Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2026-01-25 @ 1:01 AM
Study NCT ID:
NCT02648204
Status:
COMPLETED
Last Update Posted:
2019-10-15
First Post:
2016-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Semaglutide Versus Dulaglutide as add-on to Metformin in Subjects With Type 2 Diabetes.
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': 'C000591245', 'term': 'semaglutide'}, {'id': 'C555680', 'term': 'dulaglutide'}]}}, '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': 'Baseline (week 0) to week 40 + follow up of 5 weeks (including a visit window of +7 days)', 'description': "A TEAE was defined as an AE with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected from first administration of trial product until the follow-up (5 weeks after the last treatment including a visit window of +7 days)", 'eventGroups': [{'id': 'EG000', 'title': 'Semaglutide 0.5 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).', 'otherNumAtRisk': 301, 'deathsNumAtRisk': 301, 'otherNumAffected': 132, 'seriousNumAtRisk': 301, 'deathsNumAffected': 0, 'seriousNumAffected': 17}, {'id': 'EG001', 'title': 'Semaglutide 1.0 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.', 'otherNumAtRisk': 300, 'deathsNumAtRisk': 300, 'otherNumAffected': 134, 'seriousNumAtRisk': 300, 'deathsNumAffected': 1, 'seriousNumAffected': 23}, {'id': 'EG002', 'title': 'Dulaglutide 0.75 mg', 'description': 'Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.', 'otherNumAtRisk': 299, 'deathsNumAtRisk': 299, 'otherNumAffected': 106, 'seriousNumAtRisk': 299, 'deathsNumAffected': 2, 'seriousNumAffected': 24}, {'id': 'EG003', 'title': 'Dulaglutide 1.5 mg', 'description': 'Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.', 'otherNumAtRisk': 299, 'deathsNumAtRisk': 299, 'otherNumAffected': 139, 'seriousNumAtRisk': 299, 'deathsNumAffected': 2, 'seriousNumAffected': 22}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 18, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 18, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 26, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 27, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 36, 'numAffected': 31}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 79, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 96, 'numAffected': 41}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 42, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 75, 'numAffected': 53}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 35, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 30, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 20, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 30, 'numAffected': 19}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 23, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 20, 'numAffected': 17}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 20, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 24, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 144, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 192, 'numAffected': 63}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 66, 'numAffected': 39}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 108, 'numAffected': 60}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 18, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 26, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 21, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 50, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 48, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 16, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 40, 'numAffected': 29}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19'}], 'seriousEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19'}, {'term': 'Acute vestibular syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19'}, {'term': 'Aortic valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19'}, {'term': 'Cardioversion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19'}, {'term': 'Carpal tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19'}, {'term': 'Congestive cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19'}, {'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19'}, {'term': 'Cystocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, 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'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19'}, {'term': 'Rectal adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19'}, {'term': 'Rectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19'}, {'term': 'Rectal prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19'}, {'term': 'Sarcoidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19'}, {'term': 'Spinal column stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19'}, {'term': 'Ureterolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19'}, {'term': 'Uterine prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in HbA1c', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '299', 'groupId': 'OG002'}, {'value': '299', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 0.5 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).'}, {'id': 'OG001', 'title': 'Semaglutide 1.0 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'OG002', 'title': 'Dulaglutide 0.75 mg', 'description': 'Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'OG003', 'title': 'Dulaglutide 1.5 mg', 'description': 'Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.51', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-1.78', 'spread': '0.06', 'groupId': 'OG001'}, {'value': '-1.11', 'spread': '0.05', 'groupId': 'OG002'}, {'value': '-1.37', 'spread': '0.06', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.40', 'ciLowerLimit': '-0.55', 'ciUpperLimit': '-0.25', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-Inferiority margin: 0.4'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.40', 'ciLowerLimit': '-0.55', 'ciUpperLimit': '-0.25', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.41', 'ciLowerLimit': '-0.57', 'ciUpperLimit': '-0.25', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-Inferiority margin: 0.04'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.41', 'ciLowerLimit': '-0.57', 'ciUpperLimit': '-0.25', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 0, week 40', 'description': "Results are based on HbA1c data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on-treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.", 'unitOfMeasure': 'percentage of HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on FAS.'}, {'type': 'SECONDARY', 'title': 'Change in Body Weight (kg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '299', 'groupId': 'OG002'}, {'value': '298', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 0.5 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).'}, {'id': 'OG001', 'title': 'Semaglutide 1.0 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'OG002', 'title': 'Dulaglutide 0.75 mg', 'description': 'Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'OG003', 'title': 'Dulaglutide 1.5 mg', 'description': 'Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.56', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '-6.53', 'spread': '0.28', 'groupId': 'OG001'}, {'value': '-2.30', 'spread': '0.27', 'groupId': 'OG002'}, {'value': '-2.98', 'spread': '0.27', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.26', 'ciLowerLimit': '-3.02', 'ciUpperLimit': '-1.51', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.39', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.55', 'ciLowerLimit': '-4.32', 'ciUpperLimit': '-2.78', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.39', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 0, week 40', 'description': "Results are based on body weight data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication.", 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on FAS. Number of subjects analysed=number of subjects with available data for body weight.'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Plasma Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}, {'value': '297', 'groupId': 'OG002'}, {'value': '297', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 0.5 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).'