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Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-24 @ 5:03 PM

Ignite Modification Date: 2026-02-27 @ 4:41 AM

Study NCT ID: NCT03235050

Status: COMPLETED

Last Update Posted: 2020-08-17

First Post: 2017-07-21

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: A Study to Evaluate the Efficacy and Safety of MEDI0382 in the Treatment of Overweight and Obese Subjects With Type 2 Diabetes

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Hungary'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-06-22', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000624433', 'term': 'cotadutide'}, {'id': 'D000069450', 'term': 'Liraglutide'}], 'ancestors': [{'id': 'D052216', 'term': 'Glucagon-Like Peptide 1'}, {'id': 'D004763', 'term': 'Glucagon-Like Peptides'}, {'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D005768', 'term': 'Gastrointestinal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'information.center@astrazeneca.com', 'phone': '1-877-240-9479', 'title': 'AstraZenenca Information Center', 'organization': 'AstraZeneca'}, 'certainAgreement': {'otherDetails': 'The Principal Investigator shall provide AstraZeneca with copies of any materials relating to the Study, the Study Documentation, or the Developed Technologies that either Party intends to publish (or submit for publication) or make any presentations relating to, at least 60 days in advance of publication, submission or presentation.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from time of first IP dose throughout the 54-week treatment period and including the 28-day follow-up period. Serious AEs were recorded from the time of signature of informed consent.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)', 'otherNumAtRisk': 112, 'deathsNumAtRisk': 112, 'otherNumAffected': 45, 'seriousNumAtRisk': 112, 'deathsNumAffected': 0, 'seriousNumAffected': 12}, {'id': 'EG001', 'title': 'Liraglutide', 'description': 'Liraglutide + Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)', 'otherNumAtRisk': 110, 'deathsNumAtRisk': 110, 'otherNumAffected': 36, 'seriousNumAtRisk': 110, 'deathsNumAffected': 0, 'seriousNumAffected': 8}, {'id': 'EG002', 'title': 'MEDI0382 100 mcg', 'description': 'MEDI0382 low dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)', 'otherNumAtRisk': 100, 'deathsNumAtRisk': 100, 'otherNumAffected': 51, 'seriousNumAtRisk': 100, 'deathsNumAffected': 0, 'seriousNumAffected': 12}, {'id': 'EG003', 'title': 'MEDI0382 200 mcg', 'description': 'MEDI0382 mid dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)', 'otherNumAtRisk': 256, 'deathsNumAtRisk': 256, 'otherNumAffected': 159, 'seriousNumAtRisk': 256, 'deathsNumAffected': 2, 'seriousNumAffected': 33}, {'id': 'EG004', 'title': 'MEDI0382 300 mcg', 'description': 'MEDI0382 high dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)', 'otherNumAtRisk': 256, 'deathsNumAtRisk': 256, 'otherNumAffected': 164, 'seriousNumAtRisk': 256, 'deathsNumAffected': 1, 'seriousNumAffected': 20}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 256, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 256, 'numEvents': 14, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 256, 'numEvents': 68, 'numAffected': 49}, {'groupId': 'EG004', 'numAtRisk': 256, 'numEvents': 40, 'numAffected': 28}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 13, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 256, 'numEvents': 26, 'numAffected': 19}, {'groupId': 'EG004', 'numAtRisk': 256, 'numEvents': 38, 'numAffected': 28}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Eructation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 256, 'numEvents': 17, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 256, 'numEvents': 15, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 21, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 28, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 256, 'numEvents': 115, 'numAffected': 85}, {'groupId': 'EG004', 'numAtRisk': 256, 'numEvents': 143, 'numAffected': 105}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 256, 'numEvents': 66, 'numAffected': 51}, {'groupId': 'EG004', 'numAtRisk': 256, 'numEvents': 58, 'numAffected': 43}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 19, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 256, 'numEvents': 28, 'numAffected': 22}, {'groupId': 'EG004', 'numAtRisk': 256, 'numEvents': 44, 'numAffected': 28}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 256, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 256, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 256, 'numEvents': 17, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 256, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 256, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 256, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 256, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 256, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 256, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 256, 'numEvents': 19, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 256, 'numEvents': 18, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 256, 'numEvents': 23, 'numAffected': 19}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 256, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 256, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 256, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 256, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 256, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Aortic valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 256, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 256, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 256, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 256, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 256, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 256, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 256, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 256, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 256, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Silent myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Retinal tear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 256, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 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'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 256, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 256, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Hiatus hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 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'OG002', 'title': 'MEDI0382 200 mcg', 'description': 'MEDI0382 mid dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)'}, {'id': 'OG003', 'title': 'MEDI0382 300 mcg', 'description': 'MEDI0382 high dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.70', 'groupId': 'OG000', 'lowerLimit': '-1.44', 'upperLimit': '0.04'}, {'value': '-2.70', 'groupId': 'OG001', 'lowerLimit': '-3.49', 'upperLimit': '-1.91'}, {'value': '-3.47', 'groupId': 'OG002', 'lowerLimit': '-3.95', 'upperLimit': '-2.98'}, {'value': '-4.33', 'groupId': 'OG003', 'lowerLimit': '-4.82', 'upperLimit': '-3.84'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.00', 'ciLowerLimit': '-3.08', 'ciUpperLimit': '-0.91', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.76', 'ciLowerLimit': '-3.65', 'ciUpperLimit': '-1.87', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.62', 'ciLowerLimit': '-4.51', 'ciUpperLimit': '-2.73', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From baseline to 14 weeks', 'description': 'To assess the effect of 100, 200, 300 μg of cotadutide on body weight versus placebo', 'unitOfMeasure': 'percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Change in HbA1c', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '256', 'groupId': 'OG002'}, {'value': '256', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)'}, {'id': 'OG001', 'title': 'MEDI0382 100 mcg', 'description': 'MEDI0382 low dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)'}, {'id': 'OG002', 'title': 'MEDI0382 200 mcg', 'description': 'MEDI0382 mid dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)'}, {'id': 'OG003', 'title': 'MEDI0382 300 mcg', 'description': 'MEDI0382 high dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)'}], 'classes': [{'title': 'from baseline to 26 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '252', 'groupId': 'OG002'}, {'value': '252', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.40', 'groupId': 'OG000', 'lowerLimit': '-0.58', 'upperLimit': '-0.22'}, {'value': '-1.06', 'groupId': 'OG001', 'lowerLimit': '-1.25', 'upperLimit': '-0.87'}, {'value': '-1.22', 'groupId': 'OG002', 'lowerLimit': '-1.34', 'upperLimit': '-1.10'}, {'value': '-1.12', 'groupId': 'OG003', 'lowerLimit': '-1.24', 'upperLimit': '-1.00'}]}]}, {'title': 'from baseline to 54 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '252', 'groupId': 'OG002'}, {'value': '252', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.44', 'groupId': 'OG000', 'lowerLimit': '-0.63', 'upperLimit': '-0.24'}, {'value': '-0.96', 'groupId': 'OG001', 'lowerLimit': '-1.16', 'upperLimit': '-0.75'}, {'value': '-1.06', 'groupId': 'OG002', 'lowerLimit': '-1.19', 'upperLimit': '-0.93'}, {'value': '-1.01', 'groupId': 'OG003', 'lowerLimit': '-1.14', 'upperLimit': '-0.88'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.66', 'ciLowerLimit': '-0.92', 'ciUpperLimit': '-0.40', 'groupDescription': 