Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2026-02-23 @ 8:31 PM
Study NCT ID:
NCT02963766
Status:
COMPLETED
Last Update Posted:
2022-07-01
First Post:
2016-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Dulaglutide (LY2189265) in Children and Adolescents With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada', 'China']}, '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': 'C555680', 'term': 'dulaglutide'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov@lilly.com', 'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up To 56 Weeks', 'description': 'All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo: Double-Blind Period', 'description': 'Participants received placebo administered SC for 26 weeks.', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 26, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': '0.75 mg Dulaglutide: Double-Blind Period', 'description': 'Participants received 0.75 mg/week dulaglutide administered SC for 26 weeks.', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 25, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': '1.5 mg Dulaglutide: Double-Blind Period', 'description': 'Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks.', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 28, 'seriousNumAtRisk': 52, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Placebo/0.75 mg Dulaglutide: Open Label Extension (OLE)', 'description': 'Participants who had received placebo during the double-blind period were given 0.75 mg/week dulaglutide administered SC for additional 26 weeks after the double-blind period.', 'otherNumAtRisk': 47, 'deathsNumAtRisk': 47, 'otherNumAffected': 18, 'seriousNumAtRisk': 47, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': '0.75 mg Dulaglutide: OLE', 'description': 'Participants received 0.75 mg/week dulaglutide administered SC for additional 26 weeks after the double-blind period.', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 16, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': '1.5 mg Dulaglutide: OLE', 'description': 'Participants received 1.5 mg/week dulaglutide administered SC for additional 26 weeks after the double-blind period.', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 20, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 50, 'numEvents': 21, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 13, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 19, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 50, 'numEvents': 21, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 16, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 13, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 10, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 50, 'numEvents': 12, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 14, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 50, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 21, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 50, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Heavy menstrual bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}], 'seriousEvents': [{'term': 'Right ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Nonalcoholic fatty liver disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Genital herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Pilonidal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Carbon monoxide poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Stress fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses) at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo administered SC for 26 weeks.'}, {'id': 'OG001', 'title': 'Pooled Dulaglutide', 'description': 'Participants received pooled: 0.75 mg/week dulaglutide and 1.5 mg/week dulaglutide administered SC for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '0.16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.3', 'ciLowerLimit': '-1.8', 'ciUpperLimit': '-0.7', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least square (LS) mean in HbA1c was calculated using a restricted maximum likelihood (REML) based mixed-effects model for repeated measures (MMRM) and adjusted by, baseline + insulin Use + metformin Use + treatment + time + treatment\\*time (Type III sum of squares). Variance-covariance structure = unstructured (for actual value) / unstructured (for change from baseline).', 'unitOfMeasure': 'percentage of HbA1C', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline HbA1c.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HbA1c (Individual Doses) at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo administered SC for 26 weeks.'}, {'id': 'OG001', 'title': '0.75 mg Dulaglutide', 'description': 'Participants received 0.75 mg/week dulaglutide administered SC for 26 weeks.'}, {'id': 'OG002', 'title': '1.5 mg Dulaglutide', 'description': 'Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.22', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': '0.22', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.0', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '-0.4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.5', 'ciLowerLimit': '-2.2', 'ciUpperLimit': '-0.9', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS mean in HbA1c was calculated using a REML based MMRM and adjusted by, baseline + insulin use + metformin use + treatment + time + treatment\\*time (Type III sum of squares). Variance-covariance structure = unstructured (for actual value) / unstructured (for change from baseline).', 'unitOfMeasure': 'percentage of HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline HbA1c.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Blood Glucose (FBG) at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '99', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo administered SC for 26 weeks.'