}, {'id': 'OG001', 'title': 'Semaglutide 1.0 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'OG002', 'title': 'Dulaglutide 0.75 mg', 'description': 'Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'OG003', 'title': 'Dulaglutide 1.5 mg', 'description': 'Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.18', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '-2.83', 'spread': '0.12', 'groupId': 'OG001'}, {'value': '-1.87', 'spread': '0.12', 'groupId': 'OG002'}, {'value': '-2.25', 'spread': '0.12', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 0, week 40', 'description': "Results are based on fasting plasma glucose data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication.", 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on FAS. Number of participants analysed=number of participants with available data for fasting plasma glucose.'}, {'type': 'SECONDARY', 'title': 'Change in Systolic and Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '299', 'groupId': 'OG002'}, {'value': '299', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 0.5 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).'}, {'id': 'OG001', 'title': 'Semaglutide 1.0 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'OG002', 'title': 'Dulaglutide 0.75 mg', 'description': 'Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'OG003', 'title': 'Dulaglutide 1.5 mg', 'description': 'Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}], 'classes': [{'title': 'Diastolic BP', 'categories': [{'measurements': [{'value': '-0.57', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '-2.05', 'spread': '0.49', 'groupId': 'OG001'}, {'value': '-0.35', 'spread': '0.47', 'groupId': 'OG002'}, {'value': '-0.03', 'spread': '0.47', 'groupId': 'OG003'}]}]}, {'title': 'Systolic BP', 'categories': [{'measurements': [{'value': '-2.44', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '-4.88', 'spread': '0.77', 'groupId': 'OG001'}, {'value': '-2.16', 'spread': '0.75', 'groupId': 'OG002'}, {'value': '-2.86', 'spread': '0.75', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 0, week 40', 'description': "Results are based on systolic and diastolic blood pressure data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication.", 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on FAS.'}, {'type': 'SECONDARY', 'title': 'Change in Overall Scores for Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}, {'value': '299', 'groupId': 'OG002'}, {'value': '298', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 0.5 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).'}, {'id': 'OG001', 'title': 'Semaglutide 1.0 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'OG002', 'title': 'Dulaglutide 0.75 mg', 'description': 'Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'OG003', 'title': 'Dulaglutide 1.5 mg', 'description': 'Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.60', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '4.55', 'spread': '0.29', 'groupId': 'OG001'}, {'value': '4.52', 'spread': '0.28', 'groupId': 'OG002'}, {'value': '4.65', 'spread': '0.28', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 0, week 40', 'description': "The questionnaire contains 8 items and evaluates subjects' diabetes treatment in terms of convenience, flexibility and general feelings towards treatment. The result presented is 'Treatment Satisfaction' summary score (sum of 6 of the 8 items). Response options: 6 (best case) to 0 (worst case). Total scores range: 0-36. Higher scores=higher satisfaction. Results are based on data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This includes observations recorded at, or after the date of first dose of trial product and not after first occurrence of following: the end-date of the 'on-treatment' observation period or initiation of rescue medication", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on FAS. Number of participants analysed=number of participants with available data for diabetes treatment satisfaction questionnaire'}, {'type': 'SECONDARY', 'title': 'HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists Target', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '299', 'groupId': 'OG002'}, {'value': '299', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 0.5 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).'}, {'id': 'OG001', 'title': 'Semaglutide 1.0 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'OG002', 'title': 'Dulaglutide 0.75 mg', 'description': 'Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'OG003', 'title': 'Dulaglutide 1.5 mg', 'description': 'Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '49.2', 'groupId': 'OG000'}, {'value': '66.7', 'groupId': 'OG001'}, {'value': '34.1', 'groupId': 'OG002'}, {'value': '47.2', 'groupId': 'OG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '50.8', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}, {'value': '65.9', 'groupId': 'OG002'}, {'value': '52.8', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After 40 weeks treatment', 'description': "Percentage of subjects who achieved HbA1c target below or equal to 6.5% (48 mmol/mol) after 40 weeks of treatment. Results are based on data from on-treatment without rescue medication period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.", 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Results are based on the FAS.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 7-point Self-measured Plasma Glucose (SMPG) Mean Profile', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '295', 'groupId': 'OG001'}, {'value': '296', 'groupId': 'OG002'}, {'value': '296', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 0.5 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).'}, {'id': 'OG001', 'title': 'Semaglutide 1.0 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'OG002', 'title': 'Dulaglutide 0.75 mg', 'description': 'Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'OG003', 'title': 'Dulaglutide 1.5 mg', 'description': 'Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.43', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '-2.95', 'spread': '0.10', 'groupId': 'OG001'}, {'value': '-1.99', 'spread': '0.10', 'groupId': 'OG002'}, {'value': '-2.32', 'spread': '0.10', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 0, week 40', 'description': "SMPG values were recorded at 7 time-points: before and 90 minutes after start of breakfast, lunch, and dinner, and at bedtime. Reported results are mean profile from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.", 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on FAS. Number of participants analysed=Number of participants analysed=number of participants with available data for 7-point self-measured plasma glucose.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline 7-point Self-measured Plasma Glucose Increment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}, {'value': '296', 'groupId': 'OG002'}, {'value': '296', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 0.5 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).'}, {'id': 'OG001', 'title': 'Semaglutide 1.0 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'OG002', 'title': 'Dulaglutide 0.75 mg', 'description': 'Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'OG003', 'title': 'Dulaglutide 1.5 mg', 'description': 'Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.77', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '-0.93', 'spread': '0.09', 'groupId': 'OG001'}, {'value': '-0.44', 'spread': '0.08', 'groupId': 'OG002'}, {'value': '-0.63', 'spread': '0.08', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 0, week 40', 'description': "SMPG values were recorded at 7 time-points: before and 90 minutes after start of breakfast, lunch, and dinner, and at bedtime. Reported results are plasma glucose incremental profile from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes observations recorded at, or after date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit", 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on FAS. Number of participants analysed=number of participants with available data for 7-point self-measured plasma glucose increment.'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Blood Lipids (Total Cholesterol)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '296', 'groupId': 'OG001'}, {'value': '290', 'groupId': 'OG002'}, {'value': '294', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 0.5 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).'