Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:12 AM
Study NCT ID:
NCT04809220
Status:
COMPLETED
Last Update Posted:
2024-05-22
First Post:
2021-03-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of Two Doses of Dulaglutide (LY2189265) in Japanese Patients With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}], 'ancestors': [{'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C555680', 'term': 'dulaglutide'}, {'id': 'D007004', 'term': 'Hypoglycemic Agents'}], 'ancestors': [{'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, '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': 'Baseline to Week 56.', 'description': 'All randomly assigned participants, excluding the GCP compliance investigative site, who were exposed to at least 1 dose of study intervention. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.', 'eventGroups': [{'id': 'EG000', 'title': 'Dulaglutide 1.5 mg', 'description': 'Participants received 1.5 mg of dulaglutide given weekly SC during the 52-week treatment period. Dulaglutide will be given alone or in combination with 1 OAM. Participants on DPP-4i discontinued DPP-4i at randomization and was regarded as monotherapy of dulaglutide, other OAMs continued at same dose during study period and were regarded as combination therapy with dulaglutide.', 'otherNumAtRisk': 391, 'deathsNumAtRisk': 391, 'otherNumAffected': 298, 'seriousNumAtRisk': 391, 'deathsNumAffected': 1, 'seriousNumAffected': 15}, {'id': 'EG001', 'title': 'Dulaglutide 0.75 mg', 'description': 'Participants received 0.75 mg of dulaglutide given weekly SC during the 52-week treatment period. Dulaglutide will be given alone or in combination with 1 OAM. Participants on DPP-4i discontinued DPP-4i at randomization and was regarded as monotherapy of dulaglutide, other OAMs continued at same dose during study period and were regarded as combination therapy with dulaglutide.', 'otherNumAtRisk': 195, 'deathsNumAtRisk': 195, 'otherNumAffected': 143, 'seriousNumAtRisk': 195, 'deathsNumAffected': 0, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Splenomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Bundle branch block right', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Supraventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Deafness neurosensory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Presbyacusis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Sudden hearing loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Age-related macular degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Asthenopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Blepharitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Central serous chorioretinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Conjunctival deposit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Conjunctivitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Corneal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Diabetic retinal oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Diabetic retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Eczema eyelids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Macular oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Ocular hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Retinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Retinal tear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Retinal vein occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 26, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Anal fissure haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Anal fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cheilitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Chronic gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Colitis ischaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 51, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 138, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 17, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Diverticulum intestinal haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Duodenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 17, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Ectopic gastric mucosa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Eructation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Faeces hard', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Faeces soft', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Food poisoning', 'stats': [{'groupId': 