Viewing Study NCT01682759

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
Ignite Creation Date: 2025-12-24 @ 2:46 PM
Ignite Modification Date: 2026-01-04 @ 1:20 PM
Study NCT ID: NCT01682759
Status: COMPLETED
Last Update Posted: 2018-09-07
First Post: 2012-09-07
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: A Study of the Safety and Efficacy of Omarigliptin (MK-3102) Compared With Glimepiride in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-3102-016)
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Croatia', 'Germany', 'Hungary', 'Lebanon', 'Lithuania', 'Malaysia', 'Poland', 'Romania', 'South Korea', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'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': 'D008687', 'term': 'Metformin'}, {'id': 'D000069036', 'term': 'Insulin Glargine'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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'}]}}, '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 Week 57', 'description': 'Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.', 'eventGroups': [{'id': 'EG000', 'title': 'Omarigliptin', 'description': 'Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.', 'otherNumAtRisk': 375, 'otherNumAffected': 43, 'seriousNumAtRisk': 375, 'seriousNumAffected': 24}, {'id': 'EG001', 'title': 'Glimepiride', 'description': 'Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.', 'otherNumAtRisk': 375, 'otherNumAffected': 125, 'seriousNumAtRisk': 375, 'seriousNumAffected': 18}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numEvents': 31, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 375, 'numEvents': 30, 'numAffected': 23}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numEvents': 45, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 375, 'numEvents': 487, 'numAffected': 110}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'seriousEvents': [{'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 375, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 375, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 375, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 375, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 375, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 375, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 375, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 375, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Diverticulum intestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 375, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 375, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Large intestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 375, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Large intestine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 375, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Rectal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 375, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Impaired healing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 375, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 375, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 375, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 375, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Carbuncle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 375, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 375, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cholecystitis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 375, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 375, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 375, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pulmonary sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 375, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Septic arthritis staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 375, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Dumping syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 375, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 375, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Traumatic haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 375, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 375, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 375, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 375, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 375, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 375, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 375, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Angiomyolipoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 375, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 375, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Intraductal proliferative breast lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 375, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Lipoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 375, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Lung neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 375, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 375, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 375, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 375, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 375, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Lumbar radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 375, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Metabolic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 375, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 375, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Trigeminal neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 375, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 375, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Diabetic foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 375, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 375, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Hemoglobin A1C at Week 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '375', 'groupId': 'OG000'}, {'value': '375', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omarigliptin', 'description': 'Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.'