Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2026-03-29 @ 4:03 PM
Study NCT ID:
NCT01755156
Status:
COMPLETED
Last Update Posted:
2018-09-10
First Post:
2012-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Safety, Tolerability, and Efficacy of the Addition of Omarigliptin (MK-3102) to Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Therapy (MK-3102-024)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Bulgaria', 'Hungary', 'Poland', 'Romania', 'Russia', 'Slovakia', 'South Africa', 'Spain', 'United States']}, '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'}, {'id': 'C057619', 'term': 'glimepiride'}, {'id': 'D000069036', 'term': 'Insulin Glargine'}, {'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D049528', 'term': 'Insulin, Long-Acting'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, '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 study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 107 weeks (treatment period + 21-day follow-up)', 'description': 'APaT population consists of all randomized participants who took at least 1 dose of study drug. Serious adverse events (SAEs) include data after glycemic rescue; non-serious adverse events exclude data after glycemic rescue. The AEs reported in the (Phase A) → (Phase B) columns are a total of the AEs (SAEs) that occurred in Phases A and B.', 'eventGroups': [{'id': 'EG000', 'title': 'Omarigliptin (Phase A)', 'description': 'Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.', 'otherNumAtRisk': 201, 'otherNumAffected': 27, 'seriousNumAtRisk': 201, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Placebo to Omarigliptin (Phase A)', 'description': 'Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks.', 'otherNumAtRisk': 201, 'otherNumAffected': 17, 'seriousNumAtRisk': 201, 'seriousNumAffected': 10}, {'id': 'EG002', 'title': 'Omarigliptin (Phase A) → Omarigliptin (Phase B)', 'description': 'Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks.', 'otherNumAtRisk': 201, 'otherNumAffected': 53, 'seriousNumAtRisk': 201, 'seriousNumAffected': 12}, {'id': 'EG003', 'title': 'Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B)', 'description': 'Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks.', 'otherNumAtRisk': 201, 'otherNumAffected': 58, 'seriousNumAtRisk': 201, 'seriousNumAffected': 18}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 201, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1, 18.1'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 201, 'numEvents': 14, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1, 18.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 13, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 43, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 201, 'numEvents': 112, 'numAffected': 32}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1, 18.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 201, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1, 18.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 201, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1, 18.1'}], 'seriousEvents': [{'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1, 18.1'}, {'term': 'Atrioventricular block second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1, 18.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1, 18.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1, 18.1'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1, 18.1'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1, 18.1'}, {'term': 'Gastric polyps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1, 18.1'}, {'term': 'Pancreatic cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1, 18.1'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1, 18.1'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1, 18.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1, 18.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1, 18.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1, 18.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1, 18.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1, 18.1'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1, 18.1'}, {'term': 'Seroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1, 18.1'}, {'term': 'Tendon injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1, 18.1'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1, 18.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1, 18.1'}, {'term': 'Osteochondrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1, 18.1'}, {'term': 'Adenocarcinoma of colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1, 18.1'}, {'term': 'Bladder neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1, 18.1'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1, 18.1'}, {'term': 'Hepatocellular carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1, 18.1'}, {'term': 'Invasive ductal breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1, 18.1'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1, 18.1'}, {'term': 'Uterine haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1, 18.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1, 18.1'}, {'term': 'Peripheral venous disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1, 18.