}, {'id': 'OG001', 'title': 'Semaglutide 1.0 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'OG002', 'title': 'Dulaglutide 0.75 mg', 'description': 'Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'OG003', 'title': 'Dulaglutide 1.5 mg', 'description': 'Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.96', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '0.97', 'spread': '0.01', 'groupId': 'OG001'}, {'value': '0.97', 'spread': '0.01', 'groupId': 'OG002'}, {'value': '0.99', 'spread': '0.01', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_LEAST_SQUARES_MEAN', 'timeFrame': 'Week 0, week 40', 'description': "Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value.", 'unitOfMeasure': 'ratio to baseline', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on FAS. Number of participants analysed=number of participants with available data for total cholesterol'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Blood Lipids (Low Density Lipoprotein [LDL] Cholesterol)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '293', 'groupId': 'OG000'}, {'value': '295', 'groupId': 'OG001'}, {'value': '290', 'groupId': 'OG002'}, {'value': '294', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 0.5 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).'}, {'id': 'OG001', 'title': 'Semaglutide 1.0 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'OG002', 'title': 'Dulaglutide 0.75 mg', 'description': 'Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'OG003', 'title': 'Dulaglutide 1.5 mg', 'description': 'Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.97', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '0.02', 'groupId': 'OG001'}, {'value': '0.97', 'spread': '0.02', 'groupId': 'OG002'}, {'value': '1.01', 'spread': '0.02', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_LEAST_SQUARES_MEAN', 'timeFrame': 'Week 0, week 40', 'description': "Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value.", 'unitOfMeasure': 'ratio to baseline', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on FAS. Number of participants analysed=number of participants with available data for LDL cholesterol.'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Blood Lipids (High Density Lipoprotein [HDL] Cholesterol)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '293', 'groupId': 'OG000'}, {'value': '296', 'groupId': 'OG001'}, {'value': '290', 'groupId': 'OG002'}, {'value': '294', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 0.5 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).'}, {'id': 'OG001', 'title': 'Semaglutide 1.0 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'OG002', 'title': 'Dulaglutide 0.75 mg', 'description': 'Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'OG003', 'title': 'Dulaglutide 1.5 mg', 'description': 'Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.99', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '1.01', 'spread': '0.01', 'groupId': 'OG001'}, {'value': '1.00', 'spread': '0.01', 'groupId': 'OG002'}, {'value': '1.02', 'spread': '0.01', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_LEAST_SQUARES_MEAN', 'timeFrame': 'Week 0, week 40', 'description': "Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value.", 'unitOfMeasure': 'ratio to baseline', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on FAS. Number of participants analysed=number of participants with available data for HDL cholesterol.'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Blood Lipids (Triglycerides)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '293', 'groupId': 'OG000'}, {'value': '296', 'groupId': 'OG001'}, {'value': '290', 'groupId': 'OG002'}, {'value': '294', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 0.5 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).'}, {'id': 'OG001', 'title': 'Semaglutide 1.0 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'OG002', 'title': 'Dulaglutide 0.75 mg', 'description': 'Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'OG003', 'title': 'Dulaglutide 1.5 mg', 'description': 'Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.91', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '0.86', 'spread': '0.02', 'groupId': 'OG001'}, {'value': '0.91', 'spread': '0.02', 'groupId': 'OG002'}, {'value': '0.90', 'spread': '0.02', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_LEAST_SQUARES_MEAN', 'timeFrame': 'Week 0, week 40', 'description': "Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value.", 'unitOfMeasure': 'ratio to baseline', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on FAS. Number of participants analysed=number of participants with available data for triglycerides.'}, {'type': 'SECONDARY', 'title': 'Change in Body Mass Index (BMI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '299', 'groupId': 'OG002'}, {'value': '298', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 0.5 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).'}, {'id': 'OG001', 'title': 'Semaglutide 1.0 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'OG002', 'title': 'Dulaglutide 0.75 mg', 'description': 'Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'OG003', 'title': 'Dulaglutide 1.5 mg', 'description': 'Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.63', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '-2.33', 'spread': '0.10', 'groupId': 'OG001'}, {'value': '-0.82', 'spread': '0.10', 'groupId': 'OG002'}, {'value': '-1.08', 'spread': '0.10', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 0, week 40', 'description': "Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.", 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on FAS. Number of participants analysed=number of participants with available data for BMI.'}, {'type': 'SECONDARY', 'title': 'Change in Waist Circumference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '298', 'groupId': 'OG002'}, {'value': '297', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 0.5 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).'}, {'id': 'OG001', 'title': 'Semaglutide 1.0 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'OG002', 'title': 'Dulaglutide 0.75 mg', 'description': 'Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'OG003', 'title': 'Dulaglutide 1.5 mg', 'description': 'Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.27', 'spread': '0.34', 'groupId': 'OG000'}, {'value': '-5.20', 'spread': '0.34', 'groupId': 'OG001'}, {'value': '-2.36', 'spread': '0.33', 'groupId': 'OG002'}, {'value': '-2.93', 'spread': '0.33', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 0, week 40', 'description': "Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.", 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on FAS. Number of participants analysed=number of participants with available data for waist circumference.'}, {'type': 'SECONDARY', 'title': 'Change in Short Form Health Survey (SF-36v2™)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '299', 'groupId': 'OG002'}, {'value': '299', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 0.5 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).'}, {'id': 'OG001', 'title': 'Semaglutide 1.0 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'OG002', 'title': 'Dulaglutide 0.75 mg', 'description': 'Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'OG003', 'title': 'Dulaglutide 1.5 mg', 'description': 'Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}], 'classes': [{'title': 'Physical component summary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}, {'value': '295', 'groupId': 'OG002'}, {'value': '298', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.21', 'spread': '0.40', 'groupId': 'OG000'}, {'value': '2.04', 'spread': '0.40', 'groupId': 'OG001'}, {'value': '1.93', 'spread': '0.39', 'groupId': 'OG002'}, {'value': '1.29', 'spread': '0.39', 'groupId': 'OG003'}]}]}, {'title': 'Mental component summary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}, {'value': '295', 'groupId': 'OG002'}, {'value': '298', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.45', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '1.23', 'spread': '0.49', 'groupId': 'OG001'}, {'value': '0.95', 'spread': '0.48', 'groupId': 'OG002'}, {'value': '1.08', 'spread': '0.48', 'groupId': 'OG003'}]}]}, {'title': 'Physical functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '298', 'groupId': 'OG002'}, {'value': '299', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.25', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '2.00', 'spread': '0.44', 'groupId': 'OG001'}, {'value': '2.17', 'spread': '0.43', 'groupId': 'OG002'}, {'value': '1.05', 'spread': '0.43', 'groupId': 'OG003'}]}]}, {'title': 'Role-physical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}, {'value': '298', 'groupId': 'OG002'}, {'value': '299', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.98', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '2.03', 'spread': '0.48', 'groupId': 'OG001'}, {'value': '1.39', 'spread': '0.47', 'groupId': 'OG002'}, {'value': '0.82', 'spread': '0.47', 'groupId': 'OG003'}]}]}, {'title': 'Bodily pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}, {'value': '299', 'groupId': 'OG002'}, {'value': '299', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.96', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '1.54', 'spread': '0.52', 'groupId': 'OG001'}, {'value': '1.69', 'spread': '0.51', 'groupId': 'OG002'}, {'value': '0.77', 'spread': '0.51', 'groupId': 'OG003'}]}]}, {'title': 'General health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}, {'value': '298', 'groupId': 'OG002'}, {'value': '299', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.65', 'spread': '0.43', 'groupId': 'OG000'}, {'value': '2.52', 'spread': '0.43', 'groupId': 'OG001'}, {'value': '1.86', 'spread': '0.42', 'groupId': 'OG002'}, {'value': '2.73', 'spread': '0.42', 'groupId': 'OG003'}]}]}, {'title': 'Vitality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}, {'value': '299', 'groupId': 'OG002'}, {'value': '299', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.23', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '1.97', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '2.14', 'spread': '0.49', 'groupId': 'OG002'}, {'value': '1.83', 'spread': '0.50', 'groupId': 'OG003'}]}]}, {'title': 'Social functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}, {'value': '299', 'groupId': 'OG002'}, {'value': '299', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.18', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '0.83', 'spread': '0.49', 'groupId': 'OG001'}, {'value': '0.78', 'spread': '0.48', 'groupId': 'OG002'}, {'value': '0.63', 'spread': '0.48', 'groupId': 'OG003'}]}]}, {'title': 'Role-emotional', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}, {'value': '297', 'groupId': 'OG002'}, {'value': '298', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.11', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '1.57', 'spread': '0.58', 'groupId': 'OG001'}, {'value': '1.04', 'spread': '0.56', 'groupId': 'OG002'}, {'value': '1.08', 'spread': '0.57', 'groupId': 'OG003'}]}]}, {'title': 'Mental health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}, {'value': '299', 'groupId': 'OG002'}, {'value': '299', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.89', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '1.65', 'spread': '0.49', 'groupId': 'OG001'}, {'value': '1.43', 'spread': '0.48', 'groupId': 'OG002'}, {'value': '0.96', 'spread': '0.48', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 0, week 40', 'description': "The questionnaire contains 36 items across 8 domains and 2 summary scores. Score range: 0 (worst score) to 100 (best score). Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on FAS. Number analysed=number of participants with available data for SF-36.'}, {'type': 'SECONDARY', 'title': 'Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c <7.0% (53 mmol/Mol) American Diabetes Association (ADA) Target', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '299', 'groupId': 'OG002'}, {'value': '299', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 0.5 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).'}, {'id': 'OG001', 'title': 'Semaglutide 1.0 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'OG002', 'title': 'Dulaglutide 0.75 mg', 'description': 'Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'OG003', 'title': 'Dulaglutide 1.5 mg', 'description': 'Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '68.4', 'groupId': 'OG000'}, {'value': '78.7', 'groupId': 'OG001'}, {'value': '52.2', 'groupId': 'OG002'}, {'value': '66.6', 'groupId': 'OG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '31.6', 'groupId': 'OG000'}, {'value': '21.3', 'groupId': 'OG001'}, {'value': '47.8', 'groupId': 'OG002'}, {'value': '33.4', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After 40 weeks of treatment', 'description': "Percentage of subjects who achieved HbA1c target below or equal to \\<7.0% (53 mmol/mol) after 40 weeks of treatment. Results are based on data from on-treatment without rescue medication period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.", 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on FAS.'}, {'type': 'SECONDARY', 'title': 'Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥5%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '299', 'groupId': 'OG002'}, {'value': '298', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 0.5 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).'}, {'id': 'OG001', 'title': 'Semaglutide 1.0 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'OG002', 'title': 'Dulaglutide 0.75 mg', 'description': 'Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'OG003', 'title': 'Dulaglutide 1.5 mg', 'description': 'Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '43.9', 'groupId': 'OG000'}, {'value': '63.0', 'groupId': 'OG001'}, {'value': '22.7', 'groupId': 'OG002'}, {'value': '30.2', 'groupId': 'OG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '56.1', 'groupId': 'OG000'}, {'value': '37.0', 'groupId': 'OG001'}, {'value': '77.3', 'groupId': 'OG002'}, {'value': '69.8', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After 40 weeks treatment', 'description': "Percentage of subjects who achieved weight loss ≥5% after 40 weeks of treatment. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.", 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on FAS. Number of participants analysed=number of participants with available data for body weight.'}, {'type': 'SECONDARY', 'title': 'Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥10%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '299', 'groupId': 'OG002'}, {'value': '298', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 0.5 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).'}, {'id': 'OG001', 'title': 'Semaglutide 1.0 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'OG002', 'title': 'Dulaglutide 0.75 mg', 'description': 'Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'OG003', 'title': 'Dulaglutide 1.5 mg', 'description': 'Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000'}, {'value': '26.7', 'groupId': 'OG001'}, {'value': '3.3', 'groupId': 'OG002'}, {'value': '7.7', 'groupId': 'OG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '85.7', 'groupId': 'OG000'}, {'value': '73.3', 'groupId': 'OG001'}, {'value': '96.7', 'groupId': 'OG002'}, {'value': '92.3', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After 40 weeks treatment', 'description': "Percentage of subjects who achieved weight loss ≥10% after 40 weeks of treatment. Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.", 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on FAS. Number of participants analysed=number of participants with available data for body weight'}, {'type': 'SECONDARY', 'title': 'Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c <7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '299', 'groupId': 'OG002'}, {'value': '298', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 0.5 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).'}, {'id': 'OG001', 'title': 'Semaglutide 1.0 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'OG002', 'title': 'Dulaglutide 0.75 mg', 'description': 'Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'OG003', 'title': 'Dulaglutide 1.5 mg', 'description': 'Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '64.5', 'groupId': 'OG000'}, {'value': '74.0', 'groupId': 'OG001'}, {'value': '44.1', 'groupId': 'OG002'}, {'value': '58.4', 'groupId': 'OG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '35.5', 'groupId': 'OG000'}, {'value': '26.0', 'groupId': 'OG001'}, {'value': '55.9', 'groupId': 'OG002'}, {'value': '41.6', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After 40 weeks of treatment', 'description': "Percentage of subjects achieved (yes/no) HbA1c \\<7.0% (53 mmol/mol) without severe or BG confirmed symptomatic hypoglycaemia episodes and no weight gain after 40 weeks of treatment. Results are based on data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was subset of 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit", 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on FAS. Number of participants analysed=number of participants with available data for this endpoint.'}, {'type': 'SECONDARY', 'title': 'Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c Reduction ≥1%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '299', 'groupId': 'OG002'}, {'value': '299', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 0.5 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).'