}, {'id': 'OG001', 'title': '0.75 mg Dulaglutide', 'description': 'Participants received 0.75 mg/week dulaglutide administered SC for 26 weeks.'}, {'id': 'OG002', 'title': '1.5 mg Dulaglutide', 'description': 'Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks.'}, {'id': 'OG003', 'title': 'Pooled Dulaglutide', 'description': 'Participants received pooled: 0.75 mg/week dulaglutide and 1.5 mg/week dulaglutide administered SC for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.96', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '-0.47', 'spread': '0.41', 'groupId': 'OG001'}, {'value': '-1.54', 'spread': '0.41', 'groupId': 'OG002'}, {'value': '-1.03', 'spread': '0.29', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.021', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.44', 'ciLowerLimit': '-2.65', 'ciUpperLimit': '-0.22', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.51', 'ciLowerLimit': '-3.72', 'ciUpperLimit': '-1.29', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.97', 'ciLowerLimit': '-3.03', 'ciUpperLimit': '-0.91', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'Fasting blood glucose is a test to determine how much glucose (sugar) is in a blood sample after an overnight fast. Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) analysis and adjusted by baseline, strata, treatment, time, treatment\\*time, (Type III sum of squares). Variance-Covariance structure = Unstructured (for actual value) / Unstructured (for change from baseline). Strata refer to: insulin use + metformin use + baseline HbA1c group \\[ less than (\\<) 8%, greater than or equal to (\\>=) 8%).', 'unitOfMeasure': 'millimoles per liter (mmol/L)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had evaluable fasting blood glucose data. Only pre-rescue measurements were used.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HbA1c ≤7.0%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo administered SC for 26 weeks.'}, {'id': 'OG001', 'title': '0.75 mg Dulaglutide', 'description': 'Participants received 0.75 mg/week dulaglutide administered SC for 26 weeks.'}, {'id': 'OG002', 'title': '1.5 mg Dulaglutide', 'description': 'Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks.'}, {'id': 'OG003', 'title': 'Pooled Dulaglutide', 'description': 'Participants received pooled: 0.75 mg/week dulaglutide and 1.5 mg/week dulaglutide administered SC for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.42', 'groupId': 'OG000'}, {'value': '60.00', 'groupId': 'OG001'}, {'value': '53.19', 'groupId': 'OG002'}, {'value': '56.52', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.038', 'ciLowerLimit': '3.491', 'ciUpperLimit': '34.902', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.666', 'ciLowerLimit': '3.653', 'ciUpperLimit': '37.253', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.348', 'ciLowerLimit': '4.163', 'ciUpperLimit': '30.932', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 26', 'description': 'The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had evaluable baseline and post-baseline HbA1c.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Mass Index (BMI) at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '103', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo administered SC for 26 weeks.'}, {'id': 'OG001', 'title': '0.75 mg Dulaglutide', 'description': 'Participants received 0.75 mg/week dulaglutide administered SC for 26 weeks.'}, {'id': 'OG002', 'title': '1.5 mg Dulaglutide', 'description': 'Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks.'}, {'id': 'OG003', 'title': 'Pooled Dulaglutide', 'description': 'Participants received pooled: 0.75 mg/week dulaglutide and 1.5 mg/week dulaglutide administered SC for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.0', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '0.20', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '0.19', 'groupId': 'OG002'}, {'value': '-0.1', 'spread': '0.14', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.689', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '0.5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.924', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '0.5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.776', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '0.4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'BMI is an estimate of body fat based on body weight divided by height squared. LS mean were calculated using a MMRM analysis and adjusted by baseline, strata, treatment, time, treatment\\*time, (Type III sum of squares). Variance-Covariance structure = Unstructured (for actual value) / Unstructured (for change from baseline). Strata refer to: insulin use + metformin use + baseline HbA1c group (\\< 8%, \\>= 8%).', 'unitOfMeasure': 'kilograms/square meter (kg/m^2)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had evaluable BMI data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Self-Reported Events of Hypoglycemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo administered SC for 26 weeks.'}, {'id': 'OG001', 'title': '0.75 mg Dulaglutide', 'description': 'Participants received 0.75 mg/week dulaglutide administered SC for 26 weeks.'}, {'id': 'OG002', 'title': '1.5 mg Dulaglutide', 'description': 'Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.96', 'groupId': 'OG000'}, {'value': '3.92', 'groupId': 'OG001'}, {'value': '3.85', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 26', 'description': 'Summary and analysis of Incidence of all hypoglycemia with Plasma Glucose \\<54mg/dL.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Requiring Rescue for Severe, Persistent Hyperglycemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '103', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo administered SC for 26 weeks.'