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Glycosylated Hemoglobin (A1C) at Week 24 (Phase A)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omarigliptin (Phase A)', 'description': 'Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo to Omarigliptin (Phase A)', 'description': 'Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.54', 'groupId': 'OG000', 'lowerLimit': '-0.69', 'upperLimit': '-0.40'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-0.14', 'upperLimit': '0.15'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.55', 'ciLowerLimit': '-0.75', 'ciUpperLimit': '-0.34', 'statisticalMethod': 'cLDA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on a cLDA method with a restriction of the same baseline mean.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'A1C is measured as a percent. Change from baseline in A1C at Week 24 was analyzed using a constrained longitudinal data analysis (cLDA) method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, time, and the interaction of time by treatment.', 'unitOfMeasure': 'Percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Experienced at Least One Adverse Event (Phase A+B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omarigliptin (Phase A) → Omarigliptin (Phase B)', 'description': 'Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks.'}, {'id': 'OG001', 'title': 'Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B)', 'description': 'Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '65.7', 'groupId': 'OG000'}, {'value': '65.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-8.8', 'ciUpperLimit': '9.8', 'estimateComment': 'Based on Miettinen \\& Nurminen method. The 95% CI was computed only for those endpoints with at least 4 participants having events in 1 or more treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 107 weeks', 'description': 'An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants as treated population included all participants who received at least one dose of study medication.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (Phase A+B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omarigliptin (Phase A) → Omarigliptin (Phase B)', 'description': 'Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks.'}, {'id': 'OG001', 'title': 'Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B)', 'description': 'Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}, {'value': '4.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.5', 'ciLowerLimit': '-6.6', 'ciUpperLimit': '1.1', 'estimateComment': 'Based on Miettinen \\& Nurminen method. The 95% CI was computed only for those endpoints with at least 4 participants having events in 1 or more treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 104 weeks', 'description': 'An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants as treated population included all participants who received at least one dose of study medication.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Experienced an Adverse Event Which Were Included Under the System Order Class of Investigations (Phase A+B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omarigliptin (Phase A) → Omarigliptin (Phase B)', 'description': 'Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks.'}, {'id': 'OG001', 'title': 'Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B)', 'description': 'Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.9', 'groupId': 'OG000'}, {'value': '17.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.5', 'ciLowerLimit': '-3.3', 'ciUpperLimit': '12.3', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 104 weeks', 'description': 'The following laboratory parameters were included: blood chemistry, hematology, electrocardiograms, lipids, body weight, and vital signs.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants as treated population included all participants who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24 (Phase A)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omarigliptin (Phase A)', 'description': 'Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo to Omarigliptin (Phase A)', 'description': 'Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-26.8', 'groupId': 'OG000', 'lowerLimit': '-34.8', 'upperLimit': '-18.7'}, {'value': '-12.2', 'groupId': 'OG001', 'lowerLimit': '-20.7', 'upperLimit': '-3.8'}]}]}], 'analyses': [{'pValue': '0.011', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.5', 'ciLowerLimit': '-25.6', 'ciUpperLimit': '-3.4', 'statisticalMethod': 'cLDA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on a cLDA method with a restriction of the same baseline mean.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'Change from baseline in 2-hour PMG at Week 24 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, time, and the interaction of time by treatment.', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Phase A)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omarigliptin (Phase A)', 'description': 'Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo to Omarigliptin (Phase A)', 'description': 'Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.7', 'groupId': 'OG000', 'lowerLimit': '-16.0', 'upperLimit': '-5.5'}, {'value': '-1.2', 'groupId': 'OG001', 'lowerLimit': '-6.6', 'upperLimit': '4.1'}]}]}], 'analyses': [{'pValue': '0.010', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.5', 'ciLowerLimit': '-16.7', 'ciUpperLimit': '-2.3', 'statisticalMethod': 'cLDA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on a cLDA method with a restriction of the same baseline mean.