}, {'id': 'OG001', 'title': 'Glimepiride', 'description': 'Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.30', 'groupId': 'OG000', 'lowerLimit': '-0.39', 'upperLimit': '-0.21'}, {'value': '-0.48', 'groupId': 'OG001', 'lowerLimit': '-0.57', 'upperLimit': '-0.39'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in the least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.18', 'ciLowerLimit': '0.06', 'ciUpperLimit': '0.30', 'estimateComment': 'Constrained longitudinal data analysis (cLDA) model including terms for treatment, time, and the interaction of time by treatment, with the constraint that the mean baseline is the same for all treatment groups.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Omarigliptin was considered non-inferior to glimepiride if the upper bound of the two-sided 95% confidence interval (CI) of the between-treatment difference in least-squares (LS) means for change from baseline in A1C at Week 54 (omarigliptin vs. glimepiride) was lower than 0.35%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 54', 'description': 'Hemoglobin A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 54 A1C minus the Week 0 A1C.', 'unitOfMeasure': 'A1C (%)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) population consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '375', 'groupId': 'OG000'}, {'value': '375', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omarigliptin', 'description': 'Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.'}, {'id': 'OG001', 'title': 'Glimepiride', 'description': 'Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '54.7', 'groupId': 'OG000'}, {'value': '61.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.9', 'ciLowerLimit': '-13.9', 'ciUpperLimit': '0.1', 'estimateComment': 'Miettinen \\& Nurminen method; the 95% CI was computed only for those endpoints with at least 4 participants having events in one or more treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 57', '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.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Subjects as Treated (ASaT) population, defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Discontinued From the Study Due to an Adverse Event Excluding Data After Glycemic Rescue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '375', 'groupId': 'OG000'}, {'value': '375', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omarigliptin', 'description': 'Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.'}, {'id': 'OG001', 'title': 'Glimepiride', 'description': 'Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000'}, {'value': '2.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '3.8', 'estimateComment': 'Miettinen \\& Nurminen method; the 95% CI was computed only for those endpoints with at least 4 participants having events in one or more treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 54', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ASaT Population is defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose at Week 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '375', 'groupId': 'OG000'}, {'value': '375', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omarigliptin', 'description': 'Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.'}, {'id': 'OG001', 'title': 'Glimepiride', 'description': 'Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.7', 'groupId': 'OG000', 'lowerLimit': '-6.7', 'upperLimit': '1.3'}, {'value': '-8.3', 'groupId': 'OG001', 'lowerLimit': '-12.4', 'upperLimit': '-4.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in the least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.6', 'ciLowerLimit': '0.1', 'ciUpperLimit': '11.2', 'estimateComment': 'cLDA model including terms for treatment, time, and the interaction of time by treatment, with the constraint that the mean baseline is the same for all treatment groups', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 54', 'description': 'Blood glucose was measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 54 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 54 minus FPG at baseline).', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS population consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving a Hemoglobin A1C of <6.5% at Week 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '375', 'groupId': 'OG000'}, {'value': '375', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omarigliptin', 'description': 'Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.'}, {'id': 'OG001', 'title': 'Glimepiride', 'description': 'Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.1', 'groupId': 'OG000', 'lowerLimit': '20.6', 'upperLimit': '30.2'}, {'value': '28.8', 'groupId': 'OG001', 'lowerLimit': '24.1', 'upperLimit': '34.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Between-group Rate Difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.7', 'ciLowerLimit': '-10.6', 'ciUpperLimit': '3.3', 'estimateComment': 'Between-group CIs are calculated via Miettinen \\& Nurminen method.', 'groupDescription': 'A1C \\<6.5%', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 54', 'description': 'The percentage of participants who achieved A1C values \\<6.5% (48 mmol/mol) in the FAS Population at Week 54.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS Population (with multiple imputation) consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With an Adverse Event of Symptomatic Hypoglycemia Excluding Data After Glycemic Rescue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '375', 'groupId': 'OG000'}, {'value': '375', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omarigliptin', 'description': 'Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.'