG000', 'lowerLimit': '52.1', 'upperLimit': 'NA'}, {'value': '64.1', 'groupId': 'OG001', 'lowerLimit': '26.1', 'upperLimit': '104.3'}]}]}, {'title': 'Baseline HbA1c <8.5% + SU users', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '90.1', 'comment': 'The 75 percentile data was not available as the proportion was not reached within study period.', 'groupId': 'OG000', 'lowerLimit': '27.0', 'upperLimit': 'NA'}, {'value': '26.6', 'groupId': 'OG001', 'lowerLimit': '26.1', 'upperLimit': '89.9'}]}]}, {'title': 'Baseline HbA1c >=8.5% + Non-SU users', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '64.1', 'comment': 'The 75 percentile data was not available as the proportion was not reached within study period.', 'groupId': 'OG000', 'lowerLimit': '26.1', 'upperLimit': 'NA'}, {'value': '26.6', 'groupId': 'OG001', 'lowerLimit': '26.1', 'upperLimit': '90.1'}]}]}, {'title': 'Baseline HbA1c >=8.5% + SU users', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52.1', 'groupId': 'OG000', 'lowerLimit': '26.1', 'upperLimit': '104.1'}, {'value': '26.1', 'groupId': 'OG001', 'lowerLimit': '26.1', 'upperLimit': '38.1'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Test for no treatment difference was based on using a stratified log-rank test where treatment, baseline HbA1c group and pre-trial OAD treatment group were included as strata in the model.', 'statisticalMethod': 'Stratified log-rank test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Weeks 0-104 + 7 days follow-up-1 + 30 days follow-up-2', 'description': 'Time to HbA1c \\> 6.5% at 2 consecutive visits is defined as time from randomization to HbA1c \\> 6.5% at 2 consecutive planned scheduled visits from week 26 (including week 26 if HbA1c was \\> 6.5% at week 12). Time from randomisation to HbA1c \\>6.5% at 2 consecutive visits was analysed using a stratified log-rank test where treatment, baseline HbA1c group and previous OAD treatment were included as strata in the model. The variable "baseline HbA1c group" was a dichotomised baseline HbA1c variable with 2 categories: HbA1c \\< 8.5% or HbA1c ≥ 8.5% and the variable "previous OAD treatment" was a categorical variable with 2 categories: SU ± OAD(s) (SU users) or OAD(s) (Non-SU users). 25%, median (50%) and 75% percentiles for the cumulative distribution function were obtained from the Kaplan-Meier survival function.', 'unitOfMeasure': 'Weeks', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants. Number analyzed=participants with event.'}, {'type': 'SECONDARY', 'title': 'Change in HbA1c', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.99', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '-1.69', 'spread': '1.10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26', 'description': 'Change in HbA1c from baseline (week 0) to week 26 is presented.', 'unitOfMeasure': 'Percentage of HbA1c', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Number analyzed'=participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '481', 'groupId': 'OG000'}, {'value': '466', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '3.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.2', 'spread': '4.9', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '4.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26, week 104', 'description': 'Change in body weight from baseline (week 0) to week 26 and week 104 is presented.', 'unitOfMeasure': 'Kilogram (kg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Number analyzed'=participants with available data."}, {'type': 'SECONDARY', 'title': 'Insulin Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '504', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '476', 'groupId': 'OG000'}, {'value': '449', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34.6', 'spread': '13.4', 'groupId': 'OG000'}, {'value': '48.6', 'spread': '28.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.1', 'spread': '12.9', 'groupId': 'OG000'}, {'value': '50.6', 'spread': '31.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 26, week 104', 'description': 'Insulin dose after 26 and 104 weeks of treatment is presented.', 'unitOfMeasure': 'Units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Safety analysis set (SAS) included all participants receiving at least 1 dose of the investigational product (IDegLira) or comparator (IGlar). 'Number analyzed'=participants with available data."}, {'type': 'SECONDARY', 'title': 'Participants Who Achieved (Yes/no): HbA1c <7.0%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.'}], 'classes': [{'title': 'Week 26: Yes', 'categories': [{'measurements': [{'value': '78.7', 'groupId': 'OG000'}, {'value': '55.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: No', 'categories': [{'measurements': [{'value': '21.3', 'groupId': 'OG000'}, {'value': '44.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 104: Yes', 'categories': [{'measurements': [{'value': '55.5', 'groupId': 'OG000'}, {'value': '28.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 104: No', 'categories': [{'measurements': [{'value': '44.5', 'groupId': 'OG000'}, {'value': '71.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 26, week 104', 'description': 'Percentage of participants who achieved (yes/no) HbA1c \\<7.0% at week 26 and week 104 is presented.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Number analyzed'=participants with available data."}, {'type': 'SECONDARY', 'title': 'Participants Who Achieved (Yes/no): HbA1c <7.0% Without Weight Gain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.'}], 'classes': [{'title': 'Week 26: Yes', 'categories': [{'measurements': [{'value': '38.5', 'groupId': 'OG000'}, {'value': '15.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: No', 'categories': [{'measurements': [{'value': '61.5', 'groupId': 'OG000'}, {'value': '84.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 104: Yes', 'categories': [{'measurements': [{'value': '20.9', 'groupId': 'OG000'}, {'value': '6.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 104: No', 'categories': [{'measurements': [{'value': '79.1', 'groupId': 'OG000'}, {'value': '93.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 26, week 104', 'description': 'Percentage of participants who achieved (yes/no) HbA1c \\<7.0% without weight gain at week 26 and week 104 is presented.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Number analyzed'=participants with available data."}, {'type': 'SECONDARY', 'title': 'Participants Who Achieved (Yes/no): HbA1c <7.0% Without Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.'}], 'classes': [{'title': 'Week 26: Yes', 'categories': [{'measurements': [{'value': '71.3', 'groupId': 'OG000'}, {'value': '44.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: No', 'categories': [{'measurements': [{'value': '28.7', 'groupId': 'OG000'}, {'value': '55.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 104: Yes', 'categories': [{'measurements': [{'value': '51.8', 'groupId': 'OG000'}, {'value': '25.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 104: No', 'categories': [{'measurements': [{'value': '48.2', 'groupId': 'OG000'}, {'value': '74.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 26, week 104', 'description': 'Severe or BG confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the American Diabetes Association (ADA) classification or BG confirmed by a plasma glucose value \\<3.1 mmol/L (56 mg/dL) 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. Percentage of participants who achieved (yes/no) HbA1c \\<7.0% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes at week 26 and week 104 is presented.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Number analyzed'=participants with available data."}, {'type': 'SECONDARY', 'title': 'Participants Who Achieved (Yes/no): HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.'}], 'classes': [{'title': 'Week 26: Yes', 'categories': [{'measurements': [{'value': '35.2', 'groupId': 'OG000'}, {'value': '13.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: No', 'categories': [{'measurements': [{'value': '64.8', 'groupId': 'OG000'}, {'value': '86.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 104: Yes', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '6.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 104: No', 'categories': [{'measurements': [{'value': '80.0', 'groupId': 'OG000'}, {'value': '93.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 26, week 104', 'description': 'Severe or BG confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the ADA classification or BG confirmed by a plasma glucose value \\<3.1 mmol/L (56 mg/dL) 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. Percentage of participants who achieved (yes/no) HbA1c \\<7.0% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes and without weight gain at week 26 and week 104 is presented.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Number analyzed'=participants with available data."}, {'type': 'SECONDARY', 'title': 'Participants Who Achieved (Yes/no): HbA1c ≤6.5%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.'}], 'classes': [{'title': 'Week 26: Yes', 'categories': [{'measurements': [{'value': '63.6', 'groupId': 'OG000'}, {'value': '35.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: No', 'categories': [{'measurements': [{'value': '36.4', 'groupId': 'OG000'}, {'value': '64.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 104: Yes', 'categories': [{'measurements': [{'value': '43.3', 'groupId': 'OG000'}, {'value': '21.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 104: No', 'categories': [{'measurements': [{'value': '56.7', 'groupId': 'OG000'}, {'value': '78.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 26, week 104', 'description': 'Percentage of participants who achieved (yes/no) HbA1c ≤6.5% at week 26 and week 104 is presented.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Number analyzed'=participants with available data."}, {'type': 'SECONDARY', 'title': 'Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Weight Gain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.'}], 'classes': [{'title': 'Week 26: Yes', 'categories': [{'measurements': [{'value': '33.2', 'groupId': 'OG000'}, {'value': '9.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: No', 'categories': [{'measurements': [{'value': '66.8', 'groupId': 'OG000'}, {'value': '90.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 104: Yes', 'categories': [{'measurements': [{'value': '17.6', 'groupId': 'OG000'}, {'value': '5.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 104: No', 'categories': [{'measurements': [{'value': '82.4', 'groupId': 'OG000'}, {'value': '94.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 26, week 104', 'description': 'Percentage of participants who achieved (yes/no) HbA1c ≤6.5% without weight gain at week 26 and week 104 is presented.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Number analyzed'=participants with available data."}, {'type': 'SECONDARY', 'title': 'Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.'}], 'classes': [{'title': 'Week 26: Yes', 'categories': [{'measurements': [{'value': '57.9', 'groupId': 'OG000'}, {'value': '27.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: No', 'categories': [{'measurements': [{'value': '42.1', 'groupId': 'OG000'}, {'value': '72.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 104: Yes', 'categories': [{'measurements': [{'value': '40.1', 'groupId': 'OG000'}, {'value': '19.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 104: No', 'categories': [{'measurements': [{'value': '59.9', 'groupId': 'OG000'}, {'value': '80.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 26, week 104', 'description': 'Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value \\<3.1 mmol/L (56 mg/dL) 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. Percentage of participants who achieved (yes/no) HbA1c ≤6.5% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes at week 26 and week 104 is presented.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Number analyzed'=participants with available data."}, {'type': 'SECONDARY', 'title': 'Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.'}], 'classes': [{'title': 'Week 26: Yes', 'categories': [{'measurements': [{'value': '30.2', 'groupId': 'OG000'}, {'value': '8.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: No', 'categories': [{'measurements': [{'value': '69.8', 'groupId': 'OG000'}, {'value': '91.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 104: Yes', 'categories': [{'measurements': [{'value': '16.6', 'groupId': 'OG000'}, {'value': '5.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 104: No', 'categories': [{'measurements': [{'value': '83.4', 'groupId': 'OG000'}, {'value': '94.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 26, week 104', 'description': 'Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value \\<3.1 mmol/L (56 mg/dL) 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. Percentage of participants who achieved (yes/no) HbA1c ≤6.5% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes and without weight gain at week 26 and week 104 is presented.