}, {'id': 'OG001', 'title': '0.75 mg Dulaglutide', 'description': 'Participants received 0.75 mg/week dulaglutide administered SC for 26 weeks.'}, {'id': 'OG002', 'title': '1.5 mg Dulaglutide', 'description': 'Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks.'}, {'id': 'OG003', 'title': 'Pooled Dulaglutide', 'description': 'Participants received pooled: 0.75 mg/week dulaglutide and 1.5 mg/week dulaglutide administered SC for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.6', 'groupId': 'OG000'}, {'value': '3.9', 'groupId': 'OG001'}, {'value': '1.9', 'groupId': 'OG002'}, {'value': '2.9', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 26', 'description': 'Percentage of Participants Requiring Rescue for Severe, Persistent Hyperglycemia was summarized.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adjudicated Pancreatitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '103', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo administered SC for 26 weeks.'}, {'id': 'OG001', 'title': '0.75 mg Dulaglutide', 'description': 'Participants received 0.75 mg/week dulaglutide administered SC for 26 weeks.'}, {'id': 'OG002', 'title': '1.5 mg Dulaglutide', 'description': 'Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks.'}, {'id': 'OG003', 'title': 'Pooled Dulaglutide', 'description': 'Participants received pooled: 0.75 mg/week dulaglutide and 1.5 mg/week dulaglutide administered SC for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 26', 'description': 'The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pancreatic Enzymes at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '103', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo administered SC for 26 weeks.'}, {'id': 'OG001', 'title': '0.75 mg Dulaglutide', 'description': 'Participants received 0.75 mg/week dulaglutide administered SC for 26 weeks.'}, {'id': 'OG002', 'title': '1.5 mg Dulaglutide', 'description': 'Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks.'}, {'id': 'OG003', 'title': 'Pooled Dulaglutide', 'description': 'Participants received pooled: 0.75 mg/week dulaglutide and 1.5 mg/week dulaglutide administered SC for 26 weeks.'}], 'classes': [{'title': 'Serum Amylase', 'categories': [{'measurements': [{'value': '0.09', 'spread': '17.36', 'groupId': 'OG000'}, {'value': '4.80', 'spread': '9.39', 'groupId': 'OG001'}, {'value': '6.50', 'spread': '8.91', 'groupId': 'OG002'}, {'value': '5.64', 'spread': '9.15', 'groupId': 'OG003'}]}]}, {'title': 'Serum Amylase, Pancreatic', 'categories': [{'measurements': [{'value': '0.60', 'spread': '9.94', 'groupId': 'OG000'}, {'value': '1.77', 'spread': '4.72', 'groupId': 'OG001'}, {'value': '2.90', 'spread': '6.10', 'groupId': 'OG002'}, {'value': '2.32', 'spread': '5.45', 'groupId': 'OG003'}]}]}, {'title': 'Serum Lipase', 'categories': [{'measurements': [{'value': '2.23', 'spread': '31.99', 'groupId': 'OG000'}, {'value': '4.37', 'spread': '8.28', 'groupId': 'OG001'}, {'value': '3.88', 'spread': '6.63', 'groupId': 'OG002'}, {'value': '4.12', 'spread': '7.47', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'Serum Amylase (total and pancreas-derived) and lipase concentrations were measured.', 'unitOfMeasure': 'Units/Liter (U/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had evaluable pancreatic enzymes data.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Thyroid Treatment-Emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '103', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo administered SC for 26 weeks.'}, {'id': 'OG001', 'title': '0.75 mg Dulaglutide', 'description': 'Participants received 0.75 mg/week dulaglutide administered SC for 26 weeks.'}, {'id': 'OG002', 'title': '1.5 mg Dulaglutide', 'description': 'Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks.'}, {'id': 'OG003', 'title': 'Pooled Dulaglutide', 'description': 'Participants received pooled: 0.75 mg/week dulaglutide and 1.5 mg/week dulaglutide administered SC for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 26', 'description': 'Number of Participants with Thyroid Treatment-Emergent Adverse Events were summarized.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Serum Calcitonin at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '96', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo administered SC for 26 weeks.'}, {'id': 'OG001', 'title': '0.75 mg Dulaglutide', 'description': 'Participants received 0.75 mg/week dulaglutide administered SC for 26 weeks.'}, {'id': 'OG002', 'title': '1.5 mg Dulaglutide', 'description': 'Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks.'}, {'id': 'OG003', 'title': 'Pooled Dulaglutide', 'description': 'Participants received pooled: 0.75 mg/week dulaglutide and 1.5 mg/week dulaglutide administered SC for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.38', 'spread': '1.70', 'groupId': 'OG000'}, {'value': '0.28', 'spread': '0.72', 'groupId': 'OG001'}, {'value': '0.10', 'spread': '0.50', 'groupId': 'OG002'}, {'value': '0.19', 'spread': '0.62', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'Change from Baseline in Serum Calcitonin was evaluated.', 'unitOfMeasure': 'nanograms per liter (ng/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had evaluable serum calcitonin data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Allergic, Hypersensitivity Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '103', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo administered SC for 26 weeks.'}, {'id': 'OG001', 'title': '0.75 mg Dulaglutide', 'description': 'Participants received 0.75 mg/week dulaglutide administered SC for 26 weeks.'