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'Change from baseline in FPG at Week 24 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, time, and the interaction of time by treatment.', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in A1C at Week 104 (Phase A+B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omarigliptin (Phase A) → Omarigliptin (Phase B)', 'description': 'Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks.'}, {'id': 'OG001', 'title': 'Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B)', 'description': 'Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.42', 'groupId': 'OG000', 'lowerLimit': '-0.59', 'upperLimit': '-0.25'}, {'value': '-0.51', 'groupId': 'OG001', 'lowerLimit': '-0.68', 'upperLimit': '-0.34'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 104', 'description': 'A1C is measured as a percent. Change from baseline in A1C at Week 104 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, time, and the interaction of time by treatment.', 'unitOfMeasure': 'Percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set population included all randomized participants who received at least one dose of study medication and had a baseline measurement or a post-randomization measurement.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in FPG at Week 104 (Phase A+B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omarigliptin (Phase A) → Omarigliptin (Phase B)', 'description': 'Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks.'}, {'id': 'OG001', 'title': 'Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B)', 'description': 'Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.8', 'groupId': 'OG000', 'lowerLimit': '-14.4', 'upperLimit': '-1.3'}, {'value': '-18.2', 'groupId': 'OG001', 'lowerLimit': '-24.7', 'upperLimit': '-11.7'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 104', 'description': 'Change from baseline in FPG at Week 104 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, time, and the interaction of time by treatment.', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set population included all randomized participants who received at least one dose of study medication and had a baseline measurement or a post-randomization measurement.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Attaining A1C Glycemic Goals of <7.0% After 24 Weeks of Treatment (Phase A)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omarigliptin (Phase A)', 'description': 'Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo to Omarigliptin (Phase A)', 'description': 'Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '38.0', 'groupId': 'OG000', 'lowerLimit': '31.3', 'upperLimit': '45.1'}, {'value': '18.8', 'groupId': 'OG001', 'lowerLimit': '13.9', 'upperLimit': '25.0'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Between-group rate difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.2', 'ciLowerLimit': '10.1', 'ciUpperLimit': '28.0', 'statisticalMethod': 'Miettinen & Nurminen method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks', 'description': 'Percentage of participants attaining A1C glycemic goals of \\<7.0% (53 mmol/mol) after 24 weeks of treatment estimated using standard multiple imputation techniques.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Attaining A1C Glycemic Goals of <6.5% After 24 Weeks of Treatment (Phase A)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omarigliptin (Phase A)', 'description': 'Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo to Omarigliptin (Phase A)', 'description': 'Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '10.6', 'groupId': 'OG000', 'lowerLimit': '6.8', 'upperLimit': '16.2'}, {'value': '6.4', 'groupId': 'OG001', 'lowerLimit': '3.6', 'upperLimit': '11.2'}]}]}], 'analyses': [{'pValue': '0.164', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Between-group rate difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.2', 'ciLowerLimit': '-1.8', 'ciUpperLimit': '10.5', 'statisticalMethod': 'Miettinen & Nurminen method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks', 'description': 'Percentage of participants attaining A1C glycemic goals of \\<6.5% (48 mmol/mol) after 24 weeks of treatment estimated using standard multiple imputation techniques.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Attaining A1C Glycemic Goals of <7% After 104 Weeks of Treatment (Phase A+B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omarigliptin (Phase A) → Omarigliptin (Phase B)', 'description': 'Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks.'}, {'id': 'OG001', 'title': 'Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B)', 'description': 'Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '32.2', 'groupId': 'OG000', 'lowerLimit': '25.7', 'upperLimit': '39.5'}, {'value': '39.0', 'groupId': 'OG001', 'lowerLimit': '31.7', 'upperLimit': '46.8'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '104 weeks', 'description': 'Percentage of participants attaining A1C glycemic goals of \\<7.0% (53 mmol/mol) after 104 weeks of treatment estimated using standard multiple imputation techniques.