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Number analyzed'=participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in FPG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '475', 'groupId': 'OG000'}, {'value': '461', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.97', 'spread': '3.06', 'groupId': 'OG000'}, {'value': '-3.79', 'spread': '3.18', 'groupId': 'OG001'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '328', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.93', 'spread': '2.96', 'groupId': 'OG000'}, {'value': '-3.73', 'spread': '2.75', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26, week 104', 'description': 'Change in fasting plasma glucose (FPG) from baseline (week 0) to week 26 and week 104 is presented.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Number analyzed'=participants with available data."}, {'type': 'SECONDARY', 'title': 'SMPG-9-point Profile (Individual Points in the Profile)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.'}], 'classes': [{'title': 'Week 26: Before breakfast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '437', 'groupId': 'OG000'}, {'value': '413', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.59', 'spread': '1.57', 'groupId': 'OG000'}, {'value': '5.58', 'spread': '1.58', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: 90 minutes after breakfast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '425', 'groupId': 'OG000'}, {'value': '409', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.34', 'spread': '2.62', 'groupId': 'OG000'}, {'value': '8.76', 'spread': '2.68', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: Before lunch', 'denoms': [{'units': 'Participants', 'counts': [{'value': '435', 'groupId': 'OG000'}, {'value': '407', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.03', 'spread': '2.00', 'groupId': 'OG000'}, {'value': '6.43', 'spread': '2.24', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: 90 minutes after lunch', 'denoms': [{'units': 'Participants', 'counts': [{'value': '433', 'groupId': 'OG000'}, {'value': '407', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.02', 'spread': '2.32', 'groupId': 'OG000'}, {'value': '8.79', 'spread': '2.64', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: Before dinner', 'denoms': [{'units': 'Participants', 'counts': [{'value': '434', 'groupId': 'OG000'}, {'value': '408', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.67', 'spread': '2.26', 'groupId': 'OG000'}, {'value': '6.91', 'spread': '2.35', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: 90 minutes after dinner', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '406', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.31', 'spread': '2.47', 'groupId': 'OG000'}, {'value': '9.10', 'spread': '2.70', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: Bedtime', 'denoms': [{'units': 'Participants', 'counts': [{'value': '423', 'groupId': 'OG000'}, {'value': '398', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.48', 'spread': '2.42', 'groupId': 'OG000'}, {'value': '8.13', 'spread': '2.68', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: At 4:00 a.m.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'OG000'}, {'value': '398', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.72', 'spread': '1.55', 'groupId': 'OG000'}, {'value': '5.91', 'spread': '1.99', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: Before breakfast the following day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '433', 'groupId': 'OG000'}, {'value': '403', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.53', 'spread': '1.37', 'groupId': 'OG000'}, {'value': '5.56', 'spread': '1.56', 'groupId': 'OG001'}]}]}, {'title': 'Week 104: Before breakfast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.58', 'spread': '1.38', 'groupId': 'OG000'}, {'value': '5.57', 'spread': '1.27', 'groupId': 'OG001'}]}]}, {'title': 'Week 104: 90 minutes after breakfast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.99', 'spread': '2.50', 'groupId': 'OG000'}, {'value': '8.64', 'spread': '2.59', 'groupId': 'OG001'}]}]}, {'title': 'Week 104: Before lunch', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.06', 'spread': '1.91', 'groupId': 'OG000'}, {'value': '6.37', 'spread': '2.02', 'groupId': 'OG001'}]}]}, {'title': 'Week 104: 90 minutes after lunch', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.80', 'spread': '2.16', 'groupId': 'OG000'}, {'value': '8.87', 'spread': '2.45', 'groupId': 'OG001'}]}]}, {'title': 'Week 104: Before dinner', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.58', 'spread': '1.97', 'groupId': 'OG000'}, {'value': '7.02', 'spread': '2.45', 'groupId': 'OG001'}]}]}, {'title': 'Week 104: 90 minutes after dinner', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.20', 'spread': '2.20', 'groupId': 'OG000'}, {'value': '9.10', 'spread': '2.61', 'groupId': 'OG001'}]}]}, {'title': 'Week 104: Bedtime', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.47', 'spread': '2.17', 'groupId': 'OG000'}, {'value': '7.90', 'spread': '2.41', 'groupId': 'OG001'}]}]}, {'title': 'Week 104: At 4:00 a.m.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.67', 'spread': '1.35', 'groupId': 'OG000'}, {'value': '5.96', 'spread': '1.73', 'groupId': 'OG001'}]}]}, {'title': 'Week 104: Before breakfast the following day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.44', 'spread': '1.23', 'groupId': 'OG000'}, {'value': '5.47', 'spread': '1.35', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 26, week 104', '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. Self-measured plasma glucose (SMPG)-9-point profile (individual points in the profile) at week 26 and week 104 is presented.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Number analyzed'=participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in SMPG-mean 9-point Profile', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '422', 'groupId': 'OG000'}, {'value': '389', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.34', 'spread': '2.46', 'groupId': 'OG000'}, {'value': '-3.32', 'spread': '2.62', 'groupId': 'OG001'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.27', 'spread': '2.36', 'groupId': 'OG000'}, {'value': '-2.76', 'spread': '2.41', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26, week 104', '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 9-point profile from baseline (week 0) to week 26 and week 104 is presented.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Number analyzed'=participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in SMPG-mean Postprandial Increment Over All Meals', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '405', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.28', 'spread': '2.13', 'groupId': 'OG000'}, {'value': '0.20', 'spread': '2.17', 'groupId': 'OG001'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.47', 'spread': '1.99', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '2.17', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26, week 104', '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 and week 104 is presented.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Number analyzed'=participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Blood Pressure (Systolic and Diastolic)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.'}], 'classes': [{'title': 'Week 26: Systolic blood pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '482', 'groupId': 'OG000'}, {'value': '466', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'spread': '14.0', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '13.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: Diastolic blood pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '482', 'groupId': 'OG000'}, {'value': '466', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '8.8', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '8.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 104: Systolic blood pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '14.3', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '13.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 104: Diastolic blood pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '8.8', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '8.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26, week 104', 'description': 'Change in blood pressure (systolic and diastolic) from baseline (week 0) to week 26 and week 104 is presented.', 'unitOfMeasure': 'Millimeters of mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Number analyzed'=participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Fasting C-peptide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '474', 'groupId': 'OG000'}, {'value': '458', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.63', 'spread': '60.79', 'groupId': 'OG000'}, {'value': '0.57', 'spread': '62.44', 'groupId': 'OG001'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '333', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.58', 'spread': '64.21', 'groupId': 'OG000'}, {'value': '0.54', 'spread': '70.45', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 0, week 26, week 104', 'description': 'Change in fasting C-peptide (measured in nanomoles per liter \\[nmol/L\\]) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.', 'unitOfMeasure': 'Ratio of C-peptide', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Number analyzed'=participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Fasting Human Insulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '478', 'groupId': 'OG000'}, {'value': '456', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.67', 'spread': '90.68', 'groupId': 'OG000'}, {'value': '0.68', 'spread': '89.19', 'groupId': 'OG001'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.60', 'spread': '91.84', 'groupId': 'OG000'}, {'value': '0.62', 'spread': '92.55', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 0, week 26, week 104', 'description': 'Change in fasting human insulin (measured in picomoles per liter \\[pmol/L\\]) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.', 'unitOfMeasure': 'Ratio of insulin', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Number analyzed'=participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Fasting Total Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '470', 'groupId': 'OG000'}, {'value': '455', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.99', 'spread': '17.38', 'groupId': 'OG000'}, {'value': '0.99', 'spread': '17.68', 'groupId': 'OG001'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '319', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.97', 'spread': '19.11', 'groupId': 'OG000'}, {'value': '0.97', 'spread': '20.40', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 0, week 26, week 104', 'description': 'Change in fasting total cholesterol (measured in mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.', 'unitOfMeasure': 'Ratio of total cholesterol', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Number analyzed'=participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Fasting LDL-cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '467', 'groupId': 'OG000'}, {'value': '452', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.05', 'spread': '35.97', 'groupId': 'OG000'}, {'value': '1.02', 'spread': '30.10', 'groupId': 'OG001'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.96', 'spread': '38.83', 'groupId': 'OG000'}, {'value': '0.98', 'spread': '34.40', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 0, week 26, week 104', 'description': 'Change in fasting low density lipoprotein (LDL)-cholesterol (measured in mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.', 'unitOfMeasure': 'Ratio of LDL-cholesterol', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Number analyzed'=participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Fasting HDL-cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '467', 'groupId': 'OG000'}, {'value': '454', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.03', 'spread': '16.61', 'groupId': 'OG000'}, {'value': '1.02', 'spread': '15.57', 'groupId': 'OG001'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '319', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.02', 'spread': '16.93', 'groupId': 'OG000'}, {'value': '1.03', 'spread': '17.36', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 0, week 26, week 104', 'description': 'Change in fasting high density lipoprotein (HDL)- cholesterol (measured in mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.', 'unitOfMeasure': 'Ratio of HDL-cholesterol', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Number analyzed'=participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Fasting