}, {'id': 'OG002', 'title': '1.5 mg Dulaglutide', 'description': 'Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks.'}, {'id': 'OG003', 'title': 'Pooled Dulaglutide', 'description': 'Participants received pooled: 0.75 mg/week dulaglutide and 1.5 mg/week dulaglutide administered SC for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}, {'value': '3.9', 'groupId': 'OG001'}, {'value': '1.9', 'groupId': 'OG002'}, {'value': '2.9', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 26', 'description': 'The percentage of Participants with Allergic and hypersensitivity reactions that were considered possibly related to study drug by the investigator are presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Injection Site Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '103', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo administered SC for 26 weeks.'}, {'id': 'OG001', 'title': '0.75 mg Dulaglutide', 'description': 'Participants received 0.75 mg/week dulaglutide administered SC for 26 weeks.'}, {'id': 'OG002', 'title': '1.5 mg Dulaglutide', 'description': 'Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks.'}, {'id': 'OG003', 'title': 'Pooled Dulaglutide', 'description': 'Participants received pooled: 0.75 mg/week dulaglutide and 1.5 mg/week dulaglutide administered SC for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000'}, {'value': '9.8', 'groupId': 'OG001'}, {'value': '7.7', 'groupId': 'OG002'}, {'value': '8.7', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 26', 'description': 'The percentage of participants with at least one treatment-emergent injection site reaction is presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Anti-Dulaglutide Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/0.75 mg Dulaglutide', 'description': 'Participants received placebo administered SC for 26 weeks during the double-blind period and open-label 0.75 mg/week dulaglutide for 26 weeks during the open OLE.'}, {'id': 'OG001', 'title': '0.75 mg Dulaglutide', 'description': 'Participants received 0.75 mg/week dulaglutide administered SC for 26 weeks during the double-blind period and open-label 0.75 mg/week for 26 weeks during the OLE.'}, {'id': 'OG002', 'title': '1.5 mg Dulaglutide', 'description': 'Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks during the double-blind period and open-label 1.5 mg/week for 26 weeks during the OLE.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Week 56', 'description': 'Dulaglutide anti-drug antibodies (ADA) were assessed at baseline, Weeks 26 and 56. A participant was considered to have treatment-emergent (TE) dulaglutide ADAs if the participant had at least 1 titer that was TE relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had at least one post-baseline Dulaglutide ADA test result.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK): Maximum Concentration of Dulaglutide at Steady-state (Cmax,ss)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.75 mg Dulaglutide', 'description': 'Participants received 0.75 mg/week dulaglutide administered SC for 56 weeks.'}, {'id': 'OG001', 'title': '1.5 mg Dulaglutide', 'description': 'Participants received 1.5 mg/week dulaglutide administered SC for 56 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000', 'lowerLimit': '28.4', 'upperLimit': '33.5'}, {'value': '62', 'groupId': 'OG001', 'lowerLimit': '56.9', 'upperLimit': '67.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 9: pre-dose,1 to 12 hours post dose and 24 to 96 hours post dose; Week 13: predose and 1 to 12 hours post dose; Week 26: predose; Week 39: up to 2 days postdose; Week 52 and Week 56: PK sample can be taken at any time during the visit', 'description': 'PK: Maximum Concentration of Dulaglutide at steady-state (Cmax,ss) was derived by a population pharmacokinetics approach. As part of addendum, additional PK samples were taken at week 9.', 'unitOfMeasure': 'nanograms per milliliter (ng/mL)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had evaluable PK data.'}, {'type': 'SECONDARY', 'title': 'PK: Area Under the Concentration Time Curve Over a 1-week Interval of Dulaglutide at Steady-State [AUC(0-168)ss]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.75 mg Dulaglutide', 'description': 'Participants received 0.75 mg/week dulaglutide administered SC for 56 weeks.'}, {'id': 'OG001', 'title': '1.5 mg Dulaglutide', 'description': 'Participants received 1.5 mg/week dulaglutide administered SC for 56 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '4170', 'groupId': 'OG000', 'lowerLimit': '3770', 'upperLimit': '4510'}, {'value': '8350', 'groupId': 'OG001', 'lowerLimit': '7640', 'upperLimit': '9070'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 9: pre-dose,1 to 12 hours post dose and 24 to 96 hours post dose; Week 13: predose and 1 to 12 hours post dose; Week 26: predose; Week 39: up to 2 days postdose; Week 52 and Week 56: PK sample can be taken at any time during the visit', 'description': 'PK: Area Under the Concentration Time Curve over a 1-week interval of Dulaglutide at Steady-State \\[AUC(0-168)ss\\] was derived by a population pharmacokinetics approach. As part of addendum, additional PK samples were taken at week 9.', 'unitOfMeasure': 'nanogram*hour per milliliter (ng*h/ mL)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had evaluable PK data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo/0.75 Milligram (mg) Dulaglutide', 'description': 'Participants received placebo administered subcutaneously (SC) for 26 weeks during the double-blind period and open-label 0.75 mg/week dulaglutide for 26 weeks during the open Label Extension (OLE).'}, {'id': 'FG001', 'title': '0.75 mg Dulaglutide', 'description': 'Participants received 0.75 mg/week dulaglutide administered SC for 26 weeks during the double-blind period and open-label 0.75 mg/week for 26 weeks during the OLE.'