'EG000', 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'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Tumour excision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypotension', 'stats': 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'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Retinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Vitreous haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Brain stem haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 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Participants on DPP-4i discontinued DPP-4i at randomization and was regarded as monotherapy of dulaglutide, other OAMs continued at same dose during study period and were regarded as combination therapy with dulaglutide.'}], 'classes': [{'title': 'HbA1c ≤ 6.5%', 'categories': [{'measurements': [{'value': '22.88', 'groupId': 'OG000'}, {'value': '21.26', 'groupId': 'OG001'}]}]}, {'title': 'HbA1c < 7%', 'categories': [{'measurements': [{'value': '46.33', 'groupId': 'OG000'}, {'value': '38.51', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.560', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.15', 'ciLowerLimit': '0.71', 'ciUpperLimit': '1.87', 'groupDescription': 'For HbA1c ≤6.5%', 'statisticalMethod': 'Generalized Linear Mixed Model (GLM)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.028', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.61', 'ciLowerLimit': '1.05', 'ciUpperLimit': '2.45', 'groupDescription': 'For HbA1c \\< 7%', 'statisticalMethod': 'Generalized Linear Mixed Model (GLM)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'description': 'HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. The odds ratios, confidence intervals, and p-values were determined by generalized linear mixed model (GLM) with Baseline + Pre-study OAM Group 1 + Treatment + Time + Treatment × Time as variables.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomly assigned participants, excluding the GCP compliance investigative site, who were exposed to at least 1 dose of study intervention and had at least one post baseline value for this analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Serum Glucose (FSG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '382', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dulaglutide 1.5 mg', 'description': 'Participants received 1.5 mg of dulaglutide given weekly SC during the 52-week treatment period. Dulaglutide will be given alone or in combination with 1 OAM. Participants on DPP-4i discontinued DPP-4i at randomization and was regarded as monotherapy of dulaglutide, other OAMs continued at same dose during study period and were regarded as combination therapy with dulaglutide.'}, {'id': 'OG001', 'title': 'Dulaglutide 0.75 mg', 'description': 'Participants received 0.75 mg of dulaglutide given weekly SC during the 52-week treatment period. Dulaglutide will be given alone or in combination with 1 OAM. Participants on DPP-4i discontinued DPP-4i at randomization and was regarded as monotherapy of dulaglutide, other OAMs continued at same dose during study period and were regarded as combination therapy with dulaglutide.'}], 'classes': [{'categories': [{'measurements': [{'value': '-42.4', 'spread': '1.47', 'groupId': 'OG000'}, {'value': '-33.1', 'spread': '2.09', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.4', 'ciLowerLimit': '-14.4', 'ciUpperLimit': '-4.3', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'FSG is a test to determine sugar levels in serum sample after an overnight fast. LS mean was determined by MMRM model with Baseline + Baseline HbA1c (High, Low) Group, OAM-based + Pre-study OAM Group 1 + Treatment + Time + Treatment\\*Time as variables.', 'unitOfMeasure': 'milligrams per deciliter (mg/dL)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomly assigned participants, excluding the GCP compliance investigative site, who were exposed to at least 1 dose of study intervention and had at least one post baseline value for this analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 6-point Self-Monitored Blood Glucose (SMBG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dulaglutide 1.5 mg', 'description': 'Participants received 1.5 mg of dulaglutide given weekly SC during the 52-week treatment period. Dulaglutide will be given alone or in combination with 1 OAM. Participants on DPP-4i discontinued DPP-4i at randomization and was regarded as monotherapy of dulaglutide, other OAMs continued at same dose during study period and were regarded as combination therapy with dulaglutide.'