VLDL-cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '468', 'groupId': 'OG000'}, {'value': '453', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.85', 'spread': '40.78', 'groupId': 'OG000'}, {'value': '0.85', 'spread': '42.01', 'groupId': 'OG001'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.90', 'spread': '40.90', 'groupId': 'OG000'}, {'value': '0.88', 'spread': '35.98', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 0, week 26, week 104', 'description': 'Change in fasting very low density lipoprotein (VLDL)-cholesterol (measured in mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.', 'unitOfMeasure': 'Ratio of VLDL-cholesterol', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Number analyzed'=participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Fasting Triglycerides', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '469', 'groupId': 'OG000'}, {'value': '455', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.84', 'spread': '43.82', 'groupId': 'OG000'}, {'value': '0.85', 'spread': '45.75', 'groupId': 'OG001'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '319', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.89', 'spread': '42.20', 'groupId': 'OG000'}, {'value': '0.89', 'spread': '40.08', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 0, week 26, week 104', 'description': 'Change in fasting triglycerides (measured as mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.', 'unitOfMeasure': 'Ratio of triglycerides', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Number analyzed'=participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Fasting Free Fatty Acids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '474', 'groupId': 'OG000'}, {'value': '460', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.68', 'spread': '59.69', 'groupId': 'OG000'}, {'value': '0.75', 'spread': '60.25', 'groupId': 'OG001'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '332', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.70', 'spread': '57.71', 'groupId': 'OG000'}, {'value': '0.78', 'spread': '59.48', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 0, week 26, week 104', 'description': 'Change in fasting free fatty acids (measured as mmol/L) from baseline (week 0) to week 26 and week 104 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. 'Number analyzed'=participants with available data."}, {'type': 'SECONDARY', 'title': 'Number of Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '504', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.'}], 'classes': [{'categories': [{'measurements': [{'value': '143', 'groupId': 'OG000'}, {'value': '261', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0-26', 'description': 'Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value \\<3.1 mmol/L (56 mg/dL) 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 during 26 weeks of treatment is presented.', 'unitOfMeasure': 'Episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants receiving at least 1 dose of the investigational product or comparator.'}, {'type': 'SECONDARY', 'title': 'Number of Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 104 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '504', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.'}], 'classes': [{'categories': [{'measurements': [{'value': '319', 'groupId': 'OG000'}, {'value': '642', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0-104', 'description': 'Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value \\<3.1 mmol/L (56 mg/dL) 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 during 104 weeks of treatment is presented.', 'unitOfMeasure': 'Episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants receiving at least 1 dose of the investigational product or comparator.'}, {'type': 'SECONDARY', 'title': 'Number of Treatment Emergent Hypoglycaemic Episodes During 26 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '504', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.'}], 'classes': [{'categories': [{'measurements': [{'value': '3190', 'groupId': 'OG000'}, {'value': '3806', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0-26', 'description': 'Hypoglycaemic episodes (SMPG value ≤3.9 mmol/L (70 mg/dL)) 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. 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 during 26 weeks of treatment is presented.', 'unitOfMeasure': 'Episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants receiving at least 1 dose of the investigational product or comparator.'}, {'type': 'SECONDARY', 'title': 'Number of Treatment Emergent Hypoglycaemic Episodes During 104 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '504', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.'}], 'classes': [{'categories': [{'measurements': [{'value': '8934', 'groupId': 'OG000'}, {'value': '10658', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0-104', 'description': 'Hypoglycaemic episodes (SMPG value ≤3.9 mmol/L (70 mg/dL)) 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. 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 during 104 weeks of treatment is presented.', 'unitOfMeasure': 'Episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants receiving at least 1 dose of the investigational product or comparator.'}, {'type': 'SECONDARY', 'title': 'Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '504', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0-26', 'description': 'Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value \\<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Nocturnal hypoglycaemic episodes were episodes occurring between 00:01 and 05.59 both inclusive. 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 nocturnal severe or BG confirmed symptomatic hypoglycaemic episodes during 26 weeks of treatment is presented.', 'unitOfMeasure': 'Episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants receiving at least 1 dose of the investigational product or comparator.'}, {'type': 'SECONDARY', 'title': 'Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 104 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '504', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.'}], 'classes': [{'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0-104', 'description': 'Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value \\<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Nocturnal hypoglycaemic episodes were episodes occurring between 00:01 and 05.59 both inclusive. 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 nocturnal severe or BG confirmed symptomatic hypoglycaemic episodes during 104 weeks of treatment is presented.', 'unitOfMeasure': 'Episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants receiving at least 1 dose of the investigational product or comparator.'}, {'type': 'SECONDARY', 'title': 'Number of TEAEs During 26 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '504', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.'}], 'classes': [{'categories': [{'measurements': [{'value': '718', 'groupId': 'OG000'}, {'value': '624', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0-26', 'description': 'An adverse event is any untoward medical occurrence in a participant administered a product, and which does not necessarily have a causal relationship with this treatment. A treatment emergent adverse event (TEAE) was defined as an adverse 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. If the event had onset date before the first day of exposure on trial product and increased in severity during the treatment period and until 7 days after the last drug date, then this event was also considered as a TEAE. Number of TEAEs during 26 weeks of treatment is presented.', 'unitOfMeasure': 'Adverse events', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants receiving at least 1 dose of the investigational product or comparator.'}, {'type': 'SECONDARY', 'title': 'Number of TEAEs During 104 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '504', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.'}], 'classes': [{'categories': [{'measurements': [{'value': '1788', 'groupId': 'OG000'}, {'value': '1368', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to week 104', 'description': 'An adverse event is any untoward medical occurrence in a participant administered a product, and which does not necessarily have a causal relationship with this treatment. A TEAE was defined as an adverse 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. If the event had onset date before the first day of exposure on trial product and increased in severity during the treatment period and until 7 days after the last drug date, then this event was also considered as a TEAE. Number of TEAEs during 104 weeks of treatment is presented.', 'unitOfMeasure': 'Adverse events', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants receiving at least 1 dose of the investigational product or comparator.'}, {'type': 'SECONDARY', 'title': 'Eye Examination Category', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '504', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.'}], 'classes': [{'title': 'Left eye: Normal (baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '504', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '345', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}]}]}, {'title': 'Left eye: Abnormal NCS (baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '504', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '151', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}]}, {'title': 'Left eye: Abnormal CS (baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '504', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Left eye: Normal (week 104)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '204', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}]}, {'title': 'Left eye: Abnormal NCS (week 104)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}, {'title': 'Left eye: Abnormal CS (week 104)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Right eye: Normal (baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '504', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '344', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}]}, {'title': 'Right eye: Abnormal NCS (baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '504', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '151', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}]}, {'title': 'Right eye: Abnormal CS (baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '504', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Right eye: Normal (week 104)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '200', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}]}, {'title': 'Right eye: Abnormal NCS (week 104)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'Right eye: Abnormal CS (week 104)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (within 12 weeks prior to week 0), week 104', 'description': "Fundus photography or a dilated fundoscopy was performed at baseline (within 12 weeks prior to week 0) and week 104. The investigator interpreted each eye's (left and right) results and categorised them as: normal, abnormal not clinically significant (NCS) or abnormal clinically significant (CS). Number of participants in each category at baseline and week 104 were presented.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "SAS included all participants receiving at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data."}, {'type': 'SECONDARY', 'title': 'ECG Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '504', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.'}], 'classes': [{'title': 'Normal (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '504', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '335', 'groupId': 'OG000'}, {'value': '335', 'groupId': 'OG001'}]}]}, {'title': 'Abnormal NCS (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '504', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '162', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}]}]}, {'title': 'Abnormal CS (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '504', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Normal (week 104)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '227', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}]}, {'title': 'Abnormal NCS (week 104)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}]}, {'title': 'Abnormal CS (week 104)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (within 2 weeks prior to week 0), week 104', 'description': 'The electrocardiogram (ECG) was assessed at baseline (within 2 weeks prior to week 0) and week 104. The investigator interpreted the results and categorised them as: normal, abnormal NCS or abnormal CS. Number of participants in each ECG category at baseline and week 104 are presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "SAS included all participants receiving at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Urine Albumin/Creatinine Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '504', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.09', 'spread': '7.43', 'groupId': 'OG000'}, {'value': '-0.74', 'spread': '15.