}, {'id': 'FG002', 'title': '1.5 mg Dulaglutide', 'description': 'Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks during the double-blind period and open-label 1.5 mg/week for 26 weeks during the OLE.'}], 'periods': [{'title': 'Double-Blind Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '52'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '52'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '49'}, {'groupId': 'FG002', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Parent or Guardian', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Open Label Extension (OLE)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '49'}, {'groupId': 'FG002', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '46'}, {'groupId': 'FG002', 'numSubjects': '48'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '154', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo/0.75 mg Dulaglutide', 'description': 'Participants received placebo administered SC for 26 weeks during the double-blind period and open-label 0.75 mg/week dulaglutide for 26 weeks during the OLE.'}, {'id': 'BG001', 'title': '0.75 mg Dulaglutide', 'description': 'Participants received 0.75 mg/week dulaglutide administered SC for 26 weeks during the double-blind period and open-label 0.75 mg/week for 26 weeks during the OLE.'}, {'id': 'BG002', 'title': '1.5 mg Dulaglutide', 'description': 'Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks during the double-blind period and open-label 1.5 mg/week for 26 weeks during the OLE.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '14.20', 'spread': '2.08', 'groupId': 'BG000'}, {'value': '14.70', 'spread': '2.21', 'groupId': 'BG001'}, {'value': '14.70', 'spread': '1.81', 'groupId': 'BG002'}, {'value': '14.50', 'spread': '2.04', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '110', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '85', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '84', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Brazil', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'India', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}]}, {'title': 'Puerto Rico', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Saudi Arabia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Turkey', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '71', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Percentage of Hemoglobin A1c (HbA1c) at Baseline', 'classes': [{'categories': [{'measurements': [{'value': '8.14', 'spread': '1.12', 'groupId': 'BG000'}, {'value': '7.92', 'spread': '1.27', 'groupId': 'BG001'}, {'value': '8.16', 'spread': '1.39', 'groupId': 'BG002'}, {'value': '8.08', 'spread': '1.26', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percentage of HbA1c', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-10-15', 'size': 1502125, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-04-11T04:53', 'hasProtocol': True}, {'date': '2021-02-18', 'size': 5121391, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-04-11T04:57', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 154}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06-01', 'completionDateStruct': {'date': '2022-01-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-07', 'studyFirstSubmitDate': '2016-11-10', 'resultsFirstSubmitDate': '2022-06-07', 'studyFirstSubmitQcDate': '2016-11-10', 'lastUpdatePostDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-06-07', 'studyFirstPostDateStruct': {'date': '2016-11-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses) at Week 26', 'timeFrame': 'Baseline, Week 26', 'description': 'HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least square (LS) mean in HbA1c was calculated using a restricted maximum likelihood (REML) based mixed-effects model for repeated measures (MMRM) and adjusted by, baseline + insulin Use + metformin Use + treatment + time + treatment\\*time (Type III sum of squares). Variance-covariance structure = unstructured (for actual value) / unstructured (for change from baseline).'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in HbA1c (Individual Doses) at Week 26', 'timeFrame': 'Baseline, Week 26', 'description': 'HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS mean in HbA1c was calculated using a REML based MMRM and adjusted by, baseline + insulin use + metformin use + treatment + time + treatment\\*time (Type III sum of squares). Variance-covariance structure = unstructured (for actual value) / unstructured (for change from baseline).'}, {'measure': 'Change From Baseline in Fasting Blood Glucose (FBG) at Week 26', 'timeFrame': 'Baseline, Week 26', 'description': 'Fasting blood glucose is a test to determine how much glucose (sugar) is in a blood sample after an overnight fast. Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) analysis and adjusted by baseline, strata, treatment, time, treatment\\*time, (Type III sum of squares). Variance-Covariance structure = Unstructured (for actual value) / Unstructured (for change from baseline). Strata refer to: insulin use + metformin use + baseline HbA1c group \\[ less than (\\<) 8%, greater than or equal to (\\>=) 8%).'}, {'measure': 'Percentage of Participants With HbA1c ≤7.0%', 'timeFrame': 'Week 26', 'description': 'The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100.'}, {'measure': 'Change From Baseline in Body Mass Index (BMI) at Week 26', 'timeFrame': 'Baseline, Week 26', 'description': 'BMI is an estimate of body fat based on body weight divided by height squared. LS mean were calculated using a MMRM analysis and adjusted by baseline, strata, treatment, time, treatment\\*time, (Type III sum of squares). Variance-Covariance structure = Unstructured (for actual value) / Unstructured (for change from baseline). Strata refer to: insulin use + metformin use + baseline HbA1c group (\\< 8%, \\>= 8%).'