Ignite Creation Date:
2025-12-24 @ 3:19 PM
Ignite Modification Date:
2025-12-29 @ 12:55 AM
Study NCT ID:
NCT01697592
Status:
COMPLETED
Last Update Posted:
2018-09-10
First Post:
2012-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Omarigliptin (MK-3102) Clinical Trial - Add-on to Oral Antihyperglycemic Agent Study in Japanese Participants With Type 2 Diabetes Mellitus (MK-3102-015)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Japan']}, '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': 'C587539', 'term': '2-(2,5-difluorophenyl)-5-(2-(methylsulfonyl)-2,6-dihydropyrrolo(3,4-c)pyrazol-5(4H)-yl)tetrahydro-2H-pyran-3-amine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'The sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])', 'description': 'The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.', 'eventGroups': [{'id': 'EG000', 'title': 'Omarigliptin 25 mg/SU (Phase A)', 'description': 'Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.', 'otherNumAtRisk': 126, 'otherNumAffected': 33, 'seriousNumAtRisk': 126, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Omarigliptin 25 mg/Gln (Phase A)', 'description': 'Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.', 'otherNumAtRisk': 65, 'otherNumAffected': 19, 'seriousNumAtRisk': 65, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Omarigliptin 25 mg/BG (Phase A)', 'description': 'Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.', 'otherNumAtRisk': 66, 'otherNumAffected': 22, 'seriousNumAtRisk': 66, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Omarigliptin 25 mg/TZD (Phase A)', 'description': 'Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.', 'otherNumAtRisk': 65, 'otherNumAffected': 18, 'seriousNumAtRisk': 65, 'seriousNumAffected': 4}, {'id': 'EG004', 'title': 'Omarigliptin 25 mg/α-GI (Phase A)', 'description': 'Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.', 'otherNumAtRisk': 67, 'otherNumAffected': 19, 'seriousNumAtRisk': 67, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Placebo/ABM (Phase A)', 'description': 'Placebo to omargliptin administered orally once weekly for 24 weeks during Phase A. Participants continued any pre-study basal medication (ABM)throughout the duration of the study.', 'otherNumAtRisk': 196, 'otherNumAffected': 62, 'seriousNumAtRisk': 196, 'seriousNumAffected': 4}, {'id': 'EG006', 'title': 'Omarigliptin 25 mg/SU (Phase A+B)', 'description': 'Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of SU throughout the duration of the study.', 'otherNumAtRisk': 126, 'otherNumAffected': 58, 'seriousNumAtRisk': 126, 'seriousNumAffected': 6}, {'id': 'EG007', 'title': 'Omarigliptin 25 mg/Gln (Phase A+B)', 'description': 'Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of Gln throughout the duration of the study.', 'otherNumAtRisk': 65, 'otherNumAffected': 29, 'seriousNumAtRisk': 65, 'seriousNumAffected': 3}, {'id': 'EG008', 'title': 'Omarigliptin 25 mg/BG (Phase A+B)', 'description': 'Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of BG throughout the duration of the study.', 'otherNumAtRisk': 66, 'otherNumAffected': 33, 'seriousNumAtRisk': 66, 'seriousNumAffected': 2}, {'id': 'EG009', 'title': 'Omarigliptin 25 mg/TZD (Phase A+B)', 'description': 'Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of TZD throughout the duration of the study.', 'otherNumAtRisk': 65, 'otherNumAffected': 30, 'seriousNumAtRisk': 65, 'seriousNumAffected': 4}, {'id': 'EG010', 'title': 'Omarigliptin 25 mg/α-GI (Phase A+B)', 'description': 'Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of α-GI throughout the duration of the study.', 'otherNumAtRisk': 67, 'otherNumAffected': 26, 'seriousNumAtRisk': 67, 'seriousNumAffected': 1}, {'id': 'EG011', 'title': 'Omarigliptin 25mg/ABM (Phase B)', 'description': 'Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo.\n\nParticipants continued any prestudy basal medications throughout the duration of the study.', 'otherNumAtRisk': 191, 'otherNumAffected': 60, 'seriousNumAtRisk': 191, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 196, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 126, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 66, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 191, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 17, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG004', 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65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 196, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 126, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG007', 'numAtRisk': 65, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 66, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 191, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 196, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 126, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG007', 'numAtRisk': 65, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG008', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 191, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 196, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 126, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG007', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 67, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG011', 'numAtRisk': 191, 'numEvents': 10, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 196, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 126, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 65, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG010', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 65, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG008', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 65, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG010', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 196, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 126, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG007', 'numAtRisk': 65, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG008', 'numAtRisk': 66, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 65, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG010', 'numAtRisk': 67, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG011', 'numAtRisk': 191, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 126, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 65, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG010', 'numAtRisk': 67, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG011', 'numAtRisk': 191, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'seriousEvents': [{'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Macular hole', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Colitis ischaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, 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'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue During Phase A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}, {'value': '67', 'groupId': 'OG004'}, {'value': '63', 'groupId': 'OG005'}, {'value': '34', 'groupId': 'OG006'}, {'value': '33', 'groupId': 'OG007'}, {'value': '34', 'groupId': 'OG008'}, {'value': '32', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Omarigliptin 25 mg/SU (Phase A)', 'description': 'Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.'}, {'id': 'OG001', 'title': 'Omarigliptin 25 mg/Gln (Phase A)', 'description': 'Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.'}, {'id': 'OG002', 'title': 'Omarigliptin 25 mg/BG (Phase A)', 'description': 'Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.'}, {'id': 'OG003', 'title': 'Omarigliptin 25 mg/TZD (Phase A)', 'description': 'Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.'}, {'id': 'OG004', 'title': 'Omarigliptin 25 mg/α-GI (Phase A)', 'description': 'Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.'}, {'id': 'OG005', 'title': 'Placebo/SU (Phase A)', 'description': 'Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.'}, {'id': 'OG006', 'title': 'Placebo/Gln. (Phase A)', 'description': 'Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.'}, {'id': 'OG007', 'title': 'Placebo/BG (Phase A)', 'description': 'Placebo to Omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.'}, {'id': 'OG008', 'title': 'Placebo/TZD (Phase A)', 'description': 'Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.'}, {'id': 'OG009', 'title': 'Placebo/α-GI (Phase A)', 'description': 'Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '59.5', 'groupId': 'OG000'}, {'value': '53.8', 'groupId': 'OG001'}, {'value': '54.5', 'groupId': 'OG002'}, {'value': '60.0', 'groupId': 'OG003'}, {'value': '50.7', 'groupId': 'OG004'}, {'value': '60.3', 'groupId': 'OG005'}, {'value': '52.9', 'groupId': 'OG006'}, {'value': '63.6', 'groupId': 'OG007'}, {'value': '52.9', 'groupId': 'OG008'}, {'value': '53.1', 'groupId': 'OG009'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 weeks', 'description': 'An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. Glycemic rescue criteria were: fasting plasma glucose (FPG) of \\>240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG \\>200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Subjects as Treated (ASaT) population, defined as all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data using the ASaT population.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue During the Overall Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}, {'value': '67', 'groupId': 'OG004'}, {'value': '62', 'groupId': 'OG005'}, {'value': '32', 'groupId': 'OG006'}, {'value': '33', 'groupId': 'OG007'}, {'value': '34', 'groupId': 'OG008'}, {'value': '30', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Omarigliptin 25 mg/SU (Phase A+B)', 'description': 'Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of SU throughout the duration of the study.'}, {'id': 'OG001', 'title': 'Omarigliptin 25 mg/Gln (Phase A+B)', 'description': 'Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of Gln throughout the duration of the study.'}, {'id': 'OG002', 'title': 'Omarigliptin 25 mg/BG (Phase A+B)', 'description': 'Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of BG throughout the duration of the study.'}, {'id': 'OG003', 'title': 'Omarigliptin 25 mg/TZD (Phase A+B)', 'description': 'Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of TZD throughout the duration of the study.'