}, {'id': 'OG001', 'title': 'Glimepiride', 'description': 'Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000'}, {'value': '26.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-21.3', 'ciLowerLimit': '-26.5', 'ciUpperLimit': '-16.4', 'estimateComment': 'Miettinen \\& Nurminen method; the 95% CI was computed only for those endpoints with at least 4 participants having events in one or more treatment groups.', 'statisticalMethod': 'Difference in percentages', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 54', 'description': 'Symptomatic episode of hypoglycemia was an episode with clinical symptoms reported by the investigator as hypoglycemia (concurrent fingerstick glucose not required).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ASaT Population is defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Weight at Week 54 Excluding Data After Gylcemic Rescue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '375', 'groupId': 'OG000'}, {'value': '375', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omarigliptin', 'description': 'Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.'}, {'id': 'OG001', 'title': 'Glimepiride', 'description': 'Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.4', 'groupId': 'OG000', 'lowerLimit': '-0.8', 'upperLimit': '-0.0'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '1.9'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in the least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.9', 'ciLowerLimit': '-2.5', 'ciUpperLimit': '-1.4', 'estimateComment': 'cLDA model including terms for treatment, time, and the interaction of time by treatment with the constraint that the mean baseline is the same for all treatment groups.', 'statisticalMethod': 'Difference in the least squares means', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 54', 'unitOfMeasure': 'kg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ASaT Population is defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving a Hemoglobin A1C of <7.0% at Week 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '375', 'groupId': 'OG000'}, {'value': '375', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omarigliptin', 'description': 'Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.'}, {'id': 'OG001', 'title': 'Glimepiride', 'description': 'Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '47.7', 'groupId': 'OG000', 'lowerLimit': '42.3', 'upperLimit': '53.1'}, {'value': '58.0', 'groupId': 'OG001', 'lowerLimit': '52.7', 'upperLimit': '63.1'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Between-group Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.3', 'ciLowerLimit': '-17.8', 'ciUpperLimit': '-2.8', 'estimateComment': 'Between-group CIs are calculated via Miettinen \\& Nurminen method.', 'groupDescription': 'A1C \\< 7.0%', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 54', 'description': 'The percentage of participants who achieved A1C values \\<7.0% (53 mmol/mol) in the FAS Population at Week 54.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS Population (with multiple imputation) consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Omarigliptin', 'description': 'Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.'}, {'id': 'FG001', 'title': 'Glimepiride', 'description': 'Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '376'}, {'groupId': 'FG001', 'numSubjects': '375'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '375'}, {'groupId': 'FG001', 'numSubjects': '375'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '307'}, {'groupId': 'FG001', 'numSubjects': '305'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '70'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '55'}]}]}], 'recruitmentDetails': 'In total, 1197 participants at 115 clinical sites were screened and 446 participants were excluded during screening. The most common reason for participants not being randomized was screen failure. The most common reasons for screen failure were participants not meeting the metformin inclusion criteria or meeting exclusionary laboratory values.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'BG000'}, {'value': '375', 'groupId': 'BG001'}, {'value': '751', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Omarigliptin', 'description': 'Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.'}, {'id': 'BG001', 'title': 'Glimepiride', 'description': 'Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.9', 'spread': '9.6', 'groupId': 'BG000'}, {'value': '57.6', 'spread': '9.3', 'groupId': 'BG001'}, {'value': '57.7', 'spread': '9.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '173', 'groupId': 'BG000'}, {'value': '164', 'groupId': 'BG001'}, {'value': '337', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '203', 'groupId': 'BG000'}, {'value': '211', 'groupId': 'BG001'}, {'value': '414', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hemoglobin A1C', 'classes': [{'categories': [{'measurements': [{'value': '7.49', 'spread': '0.75', 'groupId': 'BG000'}, {'value': '7.43', 'spread': '0.72', 'groupId': 'BG001'}, {'value': '7.46', 'spread': '0.73', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'For both the Omarigliptin and Glimepiride groups n=375', 'unitOfMeasure': 'A1C (%)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting Plamsa Glucose (FPG)', 'classes': [{'categories': [{'measurements': [{'value': '155.3', 'spread': '31.4', 'groupId': 'BG000'}, {'value': '152.7', 'spread': '30.0', 'groupId': 'BG001'}, {'value': '154.0', 'spread': '30.