}, {'measure': 'Percentage of Participants With Self-Reported Events of Hypoglycemia', 'timeFrame': 'Week 26', 'description': 'Summary and analysis of Incidence of all hypoglycemia with Plasma Glucose \\<54mg/dL.'}, {'measure': 'Percentage of Participants Requiring Rescue for Severe, Persistent Hyperglycemia', 'timeFrame': 'Week 26', 'description': 'Percentage of Participants Requiring Rescue for Severe, Persistent Hyperglycemia was summarized.'}, {'measure': 'Number of Participants With Adjudicated Pancreatitis', 'timeFrame': 'Week 26', 'description': 'The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.'}, {'measure': 'Change From Baseline in Pancreatic Enzymes at Week 26', 'timeFrame': 'Baseline, Week 26', 'description': 'Serum Amylase (total and pancreas-derived) and lipase concentrations were measured.'}, {'measure': 'Number of Participants With Thyroid Treatment-Emergent Adverse Events', 'timeFrame': 'Week 26', 'description': 'Number of Participants with Thyroid Treatment-Emergent Adverse Events were summarized.'}, {'measure': 'Change From Baseline in Serum Calcitonin at Week 26', 'timeFrame': 'Baseline, Week 26', 'description': 'Change from Baseline in Serum Calcitonin was evaluated.'}, {'measure': 'Percentage of Participants With Allergic, Hypersensitivity Reactions', 'timeFrame': 'Week 26', 'description': 'The percentage of Participants with Allergic and hypersensitivity reactions that were considered possibly related to study drug by the investigator are presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.'}, {'measure': 'Percentage of Participants With Injection Site Reactions', 'timeFrame': 'Week 26', 'description': 'The percentage of participants with at least one treatment-emergent injection site reaction is presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.'}, {'measure': 'Number of Participants With Anti-Dulaglutide Antibodies', 'timeFrame': 'Baseline through Week 56', 'description': 'Dulaglutide anti-drug antibodies (ADA) were assessed at baseline, Weeks 26 and 56. A participant was considered to have treatment-emergent (TE) dulaglutide ADAs if the participant had at least 1 titer that was TE relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement.'}, {'measure': 'Pharmacokinetics (PK): Maximum Concentration of Dulaglutide at Steady-state (Cmax,ss)', 'timeFrame': 'Week 9: pre-dose,1 to 12 hours post dose and 24 to 96 hours post dose; Week 13: predose and 1 to 12 hours post dose; Week 26: predose; Week 39: up to 2 days postdose; Week 52 and Week 56: PK sample can be taken at any time during the visit', 'description': 'PK: Maximum Concentration of Dulaglutide at steady-state (Cmax,ss) was derived by a population pharmacokinetics approach. As part of addendum, additional PK samples were taken at week 9.'}, {'measure': 'PK: Area Under the Concentration Time Curve Over a 1-week Interval of Dulaglutide at Steady-State [AUC(0-168)ss]', 'timeFrame': 'Week 9: pre-dose,1 to 12 hours post dose and 24 to 96 hours post dose; Week 13: predose and 1 to 12 hours post dose; Week 26: predose; Week 39: up to 2 days postdose; Week 52 and Week 56: PK sample can be taken at any time during the visit', 'description': 'PK: Area Under the Concentration Time Curve over a 1-week interval of Dulaglutide at Steady-State \\[AUC(0-168)ss\\] was derived by a population pharmacokinetics approach. As part of addendum, additional PK samples were taken at week 9.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pediatrics'], 'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '39963952', 'type': 'DERIVED', 'citation': 'Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2.'}, {'pmid': '35658022', 'type': 'DERIVED', 'citation': 'Arslanian SA, Hannon T, Zeitler P, Chao LC, Boucher-Berry C, Barrientos-Perez M, Bismuth E, Dib S, Cho JI, Cox D; AWARD-PEDS Investigators. Once-Weekly Dulaglutide for the Treatment of Youths with Type 2 Diabetes. N Engl J Med. 2022 Aug 4;387(5):433-443. doi: 10.1056/NEJMoa2204601. Epub 2022 Jun 4.'}], 'seeAlsoLinks': [{'url': 'https://trials.lillytrialguide.com/en-US/trial/5RwyJT8t9uI0ISG4U4SEu0', 'label': 'A Study of Dulaglutide (LY2189265) in Children and Adolescents With Type 2 Diabetes (AWARD-PEDS)'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of the study drug dulaglutide compared to placebo in pediatric participants with type 2 diabetes. The study duration is approximately 60 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have type 2 diabetes, treated with diet and exercise, with or without metformin and/or basal insulin. Metformin and/or basal insulin dose must be stable for at least 8 weeks prior to study screening.\n* Have HbA1c \\>6.5% to ≤11% at screening visit. If newly diagnosed and not on medicine for diabetes, HbA1c must be between \\>6.5 % to ≤9%.\n* Have a BMI (body mass index) \\>85 percentile for age, gender and body weight ≥50 kilograms (110 pounds).\n\nExclusion Criteria:\n\n* Known type 1 diabetes, or positive GAD65 or IA2 antibodies, or history of diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome.\n* A history of, or at risk for pancreatitis.\n* Self or family history of Multiple Endocrine Neoplasia (MEN) type 2A or B, thyroid C-cell hyperplasia or medullary thyroid cancer, or a blood calcitonin result ≥20 picograms per milliliter (pg/ml) at screening.\n* A systolic blood pressure of ≥160 millimeters of mercury (mmHg) or diastolic ≥100 mmHg.\n* Active or treated cancer.\n* A blood disorder where an accurate HbA1c may not be obtainable.\n* A female of childbearing age, sexually active and not on birth control.\n* Pregnant or plan to be pregnant during the study, or breastfeeding.