'Week 26', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.81', 'ciLowerLimit': '-1.03', 'ciUpperLimit': '-0.60', 'groupDescription': 'Week 26', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.72', 'ciLowerLimit': '-0.94', 'ciUpperLimit': '-0.51', 'groupDescription': 'Week 26', 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'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'from baseline to 26 weeks and 54 weeks', 'description': 'To assess the effect of 100, 200, 300 μg of cotadutide on HbA1c versus placebo', 'unitOfMeasure': 'percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving an HbA1c Target < 7.0%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '256', 'groupId': 'OG002'}, {'value': '256', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)'}, {'id': 'OG001', 'title': 'MEDI0382 100 mcg', 'description': 'MEDI0382 low dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)'}, {'id': 'OG002', 'title': 'MEDI0382 200 mcg', 'description': 'MEDI0382 mid dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)'}, {'id': 'OG003', 'title': 'MEDI0382 300 mcg', 'description': 'MEDI0382 high dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)'}], 'classes': [{'title': 'after 14 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '252', 'groupId': 'OG002'}, {'value': '252', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}, {'value': '143', 'groupId': 'OG003'}]}]}, {'title': 'after 26 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '252', 'groupId': 'OG002'}, {'value': '252', 'groupId': 'OG003'}]}], 'categories': 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26', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.012', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.09', 'ciLowerLimit': '1.75', 'ciUpperLimit': '97.68', 'groupDescription': 'weight loss \\>=10% at Week 26', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.013', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.92', 'ciLowerLimit': '1.49', 'ciUpperLimit': '32.07', 'groupDescription': 'weight loss \\>=10% at Week 54', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.032', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.98', 'ciLowerLimit': '1.15', 'ciUpperLimit': '21.60', 'groupDescription': 'weight loss \\>=10% at Week 54', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.005', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.91', 'ciLowerLimit': '1.86', 'ciUpperLimit': '33.64', 'groupDescription': 'weight loss \\>=10% at Week 54', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'after 14 weeks, 26 weeks and 54 weeks', 'description': 'To assess the effect of 100, 200, and 300 μg of cotadutide on percentage of subjects achieving weight loss of ≥5% and ≥10% versus placebo', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Rescued or Discontinued for Lack of Glycaemic Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '256', 'groupId': 'OG002'}, {'value': '256', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)'}, {'id': 'OG001', 'title': 'MEDI0382 100 mcg', 'description': 'MEDI0382 low dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)'}, {'id': 'OG002', 'title': 'MEDI0382 200 mcg', 'description': 'MEDI0382 mid dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)'}, {'id': 'OG003', 'title': 'MEDI0382 300 mcg', 'description': 'MEDI0382 high dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)'}], 'classes': [{'title': 'received rescue medication at 14 wks', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'received rescue medication at 26 wks', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'received rescue medication at 54 wks', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}]}, {'title': 'discontinued study IP at 14 wks', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'discontinued study IP at 26 wks', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'discontinued study IP at 54 wks', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.024', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.09', 'ciLowerLimit': '0.01', 'ciUpperLimit': '0.73', 'groupDescription': 'received rescue medication at 14 wks', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.11', 'ciLowerLimit': '0.03', 'ciUpperLimit': '0.40', 'groupDescription': 'received rescue medication at 14 wks', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.07', 'ciLowerLimit': '0.02', 'ciUpperLimit': '0.33', 'groupDescription': 'received rescue medication at 14 wks', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.14', 'ciLowerLimit': '0.04', 'ciUpperLimit': '0.48', 'groupDescription': 'received rescue medication at 26 wks', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.14', 'ciLowerLimit': '0.06', 'ciUpperLimit': '0.34', 'groupDescription': 'received rescue