}, {'id': 'OG001', 'title': 'Dulaglutide 0.75 mg', 'description': 'Participants received 0.75 mg of dulaglutide given weekly SC during the 52-week treatment period. Dulaglutide will be given alone or in combination with 1 OAM. Participants on DPP-4i discontinued DPP-4i at randomization and was regarded as monotherapy of dulaglutide, other OAMs continued at same dose during study period and were regarded as combination therapy with dulaglutide.'}], 'classes': [{'title': 'Morning premeal-fasting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-45.6', 'spread': '1.33', 'groupId': 'OG000'}, {'value': '-38.4', 'spread': '1.86', 'groupId': 'OG001'}]}]}, {'title': 'Morning 2-hour post meal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-70.6', 'spread': '2.42', 'groupId': 'OG000'}, {'value': '-60.5', 'spread': '3.39', 'groupId': 'OG001'}]}]}, {'title': 'Midday premeal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-55.3', 'spread': '1.77', 'groupId': 'OG000'}, {'value': '-47.0', 'spread': '2.47', 'groupId': 'OG001'}]}]}, {'title': 'Midday 2-hour post meal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-73.7', 'spread': '2.37', 'groupId': 'OG000'}, {'value': '-61.2', 'spread': '3.32', 'groupId': 'OG001'}]}]}, {'title': 'Evening premeal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-50.3', 'spread': '1.60', 'groupId': 'OG000'}, {'value': '-46.4', 'spread': '2.24', 'groupId': 'OG001'}]}]}, {'title': 'Evening 2-hour post meal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '360', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-61.1', 'spread': '2.27', 'groupId': 'OG000'}, {'value': '-49.8', 'spread': '3.18', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.2', 'ciLowerLimit': '-11.7', 'ciUpperLimit': '-2.7', 'groupDescription': 'Morning premeal-fasting', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.016', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.1', 'ciLowerLimit': '-18.3', 'ciUpperLimit': '-1.9', 'groupDescription': 'Morning 2-hour post meal', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.3', 'ciLowerLimit': '-14.2', 'ciUpperLimit': '-2.3', 'groupDescription': 'Midday premeal', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.5', 'ciLowerLimit': '-20.5', 'ciUpperLimit': '-4.5', 'groupDescription': 'Midday 2-hour post meal', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.158', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.9', 'ciLowerLimit': '-9.3', 'ciUpperLimit': '1.5', 'groupDescription': 'Evening premeal', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.3', 'ciLowerLimit': '-19.0', 'ciUpperLimit': '-3.7', 'groupDescription': 'Evening 2-hour post meal', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'SMBG 6-point profiles were measured at morning (premeal-fasting, 2-hour post meal), midday (premeal, 2-hour post meal), and evening (premeal, 2-hour post meal). LS mean was determined by analysis of covariance (ANCOVA) model with Baseline + Baseline HbA1c (High, Low) Group, OAM-based + Pre-study OAM Group 1 + Treatment as variables.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomly assigned participants, excluding the GCP compliance investigative site, who were exposed to at least 1 dose of study intervention and had at least one post baseline value for this analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '383', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dulaglutide 1.5 mg', 'description': 'Participants received 1.5 mg of dulaglutide given weekly SC during the 52-week treatment period. Dulaglutide will be given alone or in combination with 1 OAM. Participants on DPP-4i discontinued DPP-4i at randomization and was regarded as monotherapy of dulaglutide, other OAMs continued at same dose during study period and were regarded as combination therapy with dulaglutide.'}, {'id': 'OG001', 'title': 'Dulaglutide 0.75 mg', 'description': 'Participants received 0.75 mg of dulaglutide given weekly SC during the 52-week treatment period. Dulaglutide will be given alone or in combination with 1 OAM. Participants on DPP-4i discontinued DPP-4i at randomization and was regarded as monotherapy of dulaglutide, other OAMs continued at same dose during study period and were regarded as combination therapy with dulaglutide.