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set population included all randomized participants who received at least one dose of study medication and had a baseline measurement or a post-randomization measurement.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Attaining A1C Glycemic Goals of <6.5% After 104 Weeks of Treatment (Phase A+B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omarigliptin (Phase A) → Omarigliptin (Phase B)', 'description': 'Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks.'}, {'id': 'OG001', 'title': 'Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B)', 'description': 'Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.7', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '19.6'}, {'value': '17.9', 'groupId': 'OG001', 'lowerLimit': '12.5', 'upperLimit': '24.8'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '104 weeks', 'description': 'Percentage of participants attaining A1C glycemic goals of \\<6.5% (48 mmol/mol) after 104 weeks of treatment estimated using standard multiple imputation techniques.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set population included all randomized participants who received at least one dose of study medication and had a baseline measurement or a post-randomization measurement.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in PMG Total Area Under the Plasma Concentration Time Curve (AUC) at Week 24 (Phase A)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omarigliptin (Phase A)', 'description': 'Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo to Omarigliptin (Phase A)', 'description': 'Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-46.4', 'groupId': 'OG000', 'lowerLimit': '-58.7', 'upperLimit': '-34.1'}, {'value': '-18.6', 'groupId': 'OG001', 'lowerLimit': '-31.5', 'upperLimit': '-5.7'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-27.8', 'ciLowerLimit': '-44.8', 'ciUpperLimit': '-10.8', 'statisticalMethod': 'cLDA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on a cLDA method with a restriction of the same baseline mean.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'Change from baseline in PMG total AUC at Week 24 based on a cLDA model including terms for treatment, time, and the interaction of time by treatment. Plasma glucose levels were measured before the meal (0 minutes), and at 60 and 120 minutes after the meal.', 'unitOfMeasure': 'mg*h/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Insulin at Week 24 (Phase A)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omarigliptin (Phase A)', 'description': 'Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo to Omarigliptin (Phase A)', 'description': 'Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000', 'lowerLimit': '-0.6', 'upperLimit': '4.2'}, {'value': '-1.9', 'groupId': 'OG001', 'lowerLimit': '-4.3', 'upperLimit': '0.5'}]}]}], 'analyses': [{'pValue': '0.025', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.7', 'ciLowerLimit': '0.5', 'ciUpperLimit': '6.9', 'statisticalMethod': 'cLDA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on a cLDA method with a restriction of the same baseline mean.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'Change from baseline in fasting insulin at Week 24 based on a cLDA model including terms for treatment, time, and the interaction of time by treatment.', 'unitOfMeasure': 'micro International Unit (μIU)/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Insulin at Week 104 (Phase A+B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omarigliptin (Phase A) → Omarigliptin (Phase B)', 'description': 'Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks.'}, {'id': 'OG001', 'title': 'Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B)', 'description': 'Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000', 'lowerLimit': '-1.9', 'upperLimit': '4.2'}, {'value': '1.8', 'groupId': 'OG001', 'lowerLimit': '-1.2', 'upperLimit': '4.8'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 104', 'description': 'Change from baseline in fasting insulin at Week 104 based on a cLDA model including terms for treatment, time, and the interaction of time by treatment.', 'unitOfMeasure': 'μIU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set population included all randomized participants who received at least one dose of study medication and had a baseline measurement or a post-randomization measurement.'}, {'type': 'SECONDARY', 'title': 'Kaplan-Meier Estimate of Cumulative Incidence of Participants Requiring Glycemic Rescue Therapy by 24 Weeks (Phase A)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omarigliptin (Phase A)', 'description': 'Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo to Omarigliptin (Phase A)', 'description': 'Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000', 'lowerLimit': '5.3', 'upperLimit': '13.6'}, {'value': '9.7', 'groupId': 'OG001', 'lowerLimit': '6.2', 'upperLimit': '15.0'}]}]}], 'analyses': [{'pValue': '0.654', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Kaplan-Meier difference %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.2', 'ciLowerLimit': '-7.0', 'ciUpperLimit': '4.7', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 weeks', 'description': 'Participants who did not meet progressively stricter glycemic criteria in Phase A had rescue initiated with open-label glimepiride.