medication at 26 wks', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.11', 'ciLowerLimit': '0.04', 'ciUpperLimit': '0.28', 'groupDescription': 'received rescue medication at 26 wks', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.24', 'ciLowerLimit': '0.11', 'ciUpperLimit': '0.53', 'groupDescription': 'received rescue medication at 54 wks', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.24', 'ciLowerLimit': '0.13', 'ciUpperLimit': '0.44', 'groupDescription': 'received rescue medication at 54 wks', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.22', 'ciLowerLimit': '0.12', 'ciUpperLimit': '0.41', 'groupDescription': 'received rescue medication at 54 wks', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.216', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.22', 'ciLowerLimit': '0.02', 'ciUpperLimit': '2.43', 'groupDescription': 'discontinued IP at 14 wks', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.253', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.28', 'ciLowerLimit': '0.03', 'ciUpperLimit': '2.52', 'groupDescription': 'discontinued IP at 26 wks', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.079', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.21', 'ciLowerLimit': '0.04', 'ciUpperLimit': '1.19', 'groupDescription': 'discontinued IP at 26 wks', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.252', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.27', 'ciLowerLimit': '0.03', 'ciUpperLimit': '2.50', 'groupDescription': 'discontinued IP at 54 wks', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.143', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.32', 'ciLowerLimit': '0.07', 'ciUpperLimit': '1.47', 'groupDescription': 'discontinued IP at 54 wks', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at 14 weeks, 26 weeks and 54 weeks', 'description': 'To assess the effect of 100, 200, and 300 μg of cotadutide on the requirement for additional blood glucose-lowering therapies versus placebo', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetic (PK) Endpoint: Trough Plasma Concentration (Cmin)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '256', 'groupId': 'OG002'}, {'value': '256', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)'}, {'id': 'OG001', 'title': 'MEDI0382 100 mcg', 'description': 'MEDI0382 low dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)'}, {'id': 'OG002', 'title': 'MEDI0382 200 mcg', 'description': 'MEDI0382 mid dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)'}, {'id': 'OG003', 'title': 'MEDI0382 300 mcg', 'description': 'MEDI0382 high dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '179', 'groupId': 'OG002'}, {'value': '170', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.68', 'spread': '1.27', 'groupId': 'OG001'}, {'value': '2.76', 'spread': '1.88', 'groupId': 'OG002'}, {'value': '2.77', 'spread': '1.84', 'groupId': 'OG003'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '180', 'groupId': 'OG002'}, {'value': '168', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.66', 'spread': '1.61', 'groupId': 'OG001'}, {'value': '5.13', 'spread': '3.23', 'groupId': 'OG002'}, {'value': '5.18', 'spread': '3.05', 'groupId': 'OG003'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '192', 'groupId': 'OG002'}, {'value': '177', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.75', 'spread': '1.44', 'groupId': 'OG001'}, {'value': '5.20', 'spread': '3.57', 'groupId': 'OG002'}, {'value': '7.77', 'spread': '4.88', 'groupId': 'OG003'}]}]}, {'title': 'Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}, {'value': '172', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.18', 'spread': '2.26', 'groupId': 'OG001'}, {'value': '5.74', 'spread': '4.23', 'groupId': 'OG002'}, {'value': '8.23', 'spread': '4.31', 'groupId': 'OG003'}]}]}, {'title': 'Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '184', 'groupId': 'OG002'}, {'value': '178', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.79', 'spread': '4.05', 'groupId': 'OG001'}, {'value': '6.50', 'spread': '5.26', 'groupId': 'OG002'}, {'value': '9.71', 'spread': '7.64', 'groupId': 'OG003'}]}]}, {'title': 'Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '180', 'groupId': 'OG002'}, {'value': '169', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.58', 'spread': '5.04', 'groupId': 'OG001'}, {'value': '7.43', 'spread': '6.43', 'groupId': 'OG002'}, {'value': '10.8', 'spread': '7.95', 'groupId': 'OG003'}]}]}, {'title': 'Week 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '177', 'groupId': 'OG002'}, {'value': '168', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.63', 'spread': '4.28', 'groupId': 'OG001'}, {'value': '8.07', 'spread': '7.01', 'groupId': 'OG002'}, {'value': '11.5', 'spread': '9.77', 'groupId': 