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '0.19', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.213', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '0.2', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'LS mean was determined by MMRM model with Baseline + Baseline HbA1c (High, Low) Group, OAM-based + Pre-study OAM Group 1 + Treatment + Time + Treatment\\*Time as variables.', 'unitOfMeasure': 'kilogram (kg)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomly assigned participants, excluding the GCP compliance investigative site, who were exposed to at least 1 dose of study intervention and had at least one post baseline value for this analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dulaglutide 1.5 Milligram (mg)', 'description': 'Participants received 1.5 mg of dulaglutide given weekly SC during the 52-week treatment period. Dulaglutide will be given alone or in combination with 1 OAM. Participants on DPP-4i discontinued DPP-4i at randomization and was regarded as monotherapy of dulaglutide, other OAMs continued at same dose during study period and were regarded as combination therapy with dulaglutide.'}, {'id': 'FG001', 'title': 'Dulaglutide 0.75 mg', 'description': 'Participants received 0.75 mg of dulaglutide given weekly SC during the 52-week treatment period. Dulaglutide will be given alone or in combination with 1 OAM. Participants on DPP-4i discontinued DPP-4i at randomization and was regarded as monotherapy of dulaglutide, other OAMs continued at same dose during study period and were regarded as combination therapy with dulaglutide.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '395'}, {'groupId': 'FG001', 'numSubjects': '196'}]}, {'type': 'Exposed to at Least 1 Dose of Study Intervention (Excluding the GCP Compliance Investigative Site)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '391'}, {'groupId': 'FG001', 'numSubjects': '195'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '377'}, {'groupId': 'FG001', 'numSubjects': '190'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Due to long-term overseas business trips', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '591 participants were randomized in the study. However, due to good clinical practice (GCP) compliance issues identified at one of the investigative sites, all 5 participants from that site were excluded from the study analyses.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'BG000'}, {'value': '195', 'groupId': 'BG001'}, {'value': '586', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Dulaglutide 1.5 mg', 'description': 'Participants received 1.5 mg of dulaglutide given weekly SC during the 52-week treatment period. Dulaglutide will be given alone or in combination with 1 OAM. Participants on DPP-4i discontinued DPP-4i at randomization and was regarded as monotherapy of dulaglutide, other OAMs continued at same dose during study period and were regarded as combination therapy with dulaglutide.'}, {'id': 'BG001', 'title': 'Dulaglutide 0.75 mg', 'description': 'Participants received 0.75 mg of dulaglutide given weekly SC during the 52-week treatment period. Dulaglutide will be given alone or in combination with 1 OAM. Participants on DPP-4i discontinued DPP-4i at randomization and was regarded as monotherapy of dulaglutide, other OAMs continued at same dose during study period and were regarded as combination therapy with dulaglutide.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.10', 'spread': '10.70', 'groupId': 'BG000'}, {'value': '60.70', 'spread': '10.74', 'groupId': 'BG001'}, {'value': '60.30', 'spread': '10.71', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '113', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '166', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '278', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '420', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '391', 'groupId': 'BG000'}, {'value': '195', 'groupId': 'BG001'}, {'value': '586', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '391', 'groupId': 'BG000'}, {'value': '195', 'groupId': 'BG001'}, {'value': '586', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Hemoglobin A1c (HbA1c)', 'classes': [{'categories': [{'measurements': [{'value': '8.61', 'spread': '0.62', 'groupId': 'BG000'}, {'value': '8.61', 'spread': '0.60', 'groupId': 'BG001'}, {'value': '8.61', 'spread': '0.61', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time.', 'unitOfMeasure': 'Percentage of HbA1c', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All randomly assigned participants, excluding the GCP compliance investigative site, who were exposed to at least 1 dose of study intervention.