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 104', 'description': 'Change in urine albumin/creatinine ratio from baseline (week 0) to week 104 is presented.', 'unitOfMeasure': 'Milligrams per millimole (mg/mmol)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "SAS included all participants receiving at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Pulse Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '504', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '482', 'groupId': 'OG000'}, {'value': '466', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '8.8', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '8.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '9.3', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '9.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26, week 104', 'description': 'Change in pulse rate from baseline (week 0) to week 26 and week 104 is presented.', 'unitOfMeasure': 'Beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Biochemistry Parameter- Creatinine, Total Bilirubin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '504', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.'}], 'classes': [{'title': 'Week 26: creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '476', 'groupId': 'OG000'}, {'value': '462', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.50', 'spread': '10.08', 'groupId': 'OG000'}, {'value': '0.25', 'spread': '8.78', 'groupId': 'OG001'}]}]}, {'title': 'Week 104: creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '325', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.75', 'spread': '10.85', 'groupId': 'OG000'}, {'value': '2.20', 'spread': '11.86', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: total bilirubin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '476', 'groupId': 'OG000'}, {'value': '462', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.30', 'spread': '3.35', 'groupId': 'OG000'}, {'value': '-0.32', 'spread': '2.80', 'groupId': 'OG001'}]}]}, {'title': 'Week 104: total bilirubin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '324', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.33', 'spread': '3.42', 'groupId': 'OG000'}, {'value': '-0.59', 'spread': '3.01', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26, week 104', 'description': 'Change in biochemistry parameter- creatinine, total bilirubin from baseline (week 0) to week 26 and week 104 is presented.', 'unitOfMeasure': 'Micromoles per liter (umol/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Biochemistry Parameter- Albumin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '504', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '477', 'groupId': 'OG000'}, {'value': '462', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.21', 'groupId': 'OG001'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '324', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.27', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26, week 104', 'description': 'Change in biochemistry parameter- albumin from baseline (week 0) to week 26 and week 104 is presented.', 'unitOfMeasure': 'Grams per deciliter (g/dL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Biochemistry Parameters- ALP, ALT, AST, Lipase and Amylase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '504', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.'}], 'classes': [{'title': 'Week 26: ALP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '476', 'groupId': 'OG000'}, {'value': '462', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.16', 'spread': '14.16', 'groupId': 'OG000'}, {'value': '-4.33', 'spread': '12.84', 'groupId': 'OG001'}]}]}, {'title': 'Week 104: ALP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '324', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.35', 'spread': '15.71', 'groupId': 'OG000'}, {'value': '-1.34', 'spread': '14.22', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: ALT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '476', 'groupId': 'OG000'}, {'value': '462', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.45', 'spread': '18.50', 'groupId': 'OG000'}, {'value': '-3.33', 'spread': '13.24', 'groupId': 'OG001'}]}]}, {'title': 'Week 104: ALT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.39', 'spread': '14.16', 'groupId': 'OG000'}, {'value': '-3.45', 'spread': '14.46', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: AST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '476', 'groupId': 'OG000'}, {'value': '462', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.62', 'spread': '9.78', 'groupId': 'OG000'}, {'value': '-0.39', 'spread': '9.51', 'groupId': 'OG001'}]}]}, {'title': 'Week 104: AST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.84', 'spread': '9.86', 'groupId': 'OG000'}, {'value': '-0.67', 'spread': '10.78', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: lipase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '476', 'groupId': 'OG000'}, {'value': '462', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.26', 'spread': '42.92', 'groupId': 'OG000'}, {'value': '-7.97', 'spread': '34.28', 'groupId': 'OG001'}]}]}, {'title': 'Week 104: lipase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '325', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.41', 'spread': '48.35', 'groupId': 'OG000'}, {'value': '-13.33', 'spread': '42.27', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: amylase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '477', 'groupId': 'OG000'}, {'value': '462', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.72', 'spread': '23.28', 'groupId': 'OG000'}, {'value': '2.79', 'spread': '20.92', 'groupId': 'OG001'}]}]}, {'title': 'Week 104: amylase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '325', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.23', 'spread': '25.42', 'groupId': 'OG000'}, {'value': '-0.13', 'spread': '25.94', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26, week 104', 'description': 'Change in biochemistry parameters- alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), lipase and amylase from baseline (week 0) to week 26 and week 104 is presented.', 'unitOfMeasure': 'Units per liter (U/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Biochemistry Parameter- Sodium, Potassium and Calcium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '504', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.'}], 'classes': [{'title': 'Week 26: sodium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '477', 'groupId': 'OG000'}, {'value': '462', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.89', 'spread': '2.74', 'groupId': 'OG000'}, {'value': '1.03', 'spread': '2.61', 'groupId': 'OG001'}]}]}, {'title': 'Week 104: sodium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '325', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.22', 'spread': '2.54', 'groupId': 'OG000'}, {'value': '1.47', 'spread': '2.39', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: potassium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '477', 'groupId': 'OG000'}, {'value': '461', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.05', 'spread': '0.40', 'groupId': 'OG000'}, {'value': '-0.08', 'spread': '0.42', 'groupId': 'OG001'}]}]}, {'title': 'Week 104: potassium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '324', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.42', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '0.43', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: calcium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '475', 'groupId': 'OG000'}, {'value': '462', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '-0.00', 'spread': '0.11', 'groupId': 'OG001'}]}]}, {'title': 'Week 104: calcium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.07', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '0.11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26, week 104', 'description': 'Change in sodium, potassium and calcium from baseline (week 0) to week 26 and week 104 is presented.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Haematological Parameter- Haemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '504', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '463', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.08', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '0.74', 'groupId': 'OG001'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.00', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.92', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26, week 104', 'description': 'Change in haemoglobin from baseline (week 0) to week 26 and week 104 is presented.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Haematological Parameter- Haematocrit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '504', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '478', 'groupId': 'OG000'}, {'value': '462', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.33', 'spread': '2.45', 'groupId': 'OG000'}, {'value': '-0.36', 'spread': '2.43', 'groupId': 'OG001'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.71', 'spread': '2.83', 'groupId': 'OG000'}, {'value': '-0.95', 'spread': '3.02', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26, week 104', 'description': 'Change in haematocrit from baseline (week 0) to week 26 and week 104 is presented.', 'unitOfMeasure': 'Percentage of red blood cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Haematological Parameter- Erythrocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '504', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '464', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.27', 'groupId': 'OG001'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.12', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '-0.11', 'spread': '0.32', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26, week 104', 'description': 'Change in erythrocytes from baseline (week 0) to week 26 and week 104 is presented.', 'unitOfMeasure': '10^12 cells/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Haematological Parameter- Thrombocytes and Leukocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '504', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.'}], 'classes': [{'title': 'Week 26: Thrombocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '476', 'groupId': 'OG000'}, {'value': '463', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.77', 'spread': '35.82', 'groupId': 'OG000'}, {'value': '7.05', 'spread': '41.71', 'groupId': 'OG001'}]}]}, {'title': 'Week 104: Thrombocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.87', 'spread': '39.27', 'groupId': 'OG000'}, {'value': '18.73', 'spread': '53.76', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: Leukocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '464', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.49', 'spread': '1.45', 'groupId': 'OG000'}, {'value': '0.39', 'spread': '1.43', 'groupId': 'OG001'}]}]}, {'title': 'Week 104: Leukocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.07', 'spread': '1.50', 'groupId': 'OG000'}, {'value': '0.32', 'spread': '1.55', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26, week 104', 'description': 'Change in thrombocytes and leukocytes from baseline (week 0) to week 26 and week 104 is presented.', 'unitOfMeasure': '10^9 cells/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Haematological Parameter- Eosinophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '504', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '478', 'groupId': 'OG000'}, {'value': '464', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.10', 'spread': '1.88', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '2.09', 'groupId': 'OG001'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.32', 'spread': '2.08', 'groupId': 'OG000'}, {'value': '0.43', 'spread': '1.56', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26, week 104', 'description': 'Change in eosinophils from baseline (week 0) to week 26 and week 104 is presented.', 'unitOfMeasure': 'Percentage of eosinophils', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Haematological Parameter- Neutrophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '504', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '478', 'groupId': 'OG000'}, {'value': '464', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.86', 'spread': '7.20', 'groupId': 'OG000'}, {'value': '0.78', 'spread': '7.68', 'groupId': 'OG001'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.25', 'spread': '7.94', 'groupId': 'OG000'}, {'value': '1.21', 'spread': '8.02', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26, week 104', 'description': 'Change in