'OG003'}]}]}, {'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '183', 'groupId': 'OG002'}, {'value': '167', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.39', 'spread': '3.33', 'groupId': 'OG001'}, {'value': '8.12', 'spread': '7.31', 'groupId': 'OG002'}, {'value': '12.9', 'spread': '12.1', 'groupId': 'OG003'}]}]}, {'title': 'Week 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '180', 'groupId': 'OG002'}, {'value': '166', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.58', 'spread': '3.89', 'groupId': 'OG001'}, {'value': '8.99', 'spread': '9.22', 'groupId': 'OG002'}, {'value': '13.2', 'spread': '14.3', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Time points at which outcome measure were assessed for plasma concentration were Weeks 1,2,6,10,14,18,22,26, and 54', 'description': 'To characterise the PK profile of 100, 200, and 300 μg of cotadutide', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population'}, {'type': 'SECONDARY', 'title': 'Immunogenicity Endpoint: Overall Antidrug Antibody (ADA) Incidence (Number and Percentage of Positive Partipants)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '256', 'groupId': 'OG002'}, {'value': '256', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)'}, {'id': 'OG001', 'title': 'MEDI0382 100 mcg', 'description': 'MEDI0382 low dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)'}, {'id': 'OG002', 'title': 'MEDI0382 200 mcg', 'description': 'MEDI0382 mid dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)'}, {'id': 'OG003', 'title': 'MEDI0382 300 mcg', 'description': 'MEDI0382 high dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)'}], 'classes': [{'title': 'ADA positive at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '250', 'groupId': 'OG002'}, {'value': '249', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'ADA incidence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '248', 'groupId': 'OG002'}, {'value': '250', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}, {'value': '155', 'groupId': 'OG003'}]}]}, {'title': 'ADA positive post-baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '248', 'groupId': 'OG002'}, {'value': '250', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}, {'value': '155', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline through 54-week treatment period and 28-day follow-up', 'description': 'To characterise the immunogenicity of 100, 200, and 300 μg of cotadutide', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated population'}, {'type': 'SECONDARY', 'title': 'Immunogenicity Endpoint: Median Titer of the Anti-Drug Antibodies (ADA) to MEDI0382 in the Positive Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '256', 'groupId': 'OG002'}, {'value': '256', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)'}, {'id': 'OG001', 'title': 'MEDI0382 100 mcg', 'description': 'MEDI0382 low dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)'}, {'id': 'OG002', 'title': 'MEDI0382 200 mcg', 'description': 'MEDI0382 mid dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)'}, {'id': 'OG003', 'title': 'MEDI0382 300 mcg', 'description': 'MEDI0382 high dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)'}], 'classes': [{'title': 'ADA positive at baseline, median titer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '250', 'groupId': 'OG002'}, {'value': '249', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '5.0', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'ADA incidence, median of maximum titer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '248', 'groupId': 'OG002'}, {'value': '250', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '20'}, {'value': '20.0', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '2560'}, {'value': '20.0', 'groupId': 'OG002', 'lowerLimit': '5', 'upperLimit': '640'}, {'value': '20.0', 'groupId': 'OG003', 'lowerLimit': '5', 'upperLimit': '5120'}]}]}, {'title': 'ADA positive post-baseline, median of max. titer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '248', 'groupId': 'OG002'}, {'value': '250', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '20'}, {'value': '20.0', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '2560'}, {'value': '20.0', 'groupId': 'OG002', 'lowerLimit': '5', 'upperLimit': '640'}, {'value': '20.0', 'groupId': 'OG003', 'lowerLimit': '5', 'upperLimit': '5120'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline through 54-week treatment period and 28-day follow-up', 'description': 'To characterise the immunogenicity of 100, 200, and 300 μg of cotadutide', 'unitOfMeasure': 'titer', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)'}, {'id': 'FG001', 'title': 'Liraglutide', 'description': 'Liraglutide + Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)'}, {'id': 'FG002', 