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomized population.'}, {'type': 'SECONDARY', 'title': 'Kaplan-Meier Estimate of Cumulative Incidence of Participants Requiring Glycemic Rescue Therapy by 104 Weeks (Phase A+B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omarigliptin (Phase A) → Omarigliptin (Phase B)', 'description': 'Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks.'}, {'id': 'OG001', 'title': 'Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B)', 'description': 'Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.2', 'groupId': 'OG000', 'lowerLimit': '14.9', 'upperLimit': '27.1'}, {'value': '16.2', 'groupId': 'OG001', 'lowerLimit': '11.5', 'upperLimit': '22.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 104 weeks', 'description': 'Participants who did not meet progressively stricter glycemic criteria in Phase A had rescue initiated with open-label glimepiride. If during Phase B participants on open-label glimepiride or blinded glimepiride/glimepiride matching placebo needed rescue after maximum up-titration, then insulin glargine was initiated and the dose of open-label glimepiride or blinded glimepiride/glimepiride-matching placebo was discontinued.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomized population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Requiring Glycemic Rescue Therapy at or Before Week 24 (Phase A)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omarigliptin (Phase A)', 'description': 'Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo to Omarigliptin (Phase A)', 'description': 'Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000', 'lowerLimit': '5.3', 'upperLimit': '13.6'}, {'value': '9.0', 'groupId': 'OG001', 'lowerLimit': '6.2', 'upperLimit': '15.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 weeks', 'description': 'Data presented are a cumulative incidence of participants with glycemic rescue by Week 24.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomized population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Requiring Glycemic Rescue Therapy at or Before Week 104 (Phase A+B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omarigliptin (Phase A) → Omarigliptin (Phase B)', 'description': 'Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks.'}, {'id': 'OG001', 'title': 'Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B)', 'description': 'Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.4', 'groupId': 'OG000'}, {'value': '13.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 104 weeks', 'description': 'Data presented are a cumulative incidence of participants with glycemic rescue by Week 104.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomized population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Omarigliptin (Phase A) → Omarigliptin (Phase B)', 'description': 'Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks.'}, {'id': 'FG001', 'title': 'Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B)', 'description': 'Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks.'}], 'periods': [{'title': 'Phase A (Weeks 0-24)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '201'}, {'groupId': 'FG001', 'numSubjects': '201'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '184'}, {'groupId': 'FG001', 'numSubjects': '177'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '24'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Non-compliance with study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Creatinine or eGFR Discon. Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Need for Excluded Med. Discon. Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Phase B (Weeks 24-104)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '1 participant who completed Phase A did not continue to Phase B.', 'groupId': 'FG000', 'numSubjects': '183'}, {'groupId': 'FG001', 'numSubjects': '177'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '144'}, {'groupId': 'FG001', 'numSubjects': '141'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '36'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '31'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'BG000'}, {'value': '201', 'groupId': 'BG001'}, {'value': '402', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Omarigliptin (Phase A)', 'description': 'Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.'}, {'id': 'BG001', 'title': 'Placebo to Omarigliptin (Phase A)', 'description': 'Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.5', 'spread': '8.1', 'groupId': 'BG000'}, {'value': '56.8', 'spread': '9.1', 'groupId': 'BG001'}, {'value': '57.2', 'spread': '8.