}, {'id': 'OG004', 'title': 'Omarigliptin 25 mg/α-GI (Phase A+B)', 'description': 'Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of α-GI throughout the duration of the study.'}, {'id': 'OG005', 'title': 'Omarigliptin 25mg/SU (Phase B)', 'description': 'Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo.\n\nParticipants continued prestudy basal medication of SU throughout the duration of the study.'}, {'id': 'OG006', 'title': 'Omarigliptin 25mg/Gln (Phase B)', 'description': 'Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo.\n\nParticipants continued pre-study basal medication of Gln throughout the duration of the study.'}, {'id': 'OG007', 'title': 'Omarigliptin 25mg/BG (Phase B)', 'description': 'Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo. Participants continued pre-study basal medication of BG throughout the duration of the study.'}, {'id': 'OG008', 'title': 'Omarigliptin 25mg/TZD (Phase B)', 'description': 'Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo. Participants continued pre-study basal medication of TZD throughout the duration of the study.'}, {'id': 'OG009', 'title': 'Omarigliptin 25mg/α-GI (Phase B)', 'description': 'Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo. Participants continued pre-study basal medication of α-GI throughout the duration of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '76.2', 'groupId': 'OG000'}, {'value': '75.4', 'groupId': 'OG001'}, {'value': '80.3', 'groupId': 'OG002'}, {'value': '84.6', 'groupId': 'OG003'}, {'value': '68.7', 'groupId': 'OG004'}, {'value': '56.5', 'groupId': 'OG005'}, {'value': '59.4', 'groupId': 'OG006'}, {'value': '66.7', 'groupId': 'OG007'}, {'value': '58.8', 'groupId': 'OG008'}, {'value': '53.3', 'groupId': 'OG009'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 52 weeks', 'description': 'An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. Glycemic rescue criteria were: fasting plasma glucose (FPG) of \\>240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG \\>200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue). These results represent the accrual of events over different treatment intervals: 52 weeks, Omarigliptin (Phase A+B) group, defined as the double-blind period and open-label extension period versus 28 weeks for the placebo switching to Omarigliptin group defined as the open-label extension period only.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ASaT population was all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data. Data was unavailable for 5 participants who discontinued from the study in the placebo arm in Phase A.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During Phase A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}, {'value': '67', 'groupId': 'OG004'}, {'value': '63', 'groupId': 'OG005'}, {'value': '34', 'groupId': 'OG006'}, {'value': '33', 'groupId': 'OG007'}, {'value': '34', 'groupId': 'OG008'}, {'value': '32', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Omarigliptin 25 mg/SU (Phase A)', 'description': 'Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.'}, {'id': 'OG001', 'title': 'Omarigliptin 25 mg/Gln (Phase A)', 'description': 'Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.'}, {'id': 'OG002', 'title': 'Omarigliptin 25 mg/BG (Phase A)', 'description': 'Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.'}, {'id': 'OG003', 'title': 'Omarigliptin 25 mg/TZD (Phase A)', 'description': 'Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.'}, {'id': 'OG004', 'title': 'Omarigliptin 25 mg/α-GI (Phase A)', 'description': 'Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.'}, {'id': 'OG005', 'title': 'Placebo/SU (Phase A)', 'description': 'Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.'}, {'id': 'OG006', 'title': 'Placebo/Gln. (Phase A)', 'description': 'Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.'}, {'id': 'OG007', 'title': 'Placebo/BG (Phase A)', 'description': 'Placebo to Omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.'}, {'id': 'OG008', 'title': 'Placebo/TZD (Phase A)', 'description': 'Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.'}, {'id': 'OG009', 'title': 'Placebo/α-GI (Phase A)', 'description': 'Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3.1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3.1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2.9', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '3.1', 'groupId': 'OG009'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 weeks', 'description': 'An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ASaT population was defined as all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data using the ASaT population.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During the Overall Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}, {'value': '67', 'groupId': 'OG004'}, {'value': '62', 'groupId': 'OG005'}, {'value': '32', 'groupId': 'OG006'}, {'value': '33', 'groupId': 'OG007'}, {'value': '34', 'groupId': 'OG008'}, {'value': '30', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Omarigliptin 25 mg/SU (Phase A+B)', 'description': 'Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of SU throughout the duration of the study.'