neutrophils from baseline (week 0) to week 26 and week 104 is presented.', 'unitOfMeasure': 'Percentage of neutrophils', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Haematological Parameter- Basophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '504', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '478', 'groupId': 'OG000'}, {'value': '464', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '-0.00', 'spread': '0.29', 'groupId': 'OG001'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.20', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '0.16', 'spread': '0.35', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26, week 104', 'description': 'Change in basophils from baseline (week 0) to week 26 and week 104 is presented.', 'unitOfMeasure': 'Percentage of basophils', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Haematological Parameter- Monocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '504', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '478', 'groupId': 'OG000'}, {'value': '464', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.10', 'spread': '2.04', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '1.91', 'groupId': 'OG001'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.49', 'spread': '2.02', 'groupId': 'OG000'}, {'value': '0.59', 'spread': '1.88', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26, week 104', 'description': 'Change in monocytes from baseline (week 0) to week 26 and week 104 is presented.', 'unitOfMeasure': 'Percentage of monocytes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Haematological Parameter- Lymphocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '504', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '478', 'groupId': 'OG000'}, {'value': '464', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.87', 'spread': '6.29', 'groupId': 'OG000'}, {'value': '-0.84', 'spread': '6.73', 'groupId': 'OG001'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.25', 'spread': '6.76', 'groupId': 'OG000'}, {'value': '-2.38', 'spread': '7.29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26, week 104', 'description': 'Change in lymphocytes from baseline (week 0) to week 26 and week 104 is presented.', 'unitOfMeasure': 'Percentage of lymphocytes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Calcitonin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '504', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.'}], 'classes': [{'title': 'Week 0: Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '504', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 0: Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '504', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '481', 'groupId': 'OG000'}, {'value': '472', 'groupId': 'OG001'}]}]}, {'title': 'Week 0: High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '504', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '477', 'groupId': 'OG000'}, {'value': '461', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '477', 'groupId': 'OG000'}, {'value': '461', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '437', 'groupId': 'OG000'}, {'value': '431', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '477', 'groupId': 'OG000'}, {'value': '461', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Week 104: Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '332', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 104: Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '332', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '301', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}]}, {'title': 'Week 104: High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '332', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 0, week 26, week 104', 'description': 'The number of participants who reported low, normal and high levels of calcitonin in relation to reference ranges at baseline (week 0), week 26 and week 104 are presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.'}], 'classes': [{'title': 'Week 26: Physical functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '482', 'groupId': 'OG000'}, {'value': '465', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.2', 'spread': '6.8', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '7.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 104: Physical functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '7.5', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '7.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: Role-physical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '482', 'groupId': 'OG000'}, {'value': '465', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '7.7', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '7.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 104: Role-physical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '8.7', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '7.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: Bodily pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '482', 'groupId': 'OG000'}, {'value': '465', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '9.7', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '10.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 104: Bodily pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': '11.2', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '8.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: General health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '482', 'groupId': 'OG000'}, {'value': '465', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.5', 'spread': '8.2', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '7.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 104: General health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.3', 'spread': '8.7', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '8.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: Vitality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '482', 'groupId': 'OG000'}, {'value': '465', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '8.1', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '8.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 104: Vitality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '8.4', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '8.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: Social functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '482', 'groupId': 'OG000'}, {'value': '465', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.8', 'spread': '8.1', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '8.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 104: Social functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '8.9', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '7.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: Role-emotional', 'denoms': [{'units': 'Participants', 'counts': [{'value': '482', 'groupId': 'OG000'}, {'value': '465', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '8.9', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '8.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 104: Role-emotional', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': '10.1', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '8.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: Mental health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '482', 'groupId': 'OG000'}, {'value': '465', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '8.7', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '8.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 104: Mental health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.5', 'spread': '9.4', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '8.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: PCS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '482', 'groupId': 'OG000'}, {'value': '465', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': '6.3', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '6.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 104: PCS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '7.2', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '6.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: MCS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '482', 'groupId': 'OG000'}, {'value': '465', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '8.2', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '8.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 104: MCS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '9.0', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '7.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26, week 104', 'description': "SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline in the sub-domain scores and component summary (PCS and MCS) scores are presented. A positive change score indicates an improvement since baseline.", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Number analyzed'=participants with available data."}, {'type': 'SECONDARY', 'title': 'Change in TRIM-D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '477', 'groupId': 'OG000'}, {'value': '456', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.6', 'spread': '12.4', 'groupId': 'OG000'}, {'value': '7.3', 'spread': '13.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '332', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.4', 'spread': '13.7', 'groupId': 'OG000'}, {'value': '9.5', 'spread': '12.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26, week 104', 'description': 'Treatment related impact measures-diabetes (TRIM-D) was developed according to the FDA guidance from 2009 on development of new PRO measures. The questionnaire consists of 5 sub-domains, which are scored according to a 1-5 point scale with a higher score indicating a better health state (less negative impact). Sub-domain scores are calculated by summing across items in the same sub-domain, and the total score is calculated by summing scores from all the sub-domains. The highest possible summed score within a sub-domain ranges from 20 (compliance sub-domain) to 40 (psychological health sub-domain) points and the highest possible total score is 140 points. Change in TRIM-D total score from baseline (week 0) to week 26 and week 104 is presented. A positive change score indicates an improvement since baseline.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. 'Number analyzed'=participants with available data."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received subcutaneous (s.c.) injection of Insulin degludec/liraglutide (IDegLira) once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 milligrams \\[mg\\] liraglutide) initially. The dose was then escalated twice weekly until the fasting plasma glucose (FPG) target between 4.0-5.0 millimoles per liter (mmol/L) (72-90 milligrams per deciliter \\[mg/dL\\]) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).'}, {'id': 'FG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '506'}, {'groupId': 'FG001', 'numSubjects': '506'}]}, {'type': 'Exposed', 'achievements': [{'groupId': 'FG000', 'numSubjects': '506'}, {'groupId': 'FG001', 'numSubjects': '504'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '484'}, {'groupId': 'FG001', 'numSubjects': '481'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '25'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The trial was conducted at 130 sites in Argentina (4),Czech Republic (4), Hungary (5), India (11), Israel (8), Italy (7), Mexico (4), Norway (7), Poland (3), Russian Federation (8), Slovakia (5), South Africa (10), Turkey (8), United Kingdom (9) and United States (37).', 'preAssignmentDetails': 'Participants were randomised in a 1:1 manner to receive either IDegLira or IGlar as an adjunct to oral anti-diabetic drugs (OADs). OADs allowed were: biguanides, sulphonylurea (SU), glinides, pioglitazone, and dipeptidyl peptidase-4 inhibitors (DPP4-inhibitors), though glinides and DPP4-inhibitors were not allowed as monotherapy or in combination.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'BG000'}, {'value': '506', 'groupId': 'BG001'}, {'value': '1012', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).'}, {'id': 'BG001', 'title': 'Insulin Glargine', 'description': 'Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.8', 'spread': '10.0', 'groupId': 'BG000'}, {'value': '56.4', 'spread': '10.1', 'groupId': 'BG001'}, {'value': '56.6', 'spread': '10.