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '199', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '203', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hemoglobin A1C (A1C)', 'classes': [{'categories': [{'measurements': [{'value': '8.06', 'spread': '0.87', 'groupId': 'BG000'}, {'value': '8.02', 'spread': '0.89', 'groupId': 'BG001'}, {'value': '8.04', 'spread': '0.88', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percent', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': '2-hour post-meal glucose (2-hr PMG)', 'classes': [{'categories': [{'measurements': [{'value': '240.2', 'spread': '60.5', 'groupId': 'BG000'}, {'value': '236.0', 'spread': '59.9', 'groupId': 'BG001'}, {'value': '238.1', 'spread': '60.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Omarigliptin (Phase A), n=192; Placebo to omarigliptin (Phase A), n=193; Total, n=385', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting plasma glucose (FPG)', 'classes': [{'categories': [{'measurements': [{'value': '168.8', 'spread': '37.6', 'groupId': 'BG000'}, {'value': '168.6', 'spread': '37.2', 'groupId': 'BG001'}, {'value': '168.7', 'spread': '37.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}]}}, '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': 402}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2016-03-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-09', 'studyFirstSubmitDate': '2012-12-18', 'resultsFirstSubmitDate': '2017-01-30', 'studyFirstSubmitQcDate': '2012-12-18', 'lastUpdatePostDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-01-30', 'studyFirstPostDateStruct': {'date': '2012-12-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Glycosylated Hemoglobin (A1C) at Week 24 (Phase A)', 'timeFrame': 'Baseline and Week 24', 'description': 'A1C is measured as a percent. Change from baseline in A1C at Week 24 was analyzed using a constrained longitudinal data analysis (cLDA) method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, time, and the interaction of time by treatment.'}, {'measure': 'Percentage of Participants Who Experienced at Least One Adverse Event (Phase A+B)', 'timeFrame': 'Up to 107 weeks', 'description': 'An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.'}, {'measure': 'Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (Phase A+B)', 'timeFrame': 'Up to 104 weeks', 'description': 'An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.'}, {'measure': 'Percentage of Participants Who Experienced an Adverse Event Which Were Included Under the System Order Class of Investigations (Phase A+B)', 'timeFrame': 'Up to 104 weeks', 'description': 'The following laboratory parameters were included: blood chemistry, hematology, electrocardiograms, lipids, body weight, and vital signs.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24 (Phase A)', 'timeFrame': 'Baseline and Week 24', 'description': 'Change from baseline in 2-hour PMG at Week 24 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, time, and the interaction of time by treatment.'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Phase A)', 'timeFrame': 'Baseline and Week 24', 'description': 'Change from baseline in FPG at Week 24 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, time, and the interaction of time by treatment.'}, {'measure': 'Change From Baseline in A1C at Week 104 (Phase A+B)', 'timeFrame': 'Baseline and Week 104', 'description': 'A1C is measured as a percent. Change from baseline in A1C at Week 104 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, time, and the interaction of time by treatment.'}, {'measure': 'Change From Baseline in FPG at Week 104 (Phase A+B)', 'timeFrame': 'Baseline and Week 104', 'description': 'Change from baseline in FPG at Week 104 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, time, and the interaction of time by treatment.'}, {'measure': 'Percentage of Participants Attaining A1C Glycemic Goals of <7.0% After 24 Weeks of Treatment (Phase A)', 'timeFrame': '24 weeks', 'description': 'Percentage of participants attaining A1C glycemic goals of \\<7.0% (53 mmol/mol) after 24 weeks of treatment estimated using standard multiple imputation techniques.'}, {'measure': 'Percentage of Participants Attaining A1C Glycemic Goals of <6.5% After 24 Weeks of Treatment (Phase A)', 'timeFrame': '24 weeks', 'description': 'Percentage of participants attaining A1C glycemic goals of \\<6.5% (48 mmol/mol) after 24 weeks of treatment estimated using standard multiple imputation techniques.'}, {'measure': 'Percentage of Participants Attaining A1C Glycemic Goals of <7% After 104 Weeks of Treatment (Phase A+B)', 'timeFrame': '104 weeks', 'description': 'Percentage of participants attaining A1C glycemic goals of \\<7.0% (53 mmol/mol) after 104 weeks of treatment estimated using standard multiple imputation techniques.'}, {'measure': 'Percentage of Participants Attaining A1C Glycemic Goals of <6.5% After 104 Weeks of Treatment (Phase A+B)', 'timeFrame': '104 weeks', 'description': 'Percentage of participants attaining A1C glycemic goals of \\<6.5% (48 mmol/mol) after 104 weeks of treatment estimated using standard multiple imputation techniques.'}, {'measure': 'Change From Baseline in PMG Total Area Under the Plasma Concentration Time Curve (AUC) at Week 24 (Phase A)', 'timeFrame': 'Baseline and Week 24', 'description': 'Change from baseline in PMG total AUC at Week 24 based on a cLDA model including terms for treatment, time, and the interaction of time by treatment. Plasma glucose levels were measured before the meal (0 minutes), and at 60 and 120 minutes after the meal.'