}, {'id': 'OG001', 'title': 'Omarigliptin 25 mg/Gln (Phase A)', 'description': 'Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.'}, {'id': 'OG002', 'title': 'Omarigliptin 25 mg/BG (Phase A+B)', 'description': 'Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of BG throughout the duration of the study.'}, {'id': 'OG003', 'title': 'Omarigliptin 25 mg/TZD (Phase A+B)', 'description': 'Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of TZD throughout the duration of the study.'}, {'id': 'OG004', 'title': 'Omarigliptin 25 mg/α-GI (Phase A+B)', 'description': 'Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of α-GI throughout the duration of the study.'}, {'id': 'OG005', 'title': 'Omarigliptin 25mg/SU (Phase B)', 'description': 'Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo.\n\nParticipants continued prestudy basal medication of SU throughout the duration of the study.'}, {'id': 'OG006', 'title': 'Omarigliptin 25mg/Gln (Phase B)', 'description': 'Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo.\n\nParticipants continued pre-study basal medication of Gln throughout the duration of the study.'}, {'id': 'OG007', 'title': 'Omarigliptin 25mg/BG (Phase B)', 'description': 'Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo. Participants continued pre-study basal medication of BG. throughout the duration of the study.'}, {'id': 'OG008', 'title': 'Omarigliptin 25mg/TZD (Phase B)', 'description': 'Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo. Participants continued pre-study basal medication of TZD throughout the duration of the study.'}, {'id': 'OG009', 'title': 'Omarigliptin 25mg/α-GI (Phase B)', 'description': 'Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo. Participants continued pre-study basal medication of α-GI throughout the duration of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000'}, {'value': '4.6', 'groupId': 'OG001'}, {'value': '1.5', 'groupId': 'OG002'}, {'value': '6.2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1.6', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '2.9', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 52 weeks', 'description': 'An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. Glycemic rescue criteria were: fasting plasma glucose (FPG) of \\>240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG \\>200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue). These results represent the accrual of events over different treatment intervals: 52 weeks, Omarigliptin (Phase A+B) group, defined as the double-blind period and open-label extension period versus 28 weeks for the placebo switching to Omarigliptin group defined as the open-label extension period only.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ASaT population was all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data. Data was unavailable for 5 participants who discontinued from the study in the placebo arm in Phase A.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}, {'value': '67', 'groupId': 'OG004'}, {'value': '63', 'groupId': 'OG005'}, {'value': '34', 'groupId': 'OG006'}, {'value': '33', 'groupId': 'OG007'}, {'value': '34', 'groupId': 'OG008'}, {'value': '32', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Omarigliptin 25 mg/SU (Phase A)', 'description': 'Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.'}, {'id': 'OG001', 'title': 'Omarigliptin 25 mg/Gln (Phase A)', 'description': 'Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.'}, {'id': 'OG002', 'title': 'Omarigliptin 25 mg/BG (Phase A)', 'description': 'Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.'}, {'id': 'OG003', 'title': 'Omarigliptin 25 mg/TZD (Phase A)', 'description': 'Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.'}, {'id': 'OG004', 'title': 'Omarigliptin 25 mg/α-GI (Phase A)', 'description': 'Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.'}, {'id': 'OG005', 'title': 'Placebo/SU (Phase A)', 'description': 'Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.'}, {'id': 'OG006', 'title': 'Placebo/Gln. (Phase A)', 'description': 'Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln. throughout the duration of the study.'}, {'id': 'OG007', 'title': 'Placebo/BG (Phase A)', 'description': 'Placebo to Omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.'}, {'id': 'OG008', 'title': 'Placebo/TZD (Phase A)', 'description': 'Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.'}, {'id': 'OG009', 'title': 'Placebo/α-GI (Phase A)', 'description': 'Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.84', 'groupId': 'OG000', 'lowerLimit': '-0.94', 'upperLimit': '-0.73'}, {'value': '-0.68', 'groupId': 'OG001', 'lowerLimit': '-0.89', 'upperLimit': '-0.48'}, {'value': '-0.94', 'groupId': 'OG002', 'lowerLimit': '-1.10', 'upperLimit': '-0.78'}, {'value': '-0.88', 'groupId': 'OG003', 'lowerLimit': '-1.04', 'upperLimit': '-0.73'}, {'value': '-0.74', 'groupId': 'OG004', 'lowerLimit': '-0.89', 'upperLimit': '-0.59'}, {'value': '0.09', 'groupId': 'OG005', 'lowerLimit': '-0.06', 'upperLimit': '0.24'}, {'value': '0.30', 'groupId': 'OG006', 'lowerLimit': '-0.04', 'upperLimit': '0.64'}, {'value': '-0.02', 'groupId': 'OG007', 'lowerLimit': '-0.35', 'upperLimit': '0.31'}, {'value': '0.28', 'groupId': 'OG008', 'lowerLimit': '0.03', 'upperLimit': '0.53'}, {'value': '0.06', 'groupId': 'OG009', 'lowerLimit': '-0.16', 'upperLimit': '0.28'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG005'], 'paramType': 'Difference in the least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.93', 'ciLowerLimit': '-1.10', 'ciUpperLimit': '-0.75', 'statisticalMethod': 'Constrained longitudinal data analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Constrained longitudinal data analysis with terms for treatment, basal AHA medication, prior AHA therapy status except for basal medication, and time.