}, {'id': 'OG001', 'title': 'Semaglutide 1.0 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'OG002', 'title': 'Dulaglutide 0.75 mg', 'description': 'Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'OG003', 'title': 'Dulaglutide 1.5 mg', 'description': 'Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '77.4', 'groupId': 'OG000'}, {'value': '83.3', 'groupId': 'OG001'}, {'value': '53.8', 'groupId': 'OG002'}, {'value': '67.6', 'groupId': 'OG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '22.6', 'groupId': 'OG000'}, {'value': '16.7', 'groupId': 'OG001'}, {'value': '46.2', 'groupId': 'OG002'}, {'value': '32.4', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After 40 weeks of treatment', 'description': "Percentage of subjects who achieved (yes/no) HbA1c reduction of ≥1% after 40 weeks of treatment. Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.", 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on FAS.'}, {'type': 'SECONDARY', 'title': 'Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥3%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '299', 'groupId': 'OG002'}, {'value': '298', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 0.5 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).'}, {'id': 'OG001', 'title': 'Semaglutide 1.0 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'OG002', 'title': 'Dulaglutide 0.75 mg', 'description': 'Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'OG003', 'title': 'Dulaglutide 1.5 mg', 'description': 'Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '64.5', 'groupId': 'OG000'}, {'value': '76.7', 'groupId': 'OG001'}, {'value': '36.5', 'groupId': 'OG002'}, {'value': '44.6', 'groupId': 'OG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '35.5', 'groupId': 'OG000'}, {'value': '23.3', 'groupId': 'OG001'}, {'value': '63.5', 'groupId': 'OG002'}, {'value': '55.4', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After 40 weeks treatment', 'description': "Percentage of subjects who achieved (yes/no) weight loss of ≥3% after 40 weeks of treatment. Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.", 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on FAS. Number of participants analysed=number of participants with available data for body weight'}, {'type': 'SECONDARY', 'title': 'Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c Reduction ≥1% and Weight Loss ≥3%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '299', 'groupId': 'OG002'}, {'value': '298', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 0.5 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).'}, {'id': 'OG001', 'title': 'Semaglutide 1.0 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'OG002', 'title': 'Dulaglutide 0.75 mg', 'description': 'Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'OG003', 'title': 'Dulaglutide 1.5 mg', 'description': 'Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '53.2', 'groupId': 'OG000'}, {'value': '68.3', 'groupId': 'OG001'}, {'value': '25.1', 'groupId': 'OG002'}, {'value': '34.9', 'groupId': 'OG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '46.8', 'groupId': 'OG000'}, {'value': '31.7', 'groupId': 'OG001'}, {'value': '74.9', 'groupId': 'OG002'}, {'value': '65.1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After 40 weeks treatment', 'description': "Percentage of subjects who achieved (yes/no) HbA1c reduction ≥1% and weight loss ≥3% 40 weeks of treatment. Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.", 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on FAS. Number of participants analysed=number of participants with available data for HbA1c and body weight.'}, {'type': 'SECONDARY', 'title': 'Number of Treatment Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '299', 'groupId': 'OG002'}, {'value': '299', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 0.5 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).'}, {'id': 'OG001', 'title': 'Semaglutide 1.0 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'OG002', 'title': 'Dulaglutide 0.75 mg', 'description': 'Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'OG003', 'title': 'Dulaglutide 1.5 mg', 'description': 'Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '966', 'groupId': 'OG000'}, {'value': '1015', 'groupId': 'OG001'}, {'value': '802', 'groupId': 'OG002'}, {'value': '957', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '40 weeks + follow-up of 5 weeks', 'description': "A TEAE was defined as an AE with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected until the follow-up (5 weeks after the last treatment including a visit window of +7 days).", 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on the safety analysis set which included all randomised subjects exposed to at least one dose of trial product.'}, {'type': 'SECONDARY', 'title': 'Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemia Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '299', 'groupId': 'OG002'}, {'value': '299', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 0.5 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).'}, {'id': 'OG001', 'title': 'Semaglutide 1.0 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'OG002', 'title': 'Dulaglutide 0.75 mg', 'description': 'Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'OG003', 'title': 'Dulaglutide 1.5 mg', 'description': 'Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '40 weeks + follow-up of 5 weeks', 'description': "A treatment emergent hypoglycaemic episode was defined as an episode with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected until the follow-up (5 weeks after the last treatment including a visit window of +7 days). Severe or BG-confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the American Diabetes Association classification or BG-confirmed by a plasma glucose value \\<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.", 'unitOfMeasure': 'hypoglycaemic episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on the safety analysis set which included all randomised subjects exposed to at least one dose of trial product.'}, {'type': 'SECONDARY', 'title': 'Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '299', 'groupId': 'OG002'}, {'value': '299', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 0.5 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).'}, {'id': 'OG001', 'title': 'Semaglutide 1.0 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'OG002', 'title': 'Dulaglutide 0.75 mg', 'description': 'Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'OG003', 'title': 'Dulaglutide 1.5 mg', 'description': 'Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}, {'value': '1.0', 'groupId': 'OG002'}, {'value': '1.7', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '40 weeks + follow-up of 5 weeks', 'description': "Percentage of subjects with treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes. A treatment emergent hypoglycaemic episode was defined as an episode with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected until the follow-up (5 weeks after the last treatment including a visit window of +7 days). Severe or BG-confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the American Diabetes Association classification or BG-confirmed by a plasma glucose value \\<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.", 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on the safety analysis set which included all randomised subjects exposed to at least one dose of trial product.'}, {'type': 'SECONDARY', 'title': 'Change in Amylase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '296', 'groupId': 'OG001'}, {'value': '292', 'groupId': 'OG002'}, {'value': '294', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 0.5 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).'}, {'id': 'OG001', 'title': 'Semaglutide 1.0 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'OG002', 'title': 'Dulaglutide 0.75 mg', 'description': 'Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'OG003', 'title': 'Dulaglutide 1.5 mg', 'description': 'Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.17', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '1.22', 'spread': '0.02', 'groupId': 'OG001'}, {'value': '1.16', 'spread': '0.02', 'groupId': 'OG002'}, {'value': '1.20', 'spread': '0.02', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_LEAST_SQUARES_MEAN', 'timeFrame': 'Week 0, week 40', 'description': "Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value.", 'unitOfMeasure': 'ratio to baseline', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on safety analysis set. Number of participants analysed=number of participants with available data for amylase.'