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '226', 'groupId': 'BG000'}, {'value': '231', 'groupId': 'BG001'}, {'value': '457', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '280', 'groupId': 'BG000'}, {'value': '275', 'groupId': 'BG001'}, {'value': '555', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '115', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '241', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '391', 'groupId': 'BG000'}, {'value': '380', 'groupId': 'BG001'}, {'value': '771', '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/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '424', 'groupId': 'BG000'}, {'value': '414', 'groupId': 'BG001'}, {'value': '838', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full analysis set (FAS) included all randomised participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-03-01', 'size': 2148229, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-10-03T08:43', 'hasProtocol': True}, {'date': '2019-03-07', 'size': 6182827, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-10-03T08:56', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1012}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2018-10-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-08', 'studyFirstSubmitDate': '2015-07-15', 'resultsFirstSubmitDate': '2019-10-03', 'studyFirstSubmitQcDate': '2015-07-15', 'lastUpdatePostDateStruct': {'date': '2019-11-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-08', 'studyFirstPostDateStruct': {'date': '2015-07-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time From Randomisation to Inadequate Glycaemic Control and Need for Treatment Intensification', 'timeFrame': 'Weeks 0-104 + 7 days follow-up-1 + 30 days follow-up-2', 'description': 'Inadequate glycaemic control and need for treatment intensification was defined as a glycosylated haemoglobin (HbA1c) of 7.0% or greater at 2 consecutive visits from week 26, including week 26 if HbA1c was greater than or equal to 7% at week 12. Time from randomisation to inadequate glycaemic control and need for treatment intensification was analysed using a stratified log-rank test where treatment, baseline HbA1c group and previous OAD treatment were included as strata in the model. The variable "baseline HbA1c group" was a dichotomised baseline HbA1c variable with 2 categories: HbA1c \\< 8.5% or HbA1c ≥ 8.5% and the variable "previous OAD treatment" was a categorical variable with 2 categories: SU ± OAD(s) (SU users) or OAD(s) (Non-SU users). 25%, median (50%) and 75% percentiles for the cumulative distribution function were obtained from the Kaplan-Meier survival function.'}], 'secondaryOutcomes': [{'measure': 'Time From Randomisation to HbA1c >6.5% at 2 Consecutive Visits', 'timeFrame': 'Weeks 0-104 + 7 days follow-up-1 + 30 days follow-up-2', 'description': 'Time to HbA1c \\> 6.5% at 2 consecutive visits is defined as time from randomization to HbA1c \\> 6.5% at 2 consecutive planned scheduled visits from week 26 (including week 26 if HbA1c was \\> 6.5% at week 12). Time from randomisation to HbA1c \\>6.5% at 2 consecutive visits was analysed using a stratified log-rank test where treatment, baseline HbA1c group and previous OAD treatment were included as strata in the model. The variable "baseline HbA1c group" was a dichotomised baseline HbA1c variable with 2 categories: HbA1c \\< 8.5% or HbA1c ≥ 8.5% and the variable "previous OAD treatment" was a categorical variable with 2 categories: SU ± OAD(s) (SU users) or OAD(s) (Non-SU users). 25%, median (50%) and 75% percentiles for the cumulative distribution function were obtained from the Kaplan-Meier survival function.'}, {'measure': 'Change in HbA1c', 'timeFrame': 'Week 0, week 26', 'description': 'Change in HbA1c from baseline (week 0) to week 26 is presented.'}, {'measure': 'Change in Body Weight', 'timeFrame': 'Week 0, week 26, week 104', 'description': 'Change in body weight from baseline (week 0) to week 26 and week 104 is presented.'}, {'measure': 'Insulin Dose', 'timeFrame': 'Week 26, week 104', 'description': 'Insulin dose after 26 and 104 weeks of treatment is presented.'}, {'measure': 'Participants Who Achieved (Yes/no): HbA1c <7.0%', 'timeFrame': 'Week 26, week 104', 'description': 'Percentage of participants who achieved (yes/no) HbA1c \\<7.0% at week 26 and week 104 is presented.'}, {'measure': 'Participants Who Achieved (Yes/no): HbA1c <7.0% Without Weight Gain', 'timeFrame': 'Week 26, week 104', 'description': 'Percentage of participants who achieved (yes/no) HbA1c \\<7.0% without weight gain at week 26 and week 104 is presented.'}, {'measure': 'Participants Who Achieved (Yes/no): HbA1c <7.0% Without Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes', 'timeFrame': 'Week 26, week 104', 'description': 'Severe or BG confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the American Diabetes Association (ADA) classification or BG confirmed by a plasma glucose value \\<3.1 mmol/L (56 mg/dL) 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. Percentage of participants who achieved (yes/no) HbA1c \\<7.0% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes at week 26 and week 104 is presented.'}, {'measure': 'Participants Who Achieved (Yes/no): HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain', 'timeFrame': 'Week 26, week 104', 'description': 'Severe or BG confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the ADA classification or BG confirmed by a plasma glucose value \\<3.1 mmol/L (56 mg/dL) 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. Percentage of participants who achieved (yes/no) HbA1c \\<7.0% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes and without weight gain at week 26 and week 104 is presented.'}, {'measure': 'Participants Who Achieved (Yes/no): HbA1c ≤6.5%', 'timeFrame': 'Week 26, week 104', 'description': 'Percentage of participants who achieved (yes/no) HbA1c ≤6.5% at week 26 and week 104 is presented.'}, {'measure': 'Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Weight Gain', 'timeFrame': 'Week 26, week 104', 'description': 'Percentage of participants who achieved (yes/no) HbA1c ≤6.5% without weight gain at week 26 and week 104 is presented.'}, {'measure': 'Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes', 'timeFrame': 'Week 26, week 104', 'description': 'Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value \\<3.1 mmol/L (56 mg/dL) 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. Percentage of participants who achieved (yes/no) HbA1c ≤6.5% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes at week 26 and week 104 is presented.'}, {'measure': 'Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain', 'timeFrame': 'Week 26, week 104', 'description': 'Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value \\<3.1 mmol/L (56 mg/dL) 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. Percentage of participants who achieved (yes/no) HbA1c ≤6.5% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes and without weight gain at week 26 and week 104 is presented.'}, {'measure': 'Change in FPG', 'timeFrame': 'Week 0, week 26, week 104', 'description': 'Change in fasting plasma glucose (FPG) from baseline (week 0) to week 26 and week 104 is presented.'}, {'measure': 'SMPG-9-point Profile (Individual Points in the Profile)', 'timeFrame': 'Week 26, week 104', '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. Self-measured plasma glucose (SMPG)-9-point profile (individual points in the profile) at week 26 and week 104 is presented.'}, {'measure': 'Change in SMPG-mean 9-point Profile', 'timeFrame': 'Week 0, week 26, week 104', '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 9-point profile from baseline (week 0) to week 26 and week 104 is presented.'}, {'measure': 'Change in SMPG-mean Postprandial Increment Over All Meals', 'timeFrame': 'Week 0, week 26, week 104', '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 and week 104 is presented.'}, {'measure': 'Change in Blood Pressure (Systolic and Diastolic)', 'timeFrame': 'Week 0, week 26, week 104', 'description': 'Change in blood pressure (systolic and diastolic) from baseline (week 0) to week 26 and week 104 is presented.'}, {'measure': 'Change in Fasting C-peptide', 'timeFrame': 'Week 0, week 26, week 104', 'description': 'Change in fasting C-peptide (measured in nanomoles per liter \\[nmol/L\\]) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.'}, {'measure': 'Change in Fasting Human Insulin', 'timeFrame': 'Week 0, week 26, week 104', 'description': 'Change in fasting human insulin (measured in picomoles per liter \\[pmol/L\\]) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.'}, {'measure': 'Change in Fasting Total Cholesterol', 'timeFrame': 'Week 0, week 26, week 104', 'description': 'Change in fasting total cholesterol (measured in mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.'}, {'measure': 'Change in Fasting LDL-cholesterol', 'timeFrame': 'Week 0, week 26, week 104', 'description': 'Change in fasting low density lipoprotein (LDL)-cholesterol (measured in mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.'}, {'measure': 'Change in Fasting HDL-cholesterol', 'timeFrame': 'Week 0, week 26, week 104', 'description': 'Change in fasting high density lipoprotein (HDL)- cholesterol (measured in mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.'}, {'measure': 'Change in Fasting VLDL-cholesterol', 'timeFrame': 'Week 0, week 26, week 104', 'description': 'Change in fasting very low density lipoprotein (VLDL)-cholesterol (measured in mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.'}, {'measure': 'Change in Fasting Triglycerides', 'timeFrame': 'Week 0, week 26, week 104', 'description': 'Change in fasting triglycerides (measured as mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.'}, {'measure': 'Change in Fasting Free Fatty Acids', 'timeFrame': 'Week 0, week 26, week 104', 'description': 'Change in fasting free fatty acids (measured as mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.'}, {'measure': 'Number of Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks of Treatment', 'timeFrame': 'Weeks 0-26', 'description': 'Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value \\<3.1 mmol/L (56 mg/dL) 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 during 26 weeks of treatment is presented.'}, {'measure': 'Number of Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 104 Weeks of Treatment', 'timeFrame': 'Weeks 0-104', 'description': 'Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value \\<3.1 mmol/L (56 mg/dL) 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 during 104 weeks of treatment is presented.'}, {'measure': 'Number of Treatment Emergent Hypoglycaemic Episodes During 26 Weeks of Treatment', 'timeFrame': 'Weeks 0-26', 'description': 'Hypoglycaemic episodes (SMPG value ≤3.9 mmol/L (70 mg/dL)) 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. 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 during 26 weeks of treatment is presented.'}, {'measure': 'Number of Treatment Emergent Hypoglycaemic Episodes During 104 Weeks of Treatment', 'timeFrame': 'Weeks 0-104', 'description': 'Hypoglycaemic episodes (SMPG value ≤3.9 mmol/L (70 mg/dL)) 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. 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 during 104 weeks of treatment is presented.'}, {'measure': 'Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks of Treatment', 'timeFrame': 'Weeks 0-26', 'description': 'Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value \\<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Nocturnal hypoglycaemic episodes were episodes occurring between 00:01 and 05.59 both inclusive. 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 nocturnal severe or BG confirmed symptomatic hypoglycaemic episodes during 26 weeks of treatment is presented.'}, {'measure': 'Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 104 Weeks of Treatment', 'timeFrame': 'Weeks 0-104', 'description': 'Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value \\<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Nocturnal hypoglycaemic episodes were episodes occurring between 00:01 and 05.59 both inclusive. 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 nocturnal severe or BG confirmed symptomatic hypoglycaemic episodes during 104 weeks of treatment is presented.'}, {'measure': 'Number of TEAEs During 26 Weeks of Treatment', 'timeFrame': 'Weeks 0-26', 'description': 'An adverse event is any untoward medical occurrence in a participant administered a product, and which does not necessarily have a causal relationship with this treatment. A treatment emergent adverse event (TEAE) was defined as an adverse 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. If the event had onset date before the first day of exposure on trial product and increased in severity during the treatment period and until 7 days after the last drug date, then this event was also considered as a TEAE. Number of TEAEs during 26 weeks of treatment is presented.'}, {'measure': 'Number of TEAEs During 104 Weeks of Treatment', 'timeFrame': 'Week 0 to week 104', 'description': 'An adverse event is any untoward medical occurrence in a participant administered a product, and which does not necessarily have a causal relationship with this treatment. A TEAE was defined as an adverse 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. If the event had onset date before the first day of exposure on trial product and increased in severity during the treatment period and until 7 days after the last drug date, then this event was also considered as a TEAE. Number of TEAEs during 104 weeks of treatment is presented.'