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG006'], 'paramType': 'Difference in the least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.98', 'ciLowerLimit': '-1.37', 'ciUpperLimit': '-0.60', 'statisticalMethod': 'Constrained longitudinal data analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Constrained longitudinal data analysis with terms for treatment, basal AHA medication, prior AHA therapy status except for basal medication, and time.'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG007'], 'paramType': 'Difference in the least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.92', 'ciLowerLimit': '-1.29', 'ciUpperLimit': '-0.56', 'statisticalMethod': 'Constrained longitudinal data analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Constrained longitudinal data analysis with terms for treatment, basal AHA medication, prior AHA therapy status except for basal medication, and time.'}, {'pValue': '<0.001', 'groupIds': ['OG003', 'OG008'], 'paramType': 'Difference in the least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.16', 'ciLowerLimit': '-1.45', 'ciUpperLimit': '-0.88', 'statisticalMethod': 'Constrained longitudinal data analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Constrained longitudinal data analysis with terms for treatment, basal AHA medication, prior AHA therapy status except for basal medication, and time.'}, {'pValue': '<0.001', 'groupIds': ['OG004', 'OG009'], 'paramType': 'Difference in the least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.80', 'ciLowerLimit': '-1.06', 'ciUpperLimit': '-0.54', 'statisticalMethod': 'Constrained longitudinal data analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Constrained longitudinal data analysis with terms for treatment, basal AHA medication, prior AHA therapy status except for basal medication, and time.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 24 HbA1c minus the Week 0 HbA1c.', 'unitOfMeasure': 'Percent HbA1C', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS), comprised of all participants who received at least one study drug and have a baseline or post-randomization measurement.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Omarigliptin 25 mg/Sulfonylureas (SU) (Phase A+B)', 'description': 'Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of SU throughout the duration of the study.'}, {'id': 'FG001', 'title': 'Omarigliptin 25 mg/Glinides (Gln) (Phase A+B)', 'description': 'Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of Gln throughout the duration of the study.'}, {'id': 'FG002', 'title': 'Omarigliptin 25 mg/Biguanides (BG) (Phase A+B)', 'description': 'Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of BG throughout the duration of the study.'}, {'id': 'FG003', 'title': 'Omarigliptin 25 mg/Thiazolidinediones (TZD) (Phase A+B)', 'description': 'Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of TZD throughout the duration of the study.'}, {'id': 'FG004', 'title': 'Omarigliptin 25 mg/α-GI (Phase A+B)', 'description': 'Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of α-glucosidase (α-GI) throughout the duration of the study.'}, {'id': 'FG005', 'title': 'Placebo/SU (Phase A) Switching to Omari. 25 mg/SU (Phase B)', 'description': 'Placebo to omarigliptin (omari.)administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of SU throughout the duration of the study.'}, {'id': 'FG006', 'title': 'Placebo/Gln. (Phase A) Switching to Omari. 25 mg/Gln (Phase B)', 'description': 'Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of Gln throughout the duration of the study.'}, {'id': 'FG007', 'title': 'Placebo/BG (Phase A) Switching to Omari. 25 mg/BG (Phase B)', 'description': 'Placebo to Omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of BG. throughout the duration of the study.'}, {'id': 'FG008', 'title': 'Placebo/TZD (Phase A) Switching to Omari. 25 mg/TZ (Phase B)', 'description': 'Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of TZD throughout the duration of the study.'}, {'id': 'FG009', 'title': 'Placebo/α-GI (Phase A) Switching to Omari. 25 mg/α-GI (Ph. B)', 'description': 'Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of α-GI throughout the duration of the study.'