}, {'measure': 'Change From Baseline in Fasting Insulin at Week 24 (Phase A)', 'timeFrame': 'Baseline and Week 24', 'description': 'Change from baseline in fasting insulin at Week 24 based on a cLDA model including terms for treatment, time, and the interaction of time by treatment.'}, {'measure': 'Change From Baseline in Fasting Insulin at Week 104 (Phase A+B)', 'timeFrame': 'Baseline and Week 104', 'description': 'Change from baseline in fasting insulin at Week 104 based on a cLDA model including terms for treatment, time, and the interaction of time by treatment.'}, {'measure': 'Kaplan-Meier Estimate of Cumulative Incidence of Participants Requiring Glycemic Rescue Therapy by 24 Weeks (Phase A)', 'timeFrame': 'Up to 24 weeks', 'description': 'Participants who did not meet progressively stricter glycemic criteria in Phase A had rescue initiated with open-label glimepiride.'}, {'measure': 'Kaplan-Meier Estimate of Cumulative Incidence of Participants Requiring Glycemic Rescue Therapy by 104 Weeks (Phase A+B)', 'timeFrame': 'Up to 104 weeks', 'description': 'Participants who did not meet progressively stricter glycemic criteria in Phase A had rescue initiated with open-label glimepiride. If during Phase B participants on open-label glimepiride or blinded glimepiride/glimepiride matching placebo needed rescue after maximum up-titration, then insulin glargine was initiated and the dose of open-label glimepiride or blinded glimepiride/glimepiride-matching placebo was discontinued.'}, {'measure': 'Percentage of Participants Requiring Glycemic Rescue Therapy at or Before Week 24 (Phase A)', 'timeFrame': 'Up to 24 weeks', 'description': 'Data presented are a cumulative incidence of participants with glycemic rescue by Week 24.'}, {'measure': 'Percentage of Participants Requiring Glycemic Rescue Therapy at or Before Week 104 (Phase A+B)', 'timeFrame': 'Up to 104 weeks', 'description': 'Data presented are a cumulative incidence of participants with glycemic rescue by Week 104.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '28547998', 'type': 'RESULT', 'citation': 'Shankar RR, Inzucchi SE, Scarabello V, Gantz I, Kaufman KD, Lai E, Ceesay P, Suryawanshi S, Engel SS. A randomized clinical trial evaluating the efficacy and safety of the once-weekly dipeptidyl peptidase-4 inhibitor omarigliptin in patients with type 2 diabetes inadequately controlled on metformin monotherapy. Curr Med Res Opin. 2017 Oct;33(10):1853-1860. doi: 10.1080/03007995.2017.1335637. Epub 2017 Jun 23.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety and efficacy of omarigliptin compared to placebo in participants with inadequate glycemic control on metformin monotherapy. The primary hypothesis is that after 24 weeks, the addition of treatment with omarigliptin provides greater reduction in hemoglobin A1c (A1C) than placebo.', 'detailedDescription': 'Participants received blinded omarigliptin or matching placebo to omarigliptin for 104 weeks. During the first 24 weeks (Phase A) they did not receive any other blinded study medication. In Phase B (subsequent 80 weeks), participants who did not initiate glycemic rescue in Phase A received additional blinded study medication: participants in the omarigliptin group received placebo to glimepiride and participants in the placebo group received glimepiride.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has type 2 diabetes mellitus\n* Currently on a stable dose of metformin monotherapy (\\>=1500 mg per day) for at least 12 weeks prior to study participation\n* Male, or female who is not of reproductive potential or if of reproductive potential agrees to abstain from heterosexual activity or use (or have their partner use) acceptable contraception to prevent pregnancy during the study and for 21 days after the last dose of study drug\n\nExclusion Criteria:\n\n* History of type 1 diabetes mellitus or a history of ketoacidosis\n* Has been treated with any antihyperglycemic agent (AHA) other than the protocol-required metformin within 12 weeks prior to study participation or with omarigliptin at any time prior to signing informed consent\n* History of hypersensitivity to a dipeptidyl peptidase IV (DPP-4) inhibitor\n* History of intolerance, hypersensitivity, or any other contraindication to metformin, glimepiride, or insulin glargine\n* Is on a weight loss program and is not in the maintenance phase or has been on a weight loss medication in the past 6 months or has undergone bariatric surgery within 12 months prior to study participation\n* Has undergone a surgical procedure within 4 weeks of study participation or has planned major surgery during the study\n* Is on or likely to require treatment for \\>=2 consecutive weeks or repeated courses of corticosteroids (inhaled, nasal and topical corticosteroids are permitted)\n* Currently being treated for hyperthyroidism or is on thyroid hormone replacement therapy and has not been on a stable dose for at least 6 weeks\n* Is expecting to undergo hormonal therapy in preparation to donate eggs during the period of the trial, including 21 days after the