}, {'measure': 'Eye Examination Category', 'timeFrame': 'Baseline (within 12 weeks prior to week 0), week 104', 'description': "Fundus photography or a dilated fundoscopy was performed at baseline (within 12 weeks prior to week 0) and week 104. The investigator interpreted each eye's (left and right) results and categorised them as: normal, abnormal not clinically significant (NCS) or abnormal clinically significant (CS). Number of participants in each category at baseline and week 104 were presented."}, {'measure': 'ECG Evaluation', 'timeFrame': 'Baseline (within 2 weeks prior to week 0), week 104', 'description': 'The electrocardiogram (ECG) was assessed at baseline (within 2 weeks prior to week 0) and week 104. The investigator interpreted the results and categorised them as: normal, abnormal NCS or abnormal CS. Number of participants in each ECG category at baseline and week 104 are presented.'}, {'measure': 'Change in Urine Albumin/Creatinine Ratio', 'timeFrame': 'Week 0, week 104', 'description': 'Change in urine albumin/creatinine ratio from baseline (week 0) to week 104 is presented.'}, {'measure': 'Change in Pulse Rate', 'timeFrame': 'Week 0, week 26, week 104', 'description': 'Change in pulse rate from baseline (week 0) to week 26 and week 104 is presented.'}, {'measure': 'Change in Biochemistry Parameter- Creatinine, Total Bilirubin', 'timeFrame': 'Week 0, week 26, week 104', 'description': 'Change in biochemistry parameter- creatinine, total bilirubin from baseline (week 0) to week 26 and week 104 is presented.'}, {'measure': 'Change in Biochemistry Parameter- Albumin', 'timeFrame': 'Week 0, week 26, week 104', 'description': 'Change in biochemistry parameter- albumin from baseline (week 0) to week 26 and week 104 is presented.'}, {'measure': 'Change in Biochemistry Parameters- ALP, ALT, AST, Lipase and Amylase', 'timeFrame': 'Week 0, week 26, week 104', 'description': 'Change in biochemistry parameters- alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), lipase and amylase from baseline (week 0) to week 26 and week 104 is presented.'}, {'measure': 'Change in Biochemistry Parameter- Sodium, Potassium and Calcium', 'timeFrame': 'Week 0, week 26, week 104', 'description': 'Change in sodium, potassium and calcium from baseline (week 0) to week 26 and week 104 is presented.'}, {'measure': 'Change in Haematological Parameter- Haemoglobin', 'timeFrame': 'Week 0, week 26, week 104', 'description': 'Change in haemoglobin from baseline (week 0) to week 26 and week 104 is presented.'}, {'measure': 'Change in Haematological Parameter- Haematocrit', 'timeFrame': 'Week 0, week 26, week 104', 'description': 'Change in haematocrit from baseline (week 0) to week 26 and week 104 is presented.'}, {'measure': 'Change in Haematological Parameter- Erythrocytes', 'timeFrame': 'Week 0, week 26, week 104', 'description': 'Change in erythrocytes from baseline (week 0) to week 26 and week 104 is presented.'}, {'measure': 'Change in Haematological Parameter- Thrombocytes and Leukocytes', 'timeFrame': 'Week 0, week 26, week 104', 'description': 'Change in thrombocytes and leukocytes from baseline (week 0) to week 26 and week 104 is presented.'}, {'measure': 'Change in Haematological Parameter- Eosinophils', 'timeFrame': 'Week 0, week 26, week 104', 'description': 'Change in eosinophils from baseline (week 0) to week 26 and week 104 is presented.'}, {'measure': 'Change in Haematological Parameter- Neutrophils', 'timeFrame': 'Week 0, week 26, week 104', 'description': 'Change in neutrophils from baseline (week 0) to week 26 and week 104 is presented.'}, {'measure': 'Change in Haematological Parameter- Basophils', 'timeFrame': 'Week 0, week 26, week 104', 'description': 'Change in basophils from baseline (week 0) to week 26 and week 104 is presented.'}, {'measure': 'Change in Haematological Parameter- Monocytes', 'timeFrame': 'Week 0, week 26, week 104', 'description': 'Change in monocytes from baseline (week 0) to week 26 and week 104 is presented.'}, {'measure': 'Change in Haematological Parameter- Lymphocytes', 'timeFrame': 'Week 0, week 26, week 104', 'description': 'Change in lymphocytes from baseline (week 0) to week 26 and week 104 is presented.'}, {'measure': 'Change in Calcitonin', 'timeFrame': 'Week 0, week 26, week 104', 'description': 'The number of participants who reported low, normal and high levels of calcitonin in relation to reference ranges at baseline (week 0), week 26 and week 104 are presented.'}, {'measure': 'Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS)', 'timeFrame': 'Week 0, week 26, week 104', 'description': "SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline in the sub-domain scores and component summary (PCS and MCS) scores are presented. A positive change score indicates an improvement since baseline."}, {'measure': 'Change in TRIM-D', 'timeFrame': 'Week 0, week 26, week 104', 'description': 'Treatment related impact measures-diabetes (TRIM-D) was developed according to the FDA guidance from 2009 on development of new PRO measures. The questionnaire consists of 5 sub-domains, which are scored according to a 1-5 point scale with a higher score indicating a better health state (less negative impact). Sub-domain scores are calculated by summing across items in the same sub-domain, and the total score is calculated by summing scores from all the sub-domains. The highest possible summed score within a sub-domain ranges from 20 (compliance sub-domain) to 40 (psychological health sub-domain) points and the highest possible total score is 140 points. Change in TRIM-D total score from baseline (week 0) to week 26 and week 104 is presented. A positive change score indicates an improvement since baseline.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '31189519', 'type': 'RESULT', 'citation': 'Aroda VR, Gonzalez-Galvez G, Gron R, Halladin N, Haluzik M, Jermendy G, Kok A, Orsy P, Sabbah M, Sesti G, Silver R. Durability of insulin degludec plus liraglutide versus insulin glargine U100 as initial injectable therapy in type 2 diabetes (DUAL VIII): a multicentre, open-label, phase 3b, randomised controlled trial. Lancet Diabetes Endocrinol. 2019 Aug;7(8):596-605. doi: 10.1016/S2213-8587(19)30184-6. Epub 2019 Jun 9.'}, {'pmid': '36710452', 'type': 'DERIVED', 'citation': "Philis-Tsimikas A, Aroda VR, De Block C, Billings LK, Liebl A, Sivarathinasami R, D'Cruz JM, Lingvay I. Higher Derived Time in Range With IDegLira Versus Insulin Glargine U100 in People With Type 2 Diabetes. J Diabetes Sci Technol. 2024 May;18(3):653-659. doi: 10.1177/19322968221149041. Epub 2023 Jan 29."}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Africa, Asia, Europe, North America and South America. The purpose is to compare long-term glycaemic control of insulin degludec/liraglutide (IDegLira) versus insulin glargine (IGlar) in insulin naïve subjects with type 2 diabetes mellitus inadequately controlled with oral anti diabetics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, age greater than or equal to 18 years at the time of signing informed consent\n* Subjects diagnosed with type 2 diabetes mellitus\n* HbA1c 7.0-11.0% (both inclusive) (53-97 mmol/mol) by central laboratory analysis\n* Body mass index greater than or equal to 20 kg/m\\^2\n* Insulin naïve subjects; however short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes\n* Stable daily dose(s) including any of the following antidiabetic drug(s)/regimens within 90 days prior to the day of screening: a) Biguanides (metformin greater than or equal to 1500 mg or maximum tolerated dose documented in the subject medical record), b) Other OAD(s) allowed: sulphonylurea, glinides, pioglitazone, and DPP4-inhibitors (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated dose as documented in subjects medical record)\n\nExclusion Criteria:\n\n* Screening calcitonin greater than or equal to 50 ng/L\n* Renal impairment estimated Glomerular Filtration Rate (eGFR) less than 60 ml/min/1.73 m2 as per CKD-EPI value to be defined as listed in the classification CKD-EPI using IDMS for serum creatinine measurement on the day of screening\n* Impaired liver function, defined as ALAT or ASAT greater than or equal to 2.5 times upper limit of normal\n* Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma\n* History of pancreatitis (acute or chronic)\n* Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before the day of screening\n* Anticipated initiation or change in concomitant medications for more than 14 consecutive days or on a frequent basis known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids)'}, 'identificationModule': {'nctId': 'NCT02501161', 'acronym': 'DUAL™ VIII', 'briefTitle': 'A 104 Week Clinical Trial Comparing Long Term Glycaemic Control of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine Therapy in Subjects With Type 2 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Clinical Trial Comparing Long Term Glycaemic Control of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine Therapy in Subjects With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'NN9068-4228'}, 'secondaryIdInfos': [{'id': '2014-005639-15', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1165-3914', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Insulin degludec/liraglutide QD + OAD(s)', 'interventionNames': ['Drug: insulin degludec/liraglutide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'insulin glargine QD + OAD(s)', 'interventionNames': ['Drug: insulin glargine']}], 'interventions': [{'name': 'insulin degludec/liraglutide', 'type': 'DRUG', 'description': 'Injected subcutaneously (under the skin) once daily for 104 weeks. Dose individually adjusted.', 'armGroupLabels': ['Insulin degludec/liraglutide QD + OAD(s)']}, {'name': 'insulin glargine', 'type': 'DRUG', 'description': 'Injected subcutaneously (under the skin) once daily for 104 weeks. Dose individually adjusted.', 'armGroupLabels': ['insulin glargine QD + OAD(s)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35662', 'city': 'Muscle Shoals', 'state': 'Alabama', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 34.74481, 'lon': -87.66753}}, {'zip': '35674', 'city': 'Tuscumbia', 'state': 'Alabama', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 34.7312, 'lon': -87.70253}}, {'zip': '85306-4652', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': '85308', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': '85018', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85020', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85050', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92203', 'city': 'Bermuda Dunes', 'state': 'California', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 33.7428, 'lon': -116.28918}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '93534', 'city': 'Lancaster', 'state': 'California', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 34.69804, 'lon': -118.13674}}, {'zip': '93940', 'city': 'Monterey', 'state': 'California', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 36.60024, 'lon': -121.89468}}, {'zip': '95821', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '91978', 'city': 'Spring Valley', 'state': 'California', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 32.74477, 'lon': -116.99892}}, {'zip': '93003', 'city': 'Ventura', 'state': 'California', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 34.27834, 'lon': -119.29317}}, {'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '80910', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '33472', 'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'zip': '33461', 'city': 'Lake Worth', 'state': 'Florida', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 26.61708, 'lon': -80.07231}}, {'zip': '33135', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '83221', 'city': 'Blackfoot', 'state': 'Idaho', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 43.19047, 'lon': -112.34498}}, {'zip': '46123', 'city': 'Avon', 'state': 'Indiana', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 39.76282, 'lon': -86.39972}}, {'zip': '46254', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '70002', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '20782', 'city': 'Hyattsville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 38.95594, 'lon': -76.94553}}, {'zip': '20852', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': '02453', 'city': 'Waltham', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 42.37649, 'lon': -71.23561}}, {'zip': '49620', 'city': 'Buckley', 'state': 'Michigan', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 44.50445, 'lon': -85.67701}}, {'zip': '59101', 'city': 'Billings', 'state': 'Montana', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 45.78329, 