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-12-15', 'size': 1566134, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-08-08T03:11', 'hasProtocol': True}, {'date': '2022-10-14', 'size': 1080373, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-08-08T03:01', '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': 591}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-04-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-25', 'studyFirstSubmitDate': '2021-03-19', 'resultsFirstSubmitDate': '2023-08-24', 'studyFirstSubmitQcDate': '2021-03-19', 'lastUpdatePostDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-08-24', 'studyFirstPostDateStruct': {'date': '2021-03-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26', 'timeFrame': 'Baseline, Week 26', 'description': 'HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Pre-study oral antihyperglycemic medication (OAM) Group 1 + Treatment + Time + Treatment × Time as variables.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in HbA1c at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. LS mean was determined by MMRM model with Baseline + Pre-study OAM Group 1 + Treatment + Time + Treatment × Time as variables.'}, {'measure': 'Percentage of Participants Achieving HbA1c Target ≤6.5% and <7.0%', 'timeFrame': 'Week 52', 'description': 'HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. The odds ratios, confidence intervals, and p-values were determined by generalized linear mixed model (GLM) with Baseline + Pre-study OAM Group 1 + Treatment + Time + Treatment × Time as variables.'}, {'measure': 'Change From Baseline in Fasting Serum Glucose (FSG)', 'timeFrame': 'Baseline, Week 52', 'description': 'FSG is a test to determine sugar levels in serum sample after an overnight fast. LS mean was determined by MMRM model with Baseline + Baseline HbA1c (High, Low) Group, OAM-based + Pre-study OAM Group 1 + Treatment + Time + Treatment\\*Time as variables.'}, {'measure': 'Change From Baseline in 6-point Self-Monitored Blood Glucose (SMBG)', 'timeFrame': 'Baseline, Week 26', 'description': 'SMBG 6-point profiles were measured at morning (premeal-fasting, 2-hour post meal), midday (premeal, 2-hour post meal), and evening (premeal, 2-hour post meal). LS mean was determined by analysis of covariance (ANCOVA) model with Baseline + Baseline HbA1c (High, Low) Group, OAM-based + Pre-study OAM Group 1 + Treatment as variables.'}, {'measure': 'Change From Baseline in Body Weight', 'timeFrame': 'Baseline, Week 52', 'description': 'LS mean was determined by MMRM model with Baseline + Baseline HbA1c (High, Low) Group, OAM-based + Pre-study OAM Group 1 + Treatment + Time + Treatment\\*Time as variables.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus', 'Diabetes Mellitus, Type 2', 'Glucose Metabolism Disorders', 'Metabolic Disease', 'Endocrine System Diseases', 'Hypoglycemic Agents', 'Type 2 Diabetes Mellitus (T2DM)']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of 2 doses of dulaglutide in Japanese participants with type 2 diabetes. The study duration is approximately 58 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants with type 2 diabetes (T2D) ≥ 6 months according to the World Health Organization (WHO) classification.\n* Treated with stable doses of a single OAM for at least 8 weeks prior to screening; the dose must be more than or equal to minimum maintenance dose.\n* Have the following HbA1c result at screening.\n\n * Participants taking DPP-4i: ≥7.5% and ≤9.5%,\n * Participants taking another OAM: ≥8.0% and ≤10.0%\n* Stable body weight for at least 8 weeks prior to screening or not changed by more than 5 % in the past 8 weeks\n* Have a body mass index (BMI) ≥18.5 kilogram/square meter (kg/m²) and \\<35 kg/m² at Day 1.\n\nExclusion Criteria:\n\n* Have type 1 diabetes (T1D)\n* Have a history of ≥1 episode of ketoacidosis or hyperosmolar state/coma\n* Have had any myocardial infarction (MI), heart failure or cerebrovascular accident (stroke)\n* Have a known clinically significant gastric empty abnormality\n* Have acute or chronic hepatitis\n* Have had chronic or acute pancreatitis\n* Have any self or family history of type 2A or type 2B multiple endocrine neoplasia in the absence of known C-cell hyperplasia\n* Have any self or family history of medullary C-cell hyperplasia, focal hyperplasia, or carcinoma (including sporadic, familial, or part of Multiple endocrine neoplasia (MEN) 2A or 2B syndrome)\n* Have evidence of significant, active autoimmune abnormality\n* Have evidence of