last dose of blinded study medication\n* History of active liver disease (other than non-alcoholic steatosis) including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease\n* Human immunodeficiency virus (HIV)\n* New or worsening signs or symptoms of coronary heart disease or congestive heart failure within the past 3 months, or myocardial infarction, unstable angina, coronary artery bypass grafting, percutaneous transluminal coronary angioplasty, stroke, or transient ischemic attacks in the past 3 months\n* Poorly controlled hypertension\n* History of malignancy \\<=5 years prior to study participation, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer\n* Hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia)\n* Positive urine pregnancy test\n* Pregnant or breastfeeding, or is expecting to conceive during the study including 21 days following the last dose of blinded study drug\n* User of recreational or illicit drugs or has had a recent history of drug abuse\n* Routinely consumes \\>2 alcoholic drinks per day or \\>14 alcoholic drinks per week, or engages in binge drinking\n* Has donated blood products or has had phlebotomy of \\>300 mL within 8 weeks of study participation, or intends to donate blood products within the projected duration of the trial or has received, or is anticipated to receive, blood products within 12 weeks of study participation or within the projected duration of the trial'}, 'identificationModule': {'nctId': 'NCT01755156', 'briefTitle': 'A Study to Evaluate the Safety, Tolerability, and Efficacy of the Addition of Omarigliptin (MK-3102) to Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Therapy (MK-3102-024)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Efficacy of the Addition of MK-3102 to Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Therapy', 'orgStudyIdInfo': {'id': '3102-024'}, 'secondaryIdInfos': [{'id': '2012-003670-11', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Omarigliptin (Phase A) → Omarigliptin (Phase B)', 'description': 'Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks. Participants will continue pre-study metformin throughout the duration of the study. If necessary, rescue therapy may be initiated (open-label glimepiride during Phase A and insulin glargine during Phase B).', 'interventionNames': ['Drug: Omarigliptin', 'Drug: Matching placebo to glimepiride', 'Drug: Insulin glargine', 'Drug: Metformin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo to omarigliptin (Phase A) → Glimepiride (Phase B)', 'description': 'Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks. Participants will continue pre-study metformin throughout the duration of the study. If necessary, rescue therapy may be initiated (open-label glimepiride during Phase A and insulin glargine during Phase B).', 'interventionNames': ['Drug: Matching placebo to omarigliptin', 'Drug: Glimepiride', 'Drug: Insulin glargine', 'Drug: Metformin']}], 'interventions': [{'name': 'Omarigliptin', 'type': 'DRUG', 'otherNames': ['MK-3102'], 'description': 'Omarigliptin 25 mg capsule administered orally once weekly (preferably on the same day of each week)', 'armGroupLabels': ['Omarigliptin (Phase A) → Omarigliptin (Phase B)']}, {'name': 'Matching placebo to omarigliptin', 'type': 'DRUG', 'description': 'Matching placebo to omarigliptin capsule administered orally once weekly (preferably on the same day of each week)', 'armGroupLabels': ['Placebo to omarigliptin (Phase A) → Glimepiride (Phase B)']}, {'name': 'Glimepiride', 'type': 'DRUG', 'otherNames': ['Amaryl®'], 'description': 'Glimepiride 1 or 2 mg tablet/capsule administered orally once daily and up-titrated to a maximum dose of 6 mg daily. Participants rescued with open-label glimepiride during Phase A will not receive glimepiride or matching placebo to glimepiride during Phase B.', 'armGroupLabels': ['Placebo to omarigliptin (Phase A) → Glimepiride (Phase B)']}, {'name': 'Matching placebo to glimepiride', 'type': 'DRUG', 'description': 'Matching placebo to glimepiride tablet/capsule administered orally once daily and up-titrated to a mock maximum dose of 6 mg daily. Participants rescued with open-label glimepiride during Phase A will not receive glimepiride or matching placebo to glimepiride during Phase B.', 'armGroupLabels': ['Omarigliptin (Phase A) → Omarigliptin (Phase B)']}, {'name': 'Insulin glargine', 'type': 'DRUG', 'otherNames': ['Lantus'], 'description': 'During Phase B of the study, participants who received a maximum up-titration of open-label glimepiride or blinded glimepiride/matching placebo to glimepiride, may be rescued with open-label insulin glargine.', 'armGroupLabels': ['Omarigliptin (Phase A) → Omarigliptin (Phase B)', 'Placebo to omarigliptin (Phase A) → Glimepiride (Phase B)']}, {'name': 'Metformin', 'type': 'DRUG', 'otherNames': ['Fortamet®', 'Glucophage®', 'Glucophage® XR', 'Glumetza®', 'Riomet®', 'Metgluco®', 'Glycoran®'], 'description': 'Participants continue stable pre-study dose of metformin tablet(s) administered orally (\\>= 1500 mg daily) throughout the study.', 'armGroupLabels': ['Omarigliptin (Phase A) → Omarigliptin (Phase B)', 'Placebo to omarigliptin (Phase A) → Glimepiride (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'}}}}