}], 'periods': [{'title': 'Phase A (Up to 24 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '126'}, {'groupId': 'FG001', 'numSubjects': '65'}, {'groupId': 'FG002', 'numSubjects': '66'}, {'groupId': 'FG003', 'numSubjects': '65'}, {'groupId': 'FG004', 'numSubjects': '67'}, {'groupId': 'FG005', 'numSubjects': '63'}, {'groupId': 'FG006', 'numSubjects': '34'}, {'groupId': 'FG007', 'numSubjects': '33'}, {'groupId': 'FG008', 'numSubjects': '34'}, {'groupId': 'FG009', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '123'}, {'groupId': 'FG001', 'numSubjects': '62'}, {'groupId': 'FG002', 'numSubjects': '65'}, {'groupId': 'FG003', 'numSubjects': '63'}, {'groupId': 'FG004', 'numSubjects': '67'}, {'groupId': 'FG005', 'numSubjects': '62'}, {'groupId': 'FG006', 'numSubjects': '32'}, {'groupId': 'FG007', 'numSubjects': '33'}, {'groupId': 'FG008', 'numSubjects': '34'}, {'groupId': 'FG009', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}]}]}, {'title': 'Phase B (Week 25 to Week 52)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '123'}, {'groupId': 'FG001', 'numSubjects': '62'}, {'groupId': 'FG002', 'numSubjects': '65'}, {'groupId': 'FG003', 'numSubjects': '63'}, {'groupId': 'FG004', 'numSubjects': '67'}, {'groupId': 'FG005', 'numSubjects': '62'}, {'groupId': 'FG006', 'numSubjects': '32'}, {'groupId': 'FG007', 'numSubjects': '33'}, {'groupId': 'FG008', 'numSubjects': '34'}, {'groupId': 'FG009', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '118'}, {'groupId': 'FG001', 'numSubjects': '61'}, {'groupId': 'FG002', 'numSubjects': '64'}, {'groupId': 'FG003', 'numSubjects': '60'}, {'groupId': 'FG004', 'numSubjects': '67'}, {'groupId': 'FG005', 'numSubjects': '60'}, {'groupId': 'FG006', 'numSubjects': '31'}, {'groupId': 'FG007', 'numSubjects': '32'}, {'groupId': 'FG008', 'numSubjects': '32'}, {'groupId': 'FG009', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Sixty-seven sites in Japan received IRB approval and were shipped clinical supplies in this study and randomized at least one participant. A total of 772 participants were screened of which 187 participants were excluded. The most common reason for participants not being randomized was screen failure (meeting exclusionary laboratory values).', 'preAssignmentDetails': 'In Phase A, participants were randomized to receive either omarigliptin (MK-3102) 25 mg once weekly or placebo for 24 weeks in a blinded manner. In Phase B, all participants received open-label omarigliptin 25 mg once weekly for 28 weeks.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}, {'value': '67', 'groupId': 'BG004'}, {'value': '63', 'groupId': 'BG005'}, {'value': '34', 'groupId': 'BG006'}, {'value': '33', 'groupId': 'BG007'}, {'value': '34', 'groupId': 'BG008'}, {'value': '32', 'groupId': 'BG009'}, {'value': '585', 'groupId': 'BG010'}]}], 'groups': [{'id': 'BG000', 'title': 'Omarigliptin 25 mg/SU (Phase A+B)', 'description': 'Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of SU throughout the duration of the study.'}, {'id': 'BG001', 'title': 'Omarigliptin 25 mg/Gln (Phase A+B)', 'description': 'Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of Gln throughout the duration of the study.'}, {'id': 'BG002', 'title': 'Omarigliptin 25 mg/BG (Phase A+B)', 'description': 'Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of BG throughout the duration of the study.'}, {'id': 'BG003', 'title': 'Omarigliptin 25 mg/TZD (Phase A+B)', 'description': 'Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of TZD throughout the duration of the study.'}, {'id': 'BG004', 'title': 'Omarigliptin 25 mg/α-GI (Phase A+B)', 'description': 'Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of α-GI throughout the duration of the study.'}, {'id': 'BG005', 'title': 'Placebo/SU (Phase A) Switching to Omari. 25 mg/SU (Phase B)', 'description': 'Placebo to omarigliptin (omari.)administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of SU throughout the duration of the study.'}, {'id': 'BG006', 'title': 'Placebo/Gln (Phase A) Switching to Omari. 25 mg/Gln (Ph. B)', 'description': 'Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of Gln throughout the duration of the study.'}, {'id': 'BG007', 'title': 'Placebo/BG (Phase A) Switching to Omari. 25 mg/BG (Phase B)', 'description': 'Placebo to Omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of BG throughout the duration of the study.'}, {'id': 'BG008', 'title': 'Placebo/TZD (Phase A) Switching to Omari. 25 mg/TZD (Phase B)', 'description': 'Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of TZD throughout the duration of the study.'}, {'id': 'BG009', 'title': 'Placebo/α-GI (Phase A) Switching to Omari. 25 mg/α-GI (Ph. B)', 'description': 'Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of α-GI throughout the duration of the study.'