significant, uncontrolled endocrine abnormality\n* Have active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer) for less than 5 years\n* Have any hematologic condition that may interfere with HbA1c measurement'}, 'identificationModule': {'nctId': 'NCT04809220', 'acronym': 'AWARD-JPN', 'briefTitle': 'A Study of Two Doses of Dulaglutide (LY2189265) in Japanese Patients With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Randomized, Double-Blind, Parallel Arm Study of the Efficacy and Safety of Two Doses of Dulaglutide in Combination With a Single Oral Antihyperglycemic Medication or as Monotherapy in Japanese Patients With Type 2 Diabetes Mellitus (AWARD-JPN: Assessment of Weekly Administration of LY2189265 in Diabetes - JAPAN)', 'orgStudyIdInfo': {'id': '17779'}, 'secondaryIdInfos': [{'id': 'H9X-JE-GBGQ', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dulaglutide 1.5 milligram (mg)', 'description': 'Participants received 1.5 mg of dulaglutide given weekly subcutaneously (SC) during the 52-week treatment period. Dulaglutide will be given alone or in combination with 1 oral antihyperglycemic medication (OAM). Participants on dipeptidyl peptidase-4 inhibitors (DPP-4i) discontinued DPP-4i at randomization and was regarded as monotherapy of dulaglutide, other OAMs continued at same dose during study period and were regarded as combination therapy with dulaglutide.', 'interventionNames': ['Drug: Dulaglutide', 'Drug: Oral antihyperglycemics']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dulaglutide 0.75 mg', 'description': 'Participants received 0.75 mg of dulaglutide given weekly SC during the 52-week treatment period. Dulaglutide will be given alone or in combination with 1 OAM. Participants on DPP-4i discontinued DPP-4i at randomization and was regarded as monotherapy of dulaglutide, other OAMs continued at same dose during study period and were regarded as combination therapy with dulaglutide.', 'interventionNames': ['Drug: Dulaglutide', 'Drug: Oral antihyperglycemics']}], 'interventions': [{'name': 'Dulaglutide', 'type': 'DRUG', 'otherNames': ['LY2189265'], 'description': 'Administered SC', 'armGroupLabels': ['Dulaglutide 0.75 mg', 'Dulaglutide 1.5 milligram (mg)']}, {'name': 'Oral antihyperglycemics', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Dulaglutide 0.75 mg', 'Dulaglutide 1.5 milligram (mg)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '456-0058', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Nakayama Clinic', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '468-0009', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Tosaki Clinic for Diabetes and Endocrinology', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '277-0825', 'city': 'Kashiwa', 'state': 'Chiba', 'country': 'Japan', 'facility': 'Kashiwa City Hospital', 'geoPoint': {'lat': 35.86224, 'lon': 139.97732}}, {'zip': '278-0004', 'city': 'Noda', 'state': 'Chiba', 'country': 'Japan', 'facility': 'Kobari General Clinic', 'geoPoint': {'lat': 35.94897, 'lon': 139.86793}}, {'zip': '721-0927', 'city': 'Fukuyama-shi', 'state': 'Hiroshima', 'country': 'Japan', 'facility': 'Nippon Kokan Fukuyama Hospital'}, {'zip': '078-8234', 'city': 'Asahikawa', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Yamagata Naika Clinic', 'geoPoint': {'lat': 43.77063, 'lon': 142.36489}}, {'zip': '066-0032', 'city': 'Chitose', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Hasegawa Medical Clinic', 'geoPoint': {'lat': 42.81944, 'lon': 141.65222}}, {'zip': '060-0001', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Yuri Ono Clinic', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '060-0062', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Manda Memorial Hospital', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '063-0826', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Miyanosawa Clinic of Internal Medicine and Cardiology', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '670-0837', 'city': 'Himeji', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Takabe Diabetes Clinic', 'geoPoint': {'lat': 34.81667, 'lon': 134.7}}, {'zip': '310-0826', 'city': 'Mito', 'state': 'Ibaraki', 'country': 'Japan', 'facility': 'Nakamoto Internal Medicine Clinic', 'geoPoint': {'lat': 36.35, 'lon': 140.45}}, {'zip': '311-0113', 'city': 'Naka', 'state': 'Ibaraki', 'country': 'Japan', 'facility': 'Nakakinen clinic', 'geoPoint': {'lat': 36.05, 'lon': 140.16667}}, {'zip': '311-0133', 'city': 'Naka', 'state': 'Ibaraki', 'country': 'Japan', 'facility': 'Nishiyamadou