}, {'type': 'SECONDARY', 'title': 'Change in Lipase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '296', 'groupId': 'OG001'}, {'value': '291', 'groupId': 'OG002'}, {'value': '293', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 0.5 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).'}, {'id': 'OG001', 'title': 'Semaglutide 1.0 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'OG002', 'title': 'Dulaglutide 0.75 mg', 'description': 'Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'OG003', 'title': 'Dulaglutide 1.5 mg', 'description': 'Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.22', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '1.32', 'spread': '0.04', 'groupId': 'OG001'}, {'value': '1.23', 'spread': '0.04', 'groupId': 'OG002'}, {'value': '1.29', 'spread': '0.04', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_LEAST_SQUARES_MEAN', 'timeFrame': 'Week 0, week 40', 'description': "Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value.", 'unitOfMeasure': 'ratio to baseline', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on safety analysis set. Number of participants analysed=number of participants with available data for lipase.'}, {'type': 'SECONDARY', 'title': 'Change in Pulse Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '299', 'groupId': 'OG002'}, {'value': '299', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 0.5 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).'}, {'id': 'OG001', 'title': 'Semaglutide 1.0 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'OG002', 'title': 'Dulaglutide 0.75 mg', 'description': 'Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'OG003', 'title': 'Dulaglutide 1.5 mg', 'description': 'Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.09', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '3.96', 'spread': '0.51', 'groupId': 'OG001'}, {'value': '1.56', 'spread': '0.49', 'groupId': 'OG002'}, {'value': '2.42', 'spread': '0.50', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 0, week 40', 'description': "Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.", 'unitOfMeasure': 'beats/min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on safety analysis set.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Semaglutide 0.5 mg', 'description': 'Subjects received subcutaneous (s.c., under the skin) injections of semaglutide once weekly (OW) for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).'}, {'id': 'FG001', 'title': 'Semaglutide 1.0 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (week 1 to 4) followed by 0.5 mg for another 4 weeks (week 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (week 9-40). Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'FG002', 'title': 'Dulaglutide 0.75 mg', 'description': 'Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'FG003', 'title': 'Dulaglutide 1.5 mg', 'description': 'Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '301'}, {'groupId': 'FG001', 'numSubjects': '300'}, {'groupId': 'FG002', 'numSubjects': '300'}, {'groupId': 'FG003', 'numSubjects': '300'}]}, {'type': 'Exposed', 'achievements': [{'groupId': 'FG000', 'numSubjects': '301'}, {'groupId': 'FG001', 'numSubjects': '300'}, {'groupId': 'FG002', 'numSubjects': '299'}, {'groupId': 'FG003', 'numSubjects': '299'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '279'}, {'groupId': 'FG001', 'numSubjects': '279'}, {'groupId': 'FG002', 'numSubjects': '287'}, {'groupId': 'FG003', 'numSubjects': '284'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'Missing follow-up information', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 210 sites were approved for recruiting subjects, of which 196 sites randomized the subjects: Bulgaria: 6; Croatia: 6; Finland: 6; Germany: 6; Greece: 8; Hong Kong: 1; India: 22; Ireland: 5; Latvia: 3; Lithuania: 5; Portugal: 4; Romania: 7; Slovakia: 6; Spain: 8; United Kingdom: 8; United States: 95.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'BG000'}, {'value': '300', 'groupId': 'BG001'}, {'value': '299', 'groupId': 'BG002'}, {'value': '299', 'groupId': 'BG003'}, {'value': '1199', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Semaglutide 0.5 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).'}, {'id': 'BG001', 'title': 'Semaglutide 1.0 mg', 'description': 'Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'BG002', 'title': 'Dulaglutide 0.75 mg', 'description': 'Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'BG003', 'title': 'Dulaglutide 1.5 mg', 'description': 'Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'BG000'}, {'value': '300', 'groupId': 'BG001'}, {'value': '299', 'groupId': 'BG002'}, {'value': '299', 'groupId': 'BG003'}, {'value': '1199', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '56', 'spread': '10.9', 'groupId': 'BG000'}, {'value': '55', 'spread': '10.6', 'groupId': 'BG001'}, {'value': '55', 'spread': '10.4', 'groupId': 'BG002'}, {'value': '56', 'spread': '10.6', 'groupId': 'BG003'}, {'value': '56', 'spread': '10.6', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'BG000'}, {'value': '300', 'groupId': 'BG001'}, {'value': '299', 'groupId': 'BG002'}, {'value': '299', 'groupId': 'BG003'}, {'value': '1199', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '169', 'groupId': 'BG000'}, {'value': '162', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}, {'value': '171', 'groupId': 'BG003'}, {'value': '662', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '132', 'groupId': 'BG000'}, {'value': '138', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}, {'value': '128', 'groupId': 'BG003'}, {'value': '537', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'BG000'}, {'value': '300', 'groupId': 'BG001'}, {'value': '299', 'groupId': 'BG002'}, {'value': '299', 'groupId': 'BG003'}, {'value': '1199', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}, {'value': '138', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '272', 'groupId': 'BG000'}, {'value': '265', 'groupId': 'BG001'}, {'value': '268', 'groupId': 'BG002'}, {'value': '256', 'groupId': 'BG003'}, {'value': '1061', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'BG000'}, {'value': '300', 'groupId': 'BG001'}, {'value': '299', 'groupId': 'BG002'}, {'value': '299', 'groupId': 'BG003'}, {'value': '1199', 'groupId': 'BG004'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}, {'value': '191', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '70', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '233', 'groupId': 'BG000'}, {'value': '243', 'groupId': 'BG001'}, {'value': '232', 'groupId': 'BG002'}, {'value': '220', 'groupId': 'BG003'}, {'value': '928', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Glycosylated haemoglobin (Hb1Ac)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'BG000'}, {'value': '300', 'groupId': 'BG001'}, {'value': '299', 'groupId': 'BG002'}, {'value': '299', 'groupId': 'BG003'}, {'value': '1199', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '8.3', 'spread': '0.96', 'groupId': 'BG000'}, {'value': '8.2', 'spread': '0.92', 'groupId': 'BG001'}, {'value': '8.2', 'spread': '0.91', 'groupId': 'BG002'}, {'value': '8.2', 'spread': '0.89', 'groupId': 'BG003'}, {'value': '8.2', 'spread': '0.92', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage of HbA1c', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'BG000'}, {'value': '300', 'groupId': 'BG001'}, {'value': '299', 'groupId': 'BG002'}, {'value': '299', 'groupId': 'BG003'}, {'value': '1199', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '96.4', 'spread': '24.38', 'groupId': 'BG000'}, {'value': '95.5', 'spread': '20.90', 'groupId': 'BG001'}, {'value': '95.6', 'spread': '23.01', 'groupId': 'BG002'}, {'value': '93.4', 'spread': '21.79', 'groupId': 'BG003'}, {'value': '95.2', 'spread': '22.56', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting plasma glucose', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'BG000'}, {'value': '299', 'groupId': 'BG001'}, {'value': '297', 'groupId': 'BG002'}, {'value': '297', 'groupId': 'BG003'}, {'value': '1191', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '9.8', 'spread': '2.54', 'groupId': 'BG000'}, {'value': '9.8', 'spread': '2.58', 'groupId': 'BG001'}, {'value': '9.7', 'spread': '2.65', 'groupId': 'BG002'}, {'value': '9.6', 'spread': '2.29', 'groupId': 'BG003'}, {'value': '9.7', 'spread': '2.52', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Number of subjects analysed=subjects with available data of fasting plasma glucose at baseline'}], 'populationDescription': 'Full analysis set (FAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the FAS would contribute to the evaluation "as randomised".'