'title': 'MEDI0382 100 mcg', 'description': 'MEDI0382(cotadutide) low dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)'}, {'id': 'FG003', 'title': 'MEDI0382 200 mcg', 'description': 'MEDI0382(cotadutide) mid dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)'}, {'id': 'FG004', 'title': 'MEDI0382 300 mcg', 'description': 'MEDI0382(cotadutide) high dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '112'}, {'groupId': 'FG001', 'numSubjects': '110'}, {'groupId': 'FG002', 'numSubjects': '100'}, {'groupId': 'FG003', 'numSubjects': '256'}, {'groupId': 'FG004', 'numSubjects': '256'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '108'}, {'groupId': 'FG001', 'numSubjects': '105'}, {'groupId': 'FG002', 'numSubjects': '96'}, {'groupId': 'FG003', 'numSubjects': '242'}, {'groupId': 'FG004', 'numSubjects': '245'}]}, {'type': 'NOT COMPLETED', 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{'value': '252', 'groupId': 'BG004'}, {'value': '806', 'groupId': 'BG005'}]}, {'title': 'Other', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-12-04', 'size': 4109683, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-07-31T11:11', 'hasProtocol': True}, {'date': '2019-03-20', 'size': 624659, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-07-31T11:11', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'The study will be conducted in a double-blind fashion for MEDI0382 and placebo. The sponsor staff, the subjects, and the Investigators involved in the treatment of subjects or in the clinical evaluation of subjects will not be aware of the treatment received. Liraglutide will be provided in an open-label active comparator arm.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomised, parallel, double-blind, placebo-controlled study with an open-label active comparator.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 834}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'dispFirstSubmitDate': '2019-03-07', 'completionDateStruct': {'date': '2019-06-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-31', 'studyFirstSubmitDate': '2017-07-21', 'dispFirstSubmitQcDate': '2020-07-03', 'resultsFirstSubmitDate': '2020-06-03', 'studyFirstSubmitQcDate': '2017-07-27', 'dispFirstPostDateStruct': {'date': '2020-07-20', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-08-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-07-03', 'studyFirstPostDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1c', 'timeFrame': 'From baseline to 14 weeks', 'description': 'To assess the effect of 100, 200, 300 μg of cotadutide on HbA1c versus placebo'}, {'measure': 'Percent Change in Body Weight', 'timeFrame': 'From baseline to 14 weeks', 'description': 'To assess the effect of 100, 200, 300 μg of cotadutide on body weight versus placebo'}], 'secondaryOutcomes': [{'measure': 'Change in HbA1c', 'timeFrame': 'from baseline to 26 weeks and 54 weeks', 'description': 'To assess the effect of 100, 200, 300 μg of cotadutide on HbA1c versus placebo'}, {'measure': 'Percentage of Participants Achieving an HbA1c Target < 7.0%', 'timeFrame': 'after 14, 26, and 54 weeks', 'description': 'To assess the effect of 100, 200, and 300 μg of cotadutide on percentage of participants achieving an HbA1c target of \\<7% versus placebo'}, {'measure': 'Percent Change in Body Weight', 'timeFrame': 'from baseline to 26 weeks and 54 weeks', 'description': 'To assess the effect of 100, 200, and 300 μg of cotadutide on body weight versus placebo'}, {'measure': 'Absolute Change in Body Weight', 'timeFrame': 'from baseline to 14 weeks, 26 weeks and 54 weeks', 'description': 'To assess the effect of 100, 200, 300 μg of cotadutide on body weight versus placebo'}, {'measure': 'Percent Change in Body Weight Versus Active Comparator', 'timeFrame': 'from baseline to 14 weeks, 26 weeks and 54 weeks', 'description': 'To assess the effect of 100, 200, and 300 μg of cotadutide on body weight versus liraglutide 1.8 mg once daily'}, {'measure': 'Absolute Change in Body Weight Versus Active Comparator', 'timeFrame': 'from baseline to 14 weeks, 26 weeks and 54 weeks', 'description': 'To assess the effect of 100, 200, and 300 μg of cotadutide on body weight versus liraglutide 1.8 mg once daily'}, {'measure': 'Percentage of Participants Achieving Weight Loss of ≥5% and ≥10%', 'timeFrame': 'after 14 weeks, 26 weeks and 54 weeks', 'description': 'To assess the effect of 100, 200, and 300 μg of cotadutide on percentage of subjects achieving weight loss of ≥5% and ≥10% versus placebo'}, {'measure': 'Percentage of Participants Rescued or Discontinued for Lack of Glycaemic Control', 'timeFrame': 'at 14 weeks, 26 weeks and 54 weeks', 'description': 'To assess the effect of 100, 200, and 300 μg of cotadutide on the requirement for additional blood glucose-lowering therapies