Keiwa Hospital', 'geoPoint': {'lat': 36.05, 'lon': 140.16667}}, {'zip': '253-0044', 'city': 'Chigasaki', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Hayashi Diabetes Internal Medicine Clinic', 'geoPoint': {'lat': 35.33638, 'lon': 139.40434}}, {'zip': '247-0055', 'city': 'Kamakura', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Shonan Takai Clinic', 'geoPoint': {'lat': 35.31085, 'lon': 139.54698}}, {'zip': '247-0056', 'city': 'Kamakura-shi', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Takai Internal Medicine Clinic'}, {'zip': '252-0303', 'city': 'Sagamihara', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Yamagishi Clinic Sagamiono', 'geoPoint': {'lat': 35.56707, 'lon': 139.24167}}, {'zip': '242-0004', 'city': 'Yamato-shi', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic'}, {'zip': '989-2451', 'city': 'Iwanuma', 'state': 'Miyagi', 'country': 'Japan', 'facility': 'Seiryo Internal Medicine', 'geoPoint': {'lat': 38.10472, 'lon': 140.85944}}, {'zip': '399-0036', 'city': 'Matsumoto', 'state': 'Nagano', 'country': 'Japan', 'facility': 'Gibo Hepatology Clinic', 'geoPoint': {'lat': 36.23333, 'lon': 137.96667}}, {'zip': '582-0005', 'city': 'Kashihara', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Shiraiwa Medical Clinic', 'geoPoint': {'lat': 34.58333, 'lon': 135.61667}}, {'zip': '565-0853', 'city': 'Suita-shi', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Medical Corporation Heishinkai OCROM Clinic'}, {'zip': '340-0034', 'city': 'Sōka', 'state': 'Saitama', 'country': 'Japan', 'facility': 'Sugiura Internal Medicine Clinic', 'geoPoint': {'lat': 35.83643, 'lon': 139.79957}}, {'zip': '120-0011', 'city': 'Adachi-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Seiwa Clinic'}, {'zip': '103-0027', 'city': 'Chuo-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Tokyo-Eki Center-building Clinic'}, {'zip': '103-0028', 'city': 'Chuo-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Medical Corporation Chiseikai Tokyo Center Clinic'}, {'zip': '104-0031', 'city': 'Chuo-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Fukuwa Clinic'}, {'zip': '192-0083', 'city': 'Hachiōji', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Hachioji Diabetes Clinic', 'geoPoint': {'lat': 35.65583, 'lon': 139.32389}}, {'zip': '192-0918', 'city': 'Hachiōji', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Minamino Cardiovascular Hospital', 'geoPoint': {'lat': 35.65583, 'lon': 139.32389}}, {'zip': '153-0053', 'city': 'Meguro-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Yutenji Medical Clinic'}, {'zip': '181-0013', 'city': 'Mitaka', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Kanno Naika', 'geoPoint': {'lat': 35.68361, 'lon': 139.56002}}, {'zip': '160-0008', 'city': 'Shinjuku-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Heishinkai Medical Group ToCROM Clinic'}, {'zip': '173-0004', 'city': 'tabashi City', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Nomura Clinic', 'geoPoint': {'lat': 35.74893, 'lon': 139.71497}}, {'zip': '810-0006', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Futata Tetsuhiro Clinic', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '861-8039', 'city': 'Kumamoto', 'country': 'Japan', 'facility': 'Yoshimura Clinic', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'zip': '862-0976', 'city': 'Kumamoto', 'country': 'Japan', 'facility': 'Jinnouchi Hospital', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'zip': '880-0034', 'city': 'Miyazaki', 'country': 'Japan', 'facility': 'Heiwadai Hospital', 'geoPoint': {'lat': 31.91667, 'lon': 131.41667}}, {'zip': '380-0802', 'city': 'Nagano', 'country': 'Japan', 'facility': 'Ota Diabetes Internal Medicine Clinic', 'geoPoint': {'lat': 36.65, 'lon': 138.18333}}, {'zip': '530-0001', 'city': 'Osaka', 'country': 'Japan', 'facility': 'AMC Nishiumeda Clinic', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '538-0044', 'city': 'Osaka', 'country': 'Japan', 'facility': 'Kitada Clinic', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '545-8586', 'city': 'Osaka', 'country': 'Japan', 'facility': 'Osaka Metropolitan Univ Hosp', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '559-0011', 'city': 'Osaka', 'country': 'Japan', 'facility': 'Nanko Clinic', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '870-0039', 'city': 'Ōita', 'country': 'Japan', 'facility': 'Abe Clinic', 'geoPoint': {'lat': 33.23333, 'lon': 131.6}}], '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://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'}}}}