'lon': -108.50069}}, {'zip': '03063', 'city': 'Nashua', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 42.76537, 'lon': -71.46757}}, {'zip': '87102', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '12553', 'city': 'New Windsor', 'state': 'New York', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 41.47676, 'lon': -74.02375}}, {'zip': '45040-6815', 'city': 'Mason', 'state': 'Ohio', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 39.36006, 'lon': -84.30994}}, {'zip': '43537', 'city': 'Maumee', 'state': 'Ohio', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 41.56283, 'lon': -83.65382}}, {'zip': '15009', 'city': 'Beaver', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 40.69534, 'lon': -80.30478}}, {'zip': '29651', 'city': 'Greer', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 34.93873, 'lon': -82.22706}}, {'zip': '38343', 'city': 'Humboldt', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 35.81979, 'lon': -88.9159}}, {'zip': '75251', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77040', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '75061-2210', 'city': 'Irving', 'state': 'Texas', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 32.81402, 'lon': -96.94889}}, {'zip': '77450', 'city': 'Katy', 'state': 'Texas', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 29.78579, 'lon': -95.8244}}, {'zip': '78215', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '23114', 'city': 'Midlothian', 'state': 'Virginia', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 37.50598, 'lon': -77.64916}}, {'zip': '53142', 'city': 'Kenosha', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 42.58474, 'lon': -87.82119}}, {'zip': '53144', 'city': 'Kenosha', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 42.58474, 'lon': -87.82119}}, {'zip': 'C1425AGC', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1179AAB', 'city': 'CABA', 'country': 'Argentina', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': 'C1056ABJ', 'city': 'Capital Federal', 'country': 'Argentina', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '5500', 'city': 'Mendoza', 'country': 'Argentina', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -32.88946, 'lon': -68.84582}}, {'zip': '01228-000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '90035-170', 'city': 'Porto Alegre', 'country': 'Brazil', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '30100', 'city': 'Pilsen', 'country': 'Czechia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 49.74747, 'lon': 13.37759}}, {'zip': '32600', 'city': 'Pilsen', 'country': 'Czechia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 49.74747, 'lon': 13.37759}}, {'zip': '11694', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '140 46', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '1106', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': 'H-1134', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '2400', 'city': 'Dunaújváros', 'country': 'Hungary', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 46.96479, 'lon': 18.93974}}, {'zip': '7400', 'city': 'Kaposvár', 'country': 'Hungary', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 46.36667, 'lon': 17.8}}, {'zip': 'H-7624', 'city': 'Pécs', 'country': 'Hungary', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 46.07617, 'lon': 18.22814}}, {'zip': '500003', 'city': 'Secunderabad', 'state': 'Andhra Pradesh', 'country': 'India', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '530002', 'city': 'Visakhapatnam', 'state': 'Andhra Pradesh', 'country': 'India', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 17.68009, 'lon': 83.20161}}, {'zip': '124001', 'city': 'Rohtak', 'state': 'Haryana', 'country': 'India', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 28.89447, 'lon': 76.58917}}, {'zip': '560054', 'city': 'Bangalore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '400058', 'city': 'Mumbai', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'zip': '440015', 'city': 'Nagpur', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 21.14631, 'lon': 79.08491}}, {'zip': '411001', 'city': 'Pune', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'zip': '411040', 'city': 'Pune', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'zip': '110002', 'city': 'Delhi', 'state': 'New Delhi', 'country': 'India', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 28.65195, 'lon': 77.23149}}, {'zip': '302006', 'city': 'Jaipur', 'state': 'Rajasthan', 'country': 'India', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 26.91962, 'lon': 75.78781}}, {'zip': '641018', 'city': 'Coimbatore', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 11.00555, 'lon': 76.96612}}, {'zip': '700020', 'city': 'Kolkata', 'state': 'West Bengal', 'country': 'India', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 22.56263, 'lon': 88.36304}}, {'zip': '700107', 'city': 'Kolkata', 'state': 'West Bengal', 'country': 'India', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 22.56263, 'lon': 88.36304}}, {'zip': '35152', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'city': 'Haifa', 'country': 'Israel', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '22100', 'city': 'Nahariya', 'country': 'Israel', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 33.00892, 'lon': 35.09814}}, {'zip': '75650', 'city': 'Rishon LeZiyyon', 'country': 'Israel', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 31.97102, 'lon': 34.78939}}, {'zip': '62038', 'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'zip': '6789714', 'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'zip': '52621', 'city': 'Tel Litwinsky', 'country': 'Israel', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}, {'zip': '70300', 'city': 'Ẕerifin', 'country': 'Israel', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 31.95731, 'lon': 34.84852}}, {'zip': '40138', 'city': 'Bologna', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '88100', 'city': 'Catanzaro', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 38.88247, 'lon': 16.60086}}, {'zip': '35013', 'city': 'Cittadella (PD)', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 45.64523, 'lon': 11.78453}}, {'zip': '37024', 'city': 'Negrar (VR)', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 45.52918, 'lon': 10.93899}}, {'zip': '90129', 'city': 'Palermo', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'zip': '27100', 'city': 'Pavia', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'zip': '37126', 'city': 'Verona', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}, {'zip': '44600', 'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': '62250', 'city': 'Cuernavaca', 'state': 'Morelos', 'country': 'Mexico', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 18.9261, 'lon': -99.23075}}, {'zip': '89440', 'city': 'Ciudad Madero', 'state': 'Tamaulipas', 'country': 'Mexico', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 22.2475, 'lon': -97.83665}}, {'zip': '34000', 'city': 'Durango', 'country': 'Mexico', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 24.02032, 'lon': -104.65756}}, {'zip': '8005', 'city': 'Bodø', 'country': 'Norway', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 67.28267, 'lon': 14.37513}}, {'zip': '2317', 'city': 'Hamar', 'country': 'Norway', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 60.7945, 'lon': 11.06798}}, {'zip': '3515', 'city': 'Hoenefoss', 'country': 'Norway', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '2040', 'city': 'Kløfta', 'country': 'Norway', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 60.07407, 'lon': 11.13805}}, {'zip': '3420', 'city': 'Lierskogen', 'country': 'Norway', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 59.81978, 'lon': 10.33084}}, {'zip': '0424', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'zip': '4005', 'city': 'Stavanger', 'country': 'Norway', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 58.97005, 'lon': 5.73332}}, {'zip': '4056', 'city': 'Tananger', 'country': 'Norway', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 58.93618, 'lon': 5.5741}}, {'zip': '15-276', 'city': 'Bialystok', 'country': 'Poland', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'zip': '80-858', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '41-800', 'city': 'Zabrze', 'country': 'Poland', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 50.32492, 'lon': 18.78576}}, {'zip': '119121', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '119435', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '630117', 'city': 'Novosibirsk', 'country': 'Russia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}, {'zip': '440026', 'city': 'Penza', 'country': 'Russia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 53.19568, 'lon': 45.01075}}, {'zip': '194354', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '194358', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '195213', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '355035', 'city': 'Stavropol', 'country': 'Russia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 45.03442, 'lon': 41.9642}}, {'zip': '97101', 'city': 'Prievidza', 'country': 'Slovakia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 48.77446, 'lon': 18.6275}}, {'zip': '08301', 'city': 'Sabinov', 'country': 'Slovakia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 49.10309, 'lon': 21.0988}}, {'zip': '07501', 'city': 'Trebišov', 'country': 'Slovakia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 48.62858, 'lon': 21.71954}}, {'zip': '911 01', 'city': 'Trenčín', 'country': 'Slovakia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 48.89452, 'lon': 18.04436}}, {'zip': '91701', 'city': 'Trnava', 'country': 'Slovakia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 48.37773, 'lon': 17.58603}}, {'zip': '2188', 'city': 'Cosmo City', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '1818', 'city': 'Johannesburg', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'zip': '0002', 'city': 'Pretoria', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'zip': '0083', 'city': 'Pretoria', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'zip': '0183', 'city': 'Pretoria', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'zip': '4001', 'city': 'Durban', 'state': 'KwaZulu-Natal', 'country': 'South Africa', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -29.8579, 'lon': 31.0292}}, {'zip': '4170', 'city': 'Durban', 'state': 'KwaZulu-Natal', 'country': 'South Africa', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -29.8579, 'lon': 31.0292}}, {'zip': '4170', 'city': 'eMkhomazi', 'state': 'KwaZulu-Natal', 'country': 'South Africa', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -30.20672, 'lon': 30.79641}}, {'zip': '0250', 'city': 'Brits', 'state': 'North West', 'country': 'South Africa', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -25.63473, 'lon': 27.78022}}, {'zip': '7700', 'city': 'Cape Town', 'state': 'Western Cape', 'country': 'South Africa', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '1449', 'city': 'Alberton', 'country': 'South Africa', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -26.26786, 'lon': 28.12225}}, {'zip': '06100', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'city': 'Bursa', 'country': 'Turkey (Türkiye)', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 40.19559, 'lon': 29.06013}}, {'zip': '34096', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '34390', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '34718', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '34899', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '53020', 'city': 'Rize', 'country': 'Turkey (Türkiye)', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 41.02083, 'lon': 40.52194}}, {'zip': '55139', 'city': 'Samsun', 'country': 'Turkey (Türkiye)', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 41.27976, 'lon': 36.3361}}, {'zip': 'DD8 2AS', 'city': 'Angus', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': 'CV2 2DX', 'city': 'Coventry', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 52.40656, 'lon': -1.51217}}, {'zip': 'DY1 2HQ', 'city': 'Dudley', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 52.5, 'lon': -2.08333}}, {'zip': 'DD4 6QY', 'city': 'Dundee', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 56.46913, 'lon': -2.97489}}, {'zip': 'KY14 6AW', 'city': 'Fife', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': 'HU3 2RW', 'city': 'Hull', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 53.7446, 'lon': -0.33525}}, {'zip': 'S60 2UD', 'city': 'Rotherham', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 53.43012, 'lon': -1.35678}}, {'zip': 'TQ2 7AA', 'city': 'Torquay', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 50.46198, 'lon': -3.52522}}, {'zip': 'WV10 0QP', 'city': 'Wolverhampton', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 52.58547, 'lon': -2.12296}}], 'overallOfficials': [{'name': 'Global Clinical Registry GCR, 1452', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}