}, {'id': 'BG010', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63', 'spread': '9', 'groupId': 'BG000'}, {'value': '59', 'spread': '11', 'groupId': 'BG001'}, {'value': '59', 'spread': '9', 'groupId': 'BG002'}, {'value': '61', 'spread': '10', 'groupId': 'BG003'}, {'value': '61', 'spread': '11', 'groupId': 'BG004'}, {'value': '63', 'spread': '11', 'groupId': 'BG005'}, {'value': '61', 'spread': '10', 'groupId': 'BG006'}, {'value': '57', 'spread': '9', 'groupId': 'BG007'}, {'value': '61', 'spread': '9', 'groupId': 'BG008'}, {'value': '61', 'spread': '11', 'groupId': 'BG009'}, {'value': '61', 'spread': '10', 'groupId': 'BG010'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '18', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '10', 'groupId': 'BG007'}, {'value': '7', 'groupId': 'BG008'}, {'value': '9', 'groupId': 'BG009'}, {'value': '169', 'groupId': 'BG010'}]}, {'title': 'Male', 'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '46', 'groupId': 'BG004'}, {'value': '45', 'groupId': 'BG005'}, {'value': '27', 'groupId': 'BG006'}, {'value': '23', 'groupId': 'BG007'}, {'value': '27', 'groupId': 'BG008'}, {'value': '23', 'groupId': 'BG009'}, {'value': '416', 'groupId': 'BG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 585}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2014-05-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-08', 'studyFirstSubmitDate': '2012-09-28', 'resultsFirstSubmitDate': '2015-09-29', 'studyFirstSubmitQcDate': '2012-09-28', 'lastUpdatePostDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-09-29', 'studyFirstPostDateStruct': {'date': '2012-10-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue During Phase A', 'timeFrame': 'Up to 24 weeks', 'description': 'An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. Glycemic rescue criteria were: fasting plasma glucose (FPG) of \\>240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG \\>200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue).'}, {'measure': 'Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue During the Overall Study', 'timeFrame': 'Up to 52 weeks', 'description': 'An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. Glycemic rescue criteria were: fasting plasma glucose (FPG) of \\>240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG \\>200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue). These results represent the accrual of events over different treatment intervals: 52 weeks, Omarigliptin (Phase A+B) group, defined as the double-blind period and open-label extension period versus 28 weeks for the placebo switching to Omarigliptin group defined as the open-label extension period only.'}, {'measure': 'Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During Phase A', 'timeFrame': 'Up to 24 weeks', 'description': 'An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.'}, {'measure': 'Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During the Overall Study', 'timeFrame': 'Up to 52 weeks', 'description': 'An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. Glycemic rescue criteria were: fasting plasma glucose (FPG) of \\>240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG \\>200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue). These results represent the accrual of events over different treatment intervals: 52 weeks, Omarigliptin (Phase A+B) group, defined as the double-blind period and open-label extension period versus 28 weeks for the placebo switching to Omarigliptin group defined as the open-label extension period only.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 24 HbA1c minus the Week 0 HbA1c.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'availIpds': [{'url': 'http://www.merck.com/clinical-trials/study.html?id=3102-015&kw=3102-015&tab=access', 'type': 'CSR Snyopsis'}], 'references': [{'pmid': '28589493', 'type': 'RESULT', 'citation': "Gantz I, Okamoto T, Ito Y, Sato A, Okuyama K, O'Neill EA, Engel SS, Lai E; Omarigliptin Study 015 Group. A Randomized, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Adding Omarigliptin to Antihyperglycemic Therapies in Japanese Patients with Type 2 Diabetes and Inadequate Glycemic Control. Diabetes Ther. 2017 Aug;8(4):793-810. doi: 10.1007/s13300-017-0270-7. Epub 2017 Jun 6."}]}, 'descriptionModule': {'briefSummary': 'This study will examine the safety and efficacy of the addition of omarigliptin in Japanese participants with type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy and oral antihyperglycemic agent monotherapy.', 'detailedDescription': 'The treatment period is composed of a 24-week double-blind period (Phase A) and a 28-week open-label period (Phase B). During Phase A, participants will received either omarigliptin 25 mg or a matching placebo. During Phase, B all participants will receive omarigliptin 25 mg. All participants will remain on a stable dose and administration of a single oral antihyperglycemic basal medication.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has type 2 diabetes mellitus\n* Has inadequate glycemic control on diet/exercise therapy and oral antihyperglycemic agent monotherapy\n\nExclusion Criteria:\n\n* History of type 1 diabetes mellitus or a history of ketoacidosis\n* History of any of the following medications: Thiazolidinediones (TZD) (for participants whose basal medication is not TZD) and/or insulin within 12 weeks prior to study participation, omarigliptin anytime'}, 'identificationModule': {'nctId': 'NCT01697592', 'briefTitle': 'Omarigliptin (MK-3102) Clinical Trial - Add-on to Oral Antihyperglycemic Agent Study in Japanese Participants With Type 2 Diabetes Mellitus (MK-3102-015)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase III, Multicenter, Randomized, Placebo-controlled, Parallel-group, Double-blinded Study and Subsequent Open-label, Extension Study to Assess the Safety and Efficacy of Addition of MK-3102 in