\n* Taking any diabetic medication other than metformin or basal insulin and have not stopped it 3 months prior to the screening visit (6 weeks for bolus or mealtime insulin).\n* Have taken oral steroids within the last 60 days or more than 20 days use within the past year or 1000 micrograms fluticasone propionate per day.\n* Using prescription weight loss medications in the last 30 days, or plan to use.\n* Taking psychiatric medications for depression or illness or attention deficit hyperactivity disorder (ADHD) if, the doses has changed within the last 3 months.'}, 'identificationModule': {'nctId': 'NCT02963766', 'acronym': 'AWARD-PEDS', 'briefTitle': 'A Study of Dulaglutide (LY2189265) in Children and Adolescents With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Randomized, Double-Blind Study With an Open-Label Extension Comparing the Effect of Once-Weekly Dulaglutide With Placebo in Pediatric Patients With Type 2 Diabetes Mellitus (AWARD-PEDS: Assessment of Weekly AdministRation of LY2189265 in Diabetes-PEDiatric Study)', 'orgStudyIdInfo': {'id': '14171'}, 'secondaryIdInfos': [{'id': 'H9X-MC-GBGC', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': '2016-000361-22', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Placebo/0.75 milligram (mg) Dulaglutide', 'description': 'Participants received placebo administered subcutaneously (SC) for 26 weeks during the double-blind period and open-label 0.75 mg/week dulaglutide for 26 weeks during the Open Label Extension (OLE).', 'interventionNames': ['Drug: Dulaglutide', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '0.75 mg Dulaglutide', 'description': 'Participants received 0.75 mg/week dulaglutide administered SC for 26 weeks during the double-blind period and open-label 0.75 mg/week for 26 weeks during the OLE.', 'interventionNames': ['Drug: Dulaglutide']}, {'type': 'EXPERIMENTAL', 'label': '1.5 mg Dulaglutide', 'description': 'Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks during the double-blind period and open-label 1.5 mg/week for 26 weeks during the OLE.', 'interventionNames': ['Drug: Dulaglutide']}], 'interventions': [{'name': 'Dulaglutide', 'type': 'DRUG', 'otherNames': ['LY2189265'], 'description': 'Administered SC', 'armGroupLabels': ['0.75 mg Dulaglutide', '1.5 mg Dulaglutide', 'Placebo/0.75 milligram (mg) Dulaglutide']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['Placebo/0.75 milligram (mg) Dulaglutide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92805', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Advanced Research Center', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Division of Endocrinology, Diabetes, and Metabolism', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Childrens Hospital of Orange County', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '95821', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Center of Excellence in Diabetes & Endocrinology', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Rady Childrens Hospital - San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '95148', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'JC Cabaccan', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '94592', 'city': 'Vallejo', 'state': 'California', 'country': 'United States', 'facility': 'Touro University', 'geoPoint': {'lat': 38.10409, 'lon': -122.25664}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': "Children's National Medical Center", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Center for Endocrinology & Metabolism', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '83712', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': "St. Luke's Regional Medical Center", 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois at Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Health Hospital', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '70808-4124', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Pennington Biomedical Research Center', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Children's Mercy Hospital", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '27834', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'ECU Pediatric Specialty Care', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cincinnati Childrens Hospital Medical Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15224', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Childrens Hospital of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Seattle Children's Hospital Research Foundation", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Multicare Health System', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'zip': '25302', 'city': 'Charleston', 'state': 'West Virginia', 'country': 'United States', 'facility': 'CAMC Institute', 'geoPoint': {'lat': 38.34982, 'lon': -81.63262}}, {'zip': '20211-340', 'city': 'Rio de Janeiro', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Instituto Estadual de Diabetes e Endocrinologia', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': '90430-001', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Centro de Pesquisas em Diabetes', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '91350-200', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Instituto da Criança com Diabetes', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '13034-685', 'city': 'Campinas', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital PUC-CAMPINAS', 'geoPoint': {'lat': -22.90556, 'lon': -47.06083}}, {'zip': '14051-140', 'city': 'Ribeirão Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital das Clinicas da FMRP', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}, {'zip': '01228-200', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'CPCLIN', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '05403-000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital da Clinicas da Faculdade de Medicina da USP', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '04022-001', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'UNIFESP - Escola Paulista de Medicina', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '94275', 'city': 'Le Kremlin-Bicêtre', 'country': 'France', 'facility': 'Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'zip': '75019', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Robert Debre', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '56727', 'city': 'Mayen', 'state': 'Rhineland-Palatinate', 'country': 'Germany', 'facility': 'Praxis Dr. med. Landers', 'geoPoint': {'lat': 50.32797, 'lon': 7.22277}}, {'zip': '66386', 'city': 'Sankt Ingbert', 'state': 'Saarland', 'country': 'Germany', 'facility': 'Zentrum für klinische Studien', 'geoPoint': {'lat': 49.27697, 'lon': 7.11672}}, {'zip': '23758', 'city': 'Oldenburg in Holstein', 'state': 'Schleswig-Holstein', 'country': 'Germany', 'facility': 'RED-Institut GmbH', 'geoPoint': {'lat': 54.29498, 'lon': 10.89043}}, {'zip': '1089', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Heim Pal Gyermekkorhaz', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '380007', 'city': 'Ahmedabad', 'state': 'Gujarat', 'country': 'India', 'facility': 'Dr Jivraj Mehta Smarak Health Foundation Bakeri Medical Research Centre', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'zip': '560017', 'city': 'Bangalore', 'state': 'Karmnataka', 'country': 'India', 'facility': 'Manipal Hospital', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '560054', 'city': 'Bangalore', 'state': 'Karnataka', 'country': 'India', 'facility': 'M S Ramaiah Medical College Hospital', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '411004', 'city': 'Pune', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Deenanath Mangeshkar Hospital & Research Centre', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'zip': '110060', 'city': 'New Delhi', 'state': 'National Capital Territory of Delhi', 'country': 'India', 'facility': 'Sir Ganga Ram Hospital', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}, {'zip': '160012', 'city': 'Chandigarh', 'state': 'Punjab', 'country': 'India', 'facility': 'Post Graduate Institute of Medical Education & Research'}, {'zip': '221005', 'city': 'Varanasi', 'state': 'Uttar Pradesh', 'country': 'India', 'facility': 'Banaras Hindu University - BHU', 'geoPoint': {'lat': 25.31668, 'lon': 83.01041}}, {'zip': '700017', 'city': 'Kolkata', 'state': 'West Bengal', 'country': 'India', 'facility': 'Park Clinic', 'geoPoint': {'lat': 22.56263, 'lon': 88.36304}}, {'zip': '700054', 'city': 'Kolkata', 'state': 'West Bengal', 'country': 'India', 'facility': 'Apollo Gleneagles Hospitals Kolkata', 'geoPoint': {'lat': 22.56263, 'lon': 88.36304}}, {'zip': '03810', 'city': 'Mexico City', 'state': 'Federal District', 'country': 'Mexico', 'facility': 'Health Pharma Professional Research, S.A. de C.V.', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '45116', 'city': 'Zapopan', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'Centro de Inv. Medica de Occidente, SC', 'geoPoint': {'lat': 20.72111, 'lon': -103.38742}}, {'zip': '64710', 'city': 'Monterrey', 'state': 'Nuevo León', 'country': 'Mexico', 'facility': 'Centro Medico San Francisco', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}, {'zip': '89249', 'city': 'Tampico', 'state': 'Tamaulipas', 'country': 'Mexico', 'facility': 'Cli-nica Hospital Cemain', 'geoPoint': {'lat': 22.28519, 'lon': -97.87777}}, {'zip': '72190', 'city': 'Puebla City', 'country': 'Mexico', 'facility': 'Hospital Angeles Puebla', 'geoPoint': {'lat': 19.04778, 'lon': -98.20723}}, {'zip': '91910', 'city': 'Veracruz', 'country': 'Mexico', 'facility': 'Arke Estudios Clinicos S.A. de C.V.', 'geoPoint': {'lat': 19.18095, 'lon': -96.1429}}, {'zip': '00959', 'city': 'Bayamón', 'state': 'PR', 'country': 'Puerto Rico', 'facility': 'Centro de Diabetes y Endocrinologia Pediatrica de PR', 'geoPoint': {'lat': 18.39856, 'lon': -66.15572}}, {'zip': '11472', 'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'King Saud University Hospital', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}, {'zip': '12769', 'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'King Salman bin Abdulaziz Hospital - Diabetic Center', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}, {'zip': '06100', 'city': 'Ankara', 'state': 'Mamak', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara University Medicine Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '06080', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Sami Ulus Education & Research Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '81620', 'city': 'Düzce', 'country': 'Turkey (Türkiye)', 'facility': 'Duzce University Medical Faculty', 'geoPoint': {'lat': 40.83889, 'lon': 31.16389}}, {'zip': '55139', 'city': 'Samsun', 'country': 'Turkey (Türkiye)', 'facility': 'Ondokuz Mayis University Medical Faculty', 'geoPoint': {'lat': 41.27976, 'lon': 36.3361}}, {'zip': 'L14 5AB', 'city': 'Liverpool', 'state': 'Lancashire', 'country': 'United Kingdom', 'facility': "Alder Hey Children's Hospital", 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'zip': 'LS9 7TF', 'city': 'Leeds', 'state': 'West Yorkshire', 'country': 'United Kingdom', 'facility': "St James's University Hospital", 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'ipdSharingStatementModule': {'url': 'https://www.vivli.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.', 'ipdSharing': 'YES', 'description': 'Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.', 'accessCriteria': 'A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}