versus placebo'}, {'measure': 'Pharmacokinetic (PK) Endpoint: Trough Plasma Concentration (Cmin)', 'timeFrame': 'Time points at which outcome measure were assessed for plasma concentration were Weeks 1,2,6,10,14,18,22,26, and 54', 'description': 'To characterise the PK profile of 100, 200, and 300 μg of cotadutide'}, {'measure': 'Immunogenicity Endpoint: Overall Antidrug Antibody (ADA) Incidence (Number and Percentage of Positive Partipants)', 'timeFrame': 'Baseline through 54-week treatment period and 28-day follow-up', 'description': 'To characterise the immunogenicity of 100, 200, and 300 μg of cotadutide'}, {'measure': 'Immunogenicity Endpoint: Median Titer of the Anti-Drug Antibodies (ADA) to MEDI0382 in the Positive Participants', 'timeFrame': 'Baseline through 54-week treatment period and 28-day follow-up', 'description': 'To characterise the immunogenicity of 100, 200, and 300 μg of cotadutide'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '34016612', 'type': 'DERIVED', 'citation': 'Nahra R, Wang T, Gadde KM, Oscarsson J, Stumvoll M, Jermutus L, Hirshberg B, Ambery P. Effects of Cotadutide on Metabolic and Hepatic Parameters in Adults With Overweight or Obesity and Type 2 Diabetes: A 54-Week Randomized Phase 2b Study. Diabetes Care. 2021 Jun;44(6):1433-1442. doi: 10.2337/dc20-2151. Epub 2021 May 20.'}], 'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D5670C00004&attachmentIdentifier=d3772b2d-e5a9-4fef-b796-e371735f6b2d&fileName=D5670C00004_SAP_redacted.pdf&versionIdentifier=', 'label': 'D5670C00004 SAP redacted'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D5670C00004&attachmentIdentifier=e91d84a4-416d-4262-aea8-98b99f6854c5&fileName=D5670C00004_CSP_redacted.pdf&versionIdentifier=', 'label': 'D5670C00004 CSP redacted'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate the dose range for MEDI0382 with respect to blood glucose control and weight loss effects, as well as to further explore the safety profile of MEDI0382'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '130 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Provision of informed consent\n* Male and female subjects aged ≥ 18 years at screening\n* Body mass index ≥ 25 kg/m2 at screening\n* HbA1c range of 7.0% to 10.5% (inclusive) at screening\n* Diagnosed with type-2 diabetes mellitus (T2DM) and treated with metformin (stable dose of ≥1500 mg/day or maximal tolerated dose) for at least 2 months prior to screening. Use of another glucose-lowering medication for up to 2 weeks in the 2 months prior to screening is acceptable\n* Women of childbearing potential (WOCBP), not breastfeeding and using appropriate birth control to avoid pregnancy throughout the study and for up to 4 weeks after the last dose of investigational product (IP), with a negative pregnancy test within 72 hours prior to the start of IP\n\nExclusion Criteria:\n\n* History of, or any existing condition that, in the opinion of the Investigator, would interfere with evaluation of the IP, put the subject at risk, influence the subject's ability to participate or affect the interpretation of the results of the study and/or any subject unable or unwilling to follow study procedures\n* Any subject who has received another IP as part of a clinical study or a GLP-1 receptor agonist containing preparation within the last 30 days or 5 half lives of the drug (whichever is longer) at the time of screening\n* Severe allergy/hypersensitivity to any of the proposed study treatments or excipients\n* Symptoms of acutely decompensated blood glucose control, a history of type 1 diabetes mellitus or diabetic ketoacidosis, or if the subject has been treated with daily subcutaneous (SC) insulin for a period longer than 2 weeks within 90 days prior to screening\n* Acute or chronic pancreatitis. Subjects with serum triglyceride concentrations above 1000 mg/dL (11 mmol/L) at screening\n* Significant inflammatory bowel disease or other severe disease or surgery affecting the upper Gastrointestinal (GI) tract\n* Significant hepatic disease\n* Impaired renal function defined as estimated glomerular filtration rate (eGFR) ≤30 mL/minute/1.73m2 at screening\n* Severely uncontrolled hypertension\n* Unstable angina pectoris, myocardial infarction (MI), transient ischaemic attack (TIA), or stroke within 3 months prior to screening\n* Severe congestive heart failure"}, 'identificationModule': {'nctId': 'NCT03235050', 'briefTitle': 'A Study to Evaluate the Efficacy and Safety of MEDI0382 in the Treatment of Overweight and Obese Subjects With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase IIb, Randomised, Parallel, Double-Blind Placebo-Controlled and Open-Label Active Comparator Study to Evaluate the Efficacy and Safety of 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