Japanese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy and Oral Antihyperglycemic Agent Monotherapy', 'orgStudyIdInfo': {'id': '3102-015'}, 'secondaryIdInfos': [{'id': '132242', 'type': 'REGISTRY', 'domain': 'JAPIC-CTI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Omarigliptin 25 mg/Sulfonylureas (SUs) (Phase A+B)', 'description': 'Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of SUs throughout the duration of the study.', 'interventionNames': ['Drug: Omarigliptin']}, {'type': 'EXPERIMENTAL', 'label': 'Omarigliptin 25 mg/Glinides (Phase A+B)', 'description': 'Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of glinides throughout the duration of the study.', 'interventionNames': ['Drug: Omarigliptin']}, {'type': 'EXPERIMENTAL', 'label': 'Omarigliptin 25 mg/biguanides (BGs) (Phase A+B)', 'description': 'Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of BGs throughout the duration of the study.', 'interventionNames': ['Drug: Omarigliptin']}, {'type': 'EXPERIMENTAL', 'label': 'Omarigliptin 25 mg/Thiazolidinediones (TZDs) (Phase A+B)', 'description': 'Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of TZDs throughout the duration of the study.', 'interventionNames': ['Drug: Omarigliptin']}, {'type': 'EXPERIMENTAL', 'label': 'Omarigliptin 25 mg/α-GIs (Phase A+B)', 'description': 'Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of α-glucosidase (α-GIs) inhibitors throughout the duration of the study.', 'interventionNames': ['Drug: Omarigliptin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo/SUs (Phase A) → Omarigliptin 25 mg/SUs (Phase B)', 'description': 'Placebo matching omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg is administered once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of SUs throughout the duration of the study.', 'interventionNames': ['Drug: Omarigliptin', 'Drug: Matching placebo to omarigliptin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo/Glinides (Phase A) → Omarigliptin 25 mg/Gln. (Phase B)', 'description': 'Placebo matching omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg is administered once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of glinides throughout the duration of the study.', 'interventionNames': ['Drug: Omarigliptin', 'Drug: Matching placebo to omarigliptin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo/BGs (Phase A) → Omarigliptin 25 mg/BGs (Phase B)', 'description': 'Placebo matching omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg is administered once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of BGs throughout the duration of the study.', 'interventionNames': ['Drug: Omarigliptin', 'Drug: Matching placebo to omarigliptin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo/TZDs (Phase A) → Omarigliptin 25 mg/TZDs (Phase B)', 'description': 'Placebo matching omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg is administered once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of TZDs throughout the duration of the study.', 'interventionNames': ['Drug: Omarigliptin', 'Drug: Matching placebo to omarigliptin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo/α-GIs (Phase A) → Omarigliptin 25 mg/α-GIs (Phase B)', 'description': 'Placebo matching omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg is administered once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of α-GIs inhibitors throughout the duration of the study.', 'interventionNames': ['Drug: Omarigliptin', 'Drug: Matching placebo to omarigliptin']}], 'interventions': [{'name': 'Omarigliptin', 'type': 'DRUG', 'description': 'Omarigliptin (MK-3102) 25 mg capsule administered orally once weekly. Pre-study basal medications include: SUs (gliclazide, glibenclamide, or glimepiride); Glinides (nateglinide , mitiglinide, or repaglinide); BGs (metformin); TZDs (pioglitazone); and α-GIs (acarbose, voglibose, or miglitol).', 'armGroupLabels': ['Omarigliptin 25 mg/Glinides (Phase A+B)', 'Omarigliptin 25 mg/Sulfonylureas (SUs) (Phase A+B)', 'Omarigliptin 25 mg/Thiazolidinediones (TZDs) (Phase A+B)', 'Omarigliptin 25 mg/biguanides (BGs) (Phase A+B)', 'Omarigliptin 25 mg/α-GIs (Phase A+B)', 'Placebo/BGs (Phase A) → Omarigliptin 25 mg/BGs (Phase B)', 'Placebo/Glinides (Phase A) → Omarigliptin 25 mg/Gln. (Phase B)', 'Placebo/SUs (Phase A) → Omarigliptin 25 mg/SUs (Phase B)', 'Placebo/TZDs (Phase A) → Omarigliptin 25 mg/TZDs (Phase B)', 'Placebo/α-GIs (Phase A) → Omarigliptin 25 mg/α-GIs (Phase B)']}, {'name': 'Matching placebo to omarigliptin', 'type': 'DRUG', 'description': 'Matching placebo to omarigliptin 25 mg capsule administered orally once weekly. Pre-study basal medications include: SUs (gliclazide, glibenclamide, or glimepiride); Glinides (nateglinide , mitiglinide, or repaglinide); BGs (metformin); TZDs (pioglitazone); and α-GIs (acarbose, voglibose, or miglitol).', 'armGroupLabels': ['Placebo/BGs (Phase A) → Omarigliptin 25 mg/BGs (Phase B)', 'Placebo/Glinides (Phase A) → Omarigliptin 25 mg/Gln. (Phase B)', 'Placebo/SUs (Phase A) → Omarigliptin 25 mg/SUs (Phase B)', 'Placebo/TZDs (Phase A) → Omarigliptin 25 mg/TZDs (Phase B)', 'Placebo/α-GIs (Phase A) → Omarigliptin 25 mg/α-GIs (Phase B)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}