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-11-30', 'size': 17020578, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-04-09T07:17', 'hasProtocol': True}, {'date': '2017-11-30', 'size': 6023501, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-04-09T07:17', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1201}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2017-05-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-02', 'studyFirstSubmitDate': '2016-01-05', 'resultsFirstSubmitDate': '2018-04-09', 'studyFirstSubmitQcDate': '2016-01-05', 'lastUpdatePostDateStruct': {'date': '2019-10-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-04-09', 'studyFirstPostDateStruct': {'date': '2016-01-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1c', 'timeFrame': 'Week 0, week 40', 'description': "Results are based on HbA1c data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on-treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit."}], 'secondaryOutcomes': [{'measure': 'Change in Body Weight (kg)', 'timeFrame': 'Week 0, week 40', 'description': "Results are based on body weight data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication."}, {'measure': 'Change in Fasting Plasma Glucose', 'timeFrame': 'Week 0, week 40', 'description': "Results are based on fasting plasma glucose data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication."}, {'measure': 'Change in Systolic and Diastolic Blood Pressure', 'timeFrame': 'Week 0, week 40', 'description': "Results are based on systolic and diastolic blood pressure data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication."}, {'measure': 'Change in Overall Scores for Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire', 'timeFrame': 'Week 0, week 40', 'description': "The questionnaire contains 8 items and evaluates subjects' diabetes treatment in terms of convenience, flexibility and general feelings towards treatment. The result presented is 'Treatment Satisfaction' summary score (sum of 6 of the 8 items). Response options: 6 (best case) to 0 (worst case). Total scores range: 0-36. Higher scores=higher satisfaction. Results are based on data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This includes observations recorded at, or after the date of first dose of trial product and not after first occurrence of following: the end-date of the 'on-treatment' observation period or initiation of rescue medication"}, {'measure': 'HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists Target', 'timeFrame': 'After 40 weeks treatment', 'description': "Percentage of subjects who achieved HbA1c target below or equal to 6.5% (48 mmol/mol) after 40 weeks of treatment. Results are based on data from on-treatment without rescue medication period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit."}, {'measure': 'Change From Baseline in 7-point Self-measured Plasma Glucose (SMPG) Mean Profile', 'timeFrame': 'Week 0, week 40', 'description': "SMPG values were recorded at 7 time-points: before and 90 minutes after start of breakfast, lunch, and dinner, and at bedtime. Reported results are mean profile from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit."}, {'measure': 'Change From Baseline 7-point Self-measured Plasma Glucose Increment', 'timeFrame': 'Week 0, week 40', 'description': "SMPG values were recorded at 7 time-points: before and 90 minutes after start of breakfast, lunch, and dinner, and at bedtime. Reported results are plasma glucose incremental profile from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes observations recorded at, or after date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit"}, {'measure': 'Change in Fasting Blood Lipids (Total Cholesterol)', 'timeFrame': 'Week 0, week 40', 'description': "Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value."}, {'measure': 'Change in Fasting Blood Lipids (Low Density Lipoprotein [LDL] Cholesterol)', 'timeFrame': 'Week 0, week 40', 'description': "Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value."}, {'measure': 'Change in Fasting Blood Lipids (High Density Lipoprotein [HDL] Cholesterol)', 'timeFrame': 'Week 0, week 40', 'description': "Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value."}, {'measure': 'Change in Fasting Blood Lipids (Triglycerides)', 'timeFrame': 'Week 0, week 40', 'description': "Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value."}, {'measure': 'Change in Body Mass Index (BMI)', 'timeFrame': 'Week 0, week 40', 'description': "Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit."}, {'measure': 'Change in Waist Circumference', 'timeFrame': 'Week 0, week 40', 'description': "Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit."}, {'measure': 'Change in Short Form Health Survey (SF-36v2™)', 'timeFrame': 'Week 0, week 40', 'description': "The questionnaire contains 36 items across 8 domains and 2 summary scores. Score range: 0 (worst score) to 100 (best score). Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit."}, {'measure': 'Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c <7.0% (53 mmol/Mol) American Diabetes Association (ADA) Target', 'timeFrame': 'After 40 weeks of treatment', 'description': "Percentage of subjects who achieved HbA1c target below or equal to \\<7.0% (53 mmol/mol) after 40 weeks of treatment. Results are based on data from on-treatment without rescue medication period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit."}, {'measure': 'Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥5%', 'timeFrame': 'After 40 weeks treatment', 'description': "Percentage of subjects who achieved weight loss ≥5% after 40 weeks of treatment. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit."}, {'measure': 'Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥10%', 'timeFrame': 'After 40 weeks treatment', 'description': "Percentage of subjects who achieved weight loss ≥10% after 40 weeks of treatment. Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit."}, {'measure': 'Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c <7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain', 'timeFrame': 'After 40 weeks of treatment', 'description': "Percentage of subjects achieved (yes/no) HbA1c \\<7.0% (53 mmol/mol) without severe or BG confirmed symptomatic hypoglycaemia episodes and no weight gain after 40 weeks of treatment. Results are based on data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was subset of 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit"}, {'measure': 'Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c Reduction ≥1%', 'timeFrame': 'After 40 weeks of treatment', 'description': "Percentage of subjects who achieved (yes/no) HbA1c reduction of ≥1% after 40 weeks of treatment. Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit."}, {'measure': 'Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥3%', 'timeFrame': 'After 40 weeks treatment', 'description': "Percentage of subjects who achieved (yes/no) weight loss of ≥3% after 40 weeks of treatment. Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit."}, {'measure': 'Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c Reduction ≥1% and Weight Loss ≥3%', 'timeFrame': 'After 40 weeks treatment', 'description': "Percentage of subjects who achieved (yes/no) HbA1c reduction ≥1% and weight loss ≥3% 40 weeks of treatment. Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit."}, {'measure': 'Number of Treatment Emergent Adverse Events (TEAEs)', 'timeFrame': '40 weeks + follow-up of 5 weeks', 'description': "A TEAE was defined as an AE with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected until the follow-up (5 weeks after the last treatment including a visit window of +7 days)."}, {'measure': 'Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemia Episodes', 'timeFrame': '40 weeks + follow-up of 5 weeks', 'description': "A treatment emergent hypoglycaemic episode was defined as an episode with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected until the follow-up (5 weeks after the last treatment including a visit window of +7 days). Severe or BG-confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the American Diabetes Association classification or BG-confirmed by a plasma glucose value \\<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia."}, {'measure': 'Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes', 'timeFrame': '40 weeks + follow-up of 5 weeks', 'description': "Percentage of subjects with treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes. A treatment emergent hypoglycaemic episode was defined as an episode with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected until the follow-up (5 weeks after the last treatment including a visit window of +7 days). Severe or BG-confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the American Diabetes Association classification or BG-confirmed by a plasma glucose value \\<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia."}, {'measure': 'Change in Amylase', 'timeFrame': 'Week 0, week 40', 'description': "Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value."}, {'measure': 'Change in Lipase', 'timeFrame': 'Week 0, week 40', 'description': "Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value."}, {'measure': 'Change in Pulse Rate', 'timeFrame': 'Week 0, week 40', 'description': "Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '30865526', 'type': 'BACKGROUND', 'citation': 'Rodbard HW, Bellary S, Hramiak I, Seino Y, Silver R, Damgaard LH, Nayak G, Zacho J, Aroda VR. GREATER COMBINED REDUCTIONS IN HbA1C >/=1.0% AND WEIGHT >/=5.0% WITH SEMAGLUTIDE VERSUS COMPARATORS IN TYPE 2 DIABETES. Endocr Pract. 2019 Jun;25(6):589-597. doi: 10.4158/EP-2018-0444. Epub 2019 Mar 13.'}, {'pmid': '30927241', 'type': 'BACKGROUND', 'citation': 'Johansen P, Hakan-Bloch J, Liu AR, Bech PG, Persson S, Leiter LA. Cost Effectiveness of Once-Weekly Semaglutide Versus Once-Weekly Dulaglutide in the Treatment of Type 2 Diabetes in Canada. Pharmacoecon Open. 2019 Dec;3(4):537-550. doi: 10.1007/s41669-019-0131-6.'}, {'pmid': '31168765', 'type': 'BACKGROUND', 'citation': 'Malkin SJP, Russel-Szymczyk M, Psota M, Hlavinkova L, Hunt B. The Management of Type 2 Diabetes with Once-Weekly Semaglutide Versus Dulaglutide: A Long-Term Cost-Effectiveness Analysis in Slovakia. Adv Ther. 2019 Aug;36(8):2034-2051. doi: 10.1007/s12325-019-00965-y. Epub 2019 Jun 5.'}, {'pmid': '29397376', 'type': 'RESULT', 'citation': 'Pratley RE, Aroda VR, Lingvay I, Ludemann J, Andreassen C, Navarria A, Viljoen A; SUSTAIN 7 investigators. Semaglutide versus dulaglutide once weekly in patients with type 2 diabetes (SUSTAIN 7): a randomised, open-label, phase 3b trial. Lancet Diabetes Endocrinol. 2018 Apr;6(4):275-286. doi: 10.1016/S2213-8587(18)30024-X. Epub 2018 Feb 1.'}, {'pmid': '29246950', 'type': 'RESULT', 'citation': 'Ahmann AJ, Capehorn M, Charpentier G, Dotta F, Henkel E, Lingvay I, Holst AG, Annett MP, Aroda VR. Efficacy and Safety of Once-Weekly Semaglutide Versus Exenatide ER in Subjects With Type 2 Diabetes (SUSTAIN 3): A 56-Week, Open-Label, Randomized Clinical Trial. Diabetes Care. 2018 Feb;41(2):258-266. doi: 10.2337/dc17-0417. Epub 2017 Dec 15.'}, {'pmid': '29764222', 'type': 'RESULT', 'citation': 'Sharma R, Wilkinson L, Vrazic H, Popoff E, Lopes S, Kanters S, Druyts E. Comparative efficacy of once-weekly semaglutide and SGLT-2 inhibitors in type 2 diabetic patients inadequately controlled with metformin monotherapy: a systematic literature review and network meta-analysis. Curr Med Res Opin. 2018 Sep;34(9):1595-1603. doi: 10.1080/03007995.2018.1476332. Epub 2018 May 29.'}, {'pmid': '29557057', 'type': 'RESULT', 'citation': 'Wilkinson L, Hunt B, Johansen P, Iyer NN, Dang-Tan T, Pollock RF. Cost of Achieving HbA1c Treatment Targets and Weight Loss Responses with Once-Weekly Semaglutide Versus Dulaglutide in the United States. Diabetes Ther. 2018 Jun;9(3):951-961. doi: 10.1007/s13300-018-0402-8. Epub 2018 Mar 19.'}, {'pmid': '30615985', 'type': 'RESULT', 'citation': 'Aroda VR, Ahmann A, Cariou B, Chow F, Davies MJ, Jodar E, Mehta R, Woo V, Lingvay I. Comparative efficacy, safety, and cardiovascular outcomes with once-weekly subcutaneous semaglutide in the treatment of type 2 diabetes: Insights from the SUSTAIN 1-7 trials. Diabetes Metab. 2019 Oct;45(5):409-418. doi: 10.1016/j.diabet.2018.12.001. Epub 2019 Jan 4.'}, {'pmid': '30362224', 'type': 'RESULT', 'citation': 'Viljoen A, Hoxer CS, Johansen P, Malkin S, Hunt B, Bain SC. Evaluation of the long-term cost-effectiveness of once-weekly semaglutide versus dulaglutide for treatment of type 2 diabetes mellitus in the UK. Diabetes Obes Metab. 2019 Mar;21(3):611-621. doi: 10.1111/dom.13564. Epub 2018 Nov 28.'}, {'pmid': '38777128', 'type': 'DERIVED', 'citation': 'Osumili B, Fan L, Paik JS, Pantalone KM, Ranta K, Sapin H, Tofe S. Tirzepatide 5, 10 and 15 mg versus injectable semaglutide 0.5 mg for the treatment of type 2 diabetes: An adjusted indirect treatment comparison. Diabetes Res Clin Pract. 2024 Jun;212:111717. doi: 10.1016/j.diabres.2024.111717. Epub 2024 May 21.'}, {'pmid': '33199417', 'type': 'DERIVED', 'citation': 'Pratley RE, Aroda VR, Catarig AM, Lingvay I, Ludemann J, Yildirim E, Viljoen A. Impact of patient characteristics on efficacy and safety of once-weekly semaglutide versus dulaglutide: SUSTAIN 7 post hoc analyses. BMJ Open. 2020 Nov 16;10(11):e037883. doi: 10.1136/bmjopen-2020-037883.'}, {'pmid': '31769496', 'type': 'DERIVED', 'citation': 'DeSouza C, Cariou B, Garg S, Lausvig N, Navarria A, Fonseca V. Efficacy and Safety of Semaglutide for Type 2 Diabetes by Race and Ethnicity: A Post Hoc Analysis of the SUSTAIN Trials. J Clin Endocrinol Metab. 2020 Feb 1;105(2):dgz072. doi: 10.1210/clinem/dgz072.'}, {'pmid': '31215727', 'type': 'DERIVED', 'citation': 'Jendle J, Birkenfeld AL, Polonsky WH, Silver R, Uusinarkaus K, Hansen T, Hakan-Bloch J, Tadayon S, Davies MJ. Improved treatment satisfaction in patients with type 2 diabetes treated with once-weekly semaglutide in the SUSTAIN trials. Diabetes Obes Metab. 2019 Oct;21(10):2315-2326. doi: 10.1111/dom.13816. Epub 2019 Jul 12.'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Asia, Europe and the United States of America (USA). The aim of the trial is to investigate efficacy and safety of semaglutide versus dulaglutide as add-on to metformin in subjects with type 2 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria: - Male or female, age at least 18 years at the time of signing informed consent. - HbA1c (glycosylated haemoglobin) 7.0 - 10.5% (53 - 91 mmol/mol) (both inclusive) - Subjects on stable diabetes treatment with metformin (minimum of 1500 mg/day or maximal tolerated dose documented in the patient medical record) for 90 days prior to screening Exclusion Criteria: - Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice) - Any condition, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol - Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening. An exception is short-term insulin treatment for acute illness for a total of equal to or below 14 days - History of pancreatitis (acute or chronic) - Screening calcitonin equal to or above 50 ng/L - Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma - Renal impairment defined as eGFR (electronic case report form) below 60 mL/min/1.73 m\\^2 as per CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) - Subjects presently classified as being in New York Heart Association Class IV - Planned coronary, carotid or peripheral artery revascularisation on the day of screening - Proliferative retinopathy or maculopathy requiring acute treatment - History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinomas) - 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': 'NCT02648204', 'acronym': 'SUSTAIN 7', 'briefTitle': 'Efficacy and Safety of Semaglutide Versus Dulaglutide as add-on to Metformin in Subjects With Type 2 Diabetes.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Efficacy and Safety of Semaglutide Versus Dulaglutide as add-on to Metformin in Subjects With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'NN9535-4216'}, 'secondaryIdInfos': [{'id': '2014-005375-91', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1164-8495', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Semaglutide 0.5 mg/Week', 'interventionNames': ['Drug: semaglutide']}, {'type': 'EXPERIMENTAL', 'label': 'Semaglutide 1.0 mg/Week', 'interventionNames': ['Drug: semaglutide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dulaglutide 0.75 mg/Week', 'interventionNames': ['Drug: Dulaglutide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dulaglutide 1.5 mg/Week', 'interventionNames': ['Drug: Dulaglutide']}], 'interventions': [{'name': 'semaglutide', 'type': 'DRUG', 'description': 'Administered subcutaneously (s.c., under the skin) once-weekly.', 'armGroupLabels': ['Semaglutide 0.5 mg/Week', 'Semaglutide 1.0 mg/Week']}, {'name': 'Dulaglutide', 'type': 'DRUG', 'description': 'Administered subcutaneously (s.c., under the skin) once-weekly.', 'armGroupLabels': ['Dulaglutide 0.75 mg/Week', 'Dulaglutide 1.5 mg/Week']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35674', 'city': 'Tuscumbia', 'state': 'Alabama', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 34.7312, 'lon': -87.70253}}, {'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 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