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'For both the Omarigliptin and Glimepiride groups n=375', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Weight', 'classes': [{'categories': [{'measurements': [{'value': '87.5', 'spread': '18.1', 'groupId': 'BG000'}, {'value': '88.7', 'spread': '18.7', 'groupId': 'BG001'}, {'value': '88.1', 'spread': '18.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'For both the Omarigliptin and Glimepiride groups n=375', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 751}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2015-01-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-08', 'studyFirstSubmitDate': '2012-09-07', 'resultsFirstSubmitDate': '2016-01-06', 'studyFirstSubmitQcDate': '2012-09-07', 'lastUpdatePostDateStruct': {'date': '2018-09-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-01-06', 'studyFirstPostDateStruct': {'date': '2012-09-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-02-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Hemoglobin A1C at Week 54', 'timeFrame': 'Baseline and Week 54', 'description': 'Hemoglobin A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 54 A1C minus the Week 0 A1C.'}, {'measure': 'Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue', 'timeFrame': 'Up to Week 57', '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.'}, {'measure': 'Percentage of Participants Who Discontinued From the Study Due to an Adverse Event Excluding Data After Glycemic Rescue', 'timeFrame': 'Up to Week 54'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Fasting Plasma Glucose at Week 54', 'timeFrame': 'Baseline and Week 54', 'description': 'Blood glucose was measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 54 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 54 minus FPG at baseline).'}, {'measure': 'Percentage of Participants Achieving a Hemoglobin A1C of <6.5% at Week 54', 'timeFrame': 'Week 54', 'description': 'The percentage of participants who achieved A1C values \\<6.5% (48 mmol/mol) in the FAS Population at Week 54.'}, {'measure': 'Percentage of Participants With an Adverse Event of Symptomatic Hypoglycemia Excluding Data After Glycemic Rescue', 'timeFrame': 'Up to Week 54', 'description': 'Symptomatic episode of hypoglycemia was an episode with clinical symptoms reported by the investigator as hypoglycemia (concurrent fingerstick glucose not required).'}, {'measure': 'Change From Baseline in Body Weight at Week 54 Excluding Data After Gylcemic Rescue', 'timeFrame': 'Baseline and Week 54'}, {'measure': 'Percentage of Participants Achieving a Hemoglobin A1C of <7.0% at Week 54', 'timeFrame': 'Week 54', 'description': 'The percentage of participants who achieved A1C values \\<7.0% (53 mmol/mol) in the FAS Population at Week 54.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['diabetes'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '28548024', 'type': 'RESULT', 'citation': "Handelsman Y, Lauring B, Gantz I, Iredale C, O'Neill EA, Wei Z, Suryawanshi S, Kaufman KD, Engel SS, Lai E. A randomized, double-blind, non-inferiority trial evaluating the efficacy and safety of omarigliptin, a once-weekly DPP-4 inhibitor, or glimepiride in patients with type 2 diabetes inadequately controlled on metformin monotherapy. Curr Med Res Opin. 2017 Oct;33(10):1861-1868. doi: 10.1080/03007995.2017.1335638. Epub 2017 Jun 28."}]}, 'descriptionModule': {'briefSummary': 'This trial will assess the safety and efficacy of omarigliptin (MK-3102) compared with the sulfonylurea, glimepiride, in Type 2 diabetes mellitus participants with inadequate glycemic control on metformin monotherapy. The primay hypothesis of the study is that after 54 weeks, the mean change from baseline in hemoglobin A1C (A1C) in participants treated with omarigliptin is non-inferior compared with that in participants treated with glimepiride.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with Type 2 diabetes mellitus\n* On a stable dose of metformin (≥1500 mg/day) for at least 12 weeks with inadequate glycemic control\n* Females of reproductive potential agree to remain abstinent or use or have their partner use acceptable methods of birth control\n\nExclusion Criteria:\n\n* History of type 1 diabetes mellitus or a history of ketoacidosis\n* Treated with any antihyperglycemic agents (AHA) therapies other than the protocol-required metformin within the prior 12 weeks of study participation or with omarigliptin at any time prior to signing informed consent\n* On a weight loss program and is not in the maintenance phase or has\n\nstarted a weight loss medication in the past 6 months or has undergone bariatric surgery within 12 months prior to study participation\n\n* Medical history of active liver disease (other than non-alcoholic\n\nhepatic steatosis), including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease\n\n* Human immunodeficiency virus\n* New or worsening coronary heart disease, congestive heart failure, myocardial infarction, unstable angina, coronary artery intervention, stroke or transient ischemic neurological disorder within the past 3 months\n* History of malignancy ≤5 years prior to study participation except for adequately treated basal cell or squamous cell skin cancer, or in situ\n\ncervical cancer\n\n* Clinically important hematological disorder (such as aplastic anemia,\n\nmyeloproliferative or myelodysplastic syndromes, thrombocytopenia)\n\n* Pregnant or breast-feeding, or is expecting to conceive or donate eggs\n\nduring the trial, including 21 days following the last dose of study drug'}, 'identificationModule': {'nctId': 'NCT01682759', 'briefTitle': 'A Study of the Safety and Efficacy of Omarigliptin (MK-3102) Compared With Glimepiride in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-3102-016)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase III, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of MK-3102 Compared With the Addition of Glimepiride in Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin', 'orgStudyIdInfo': {'id': '3102-016'}, 'secondaryIdInfos': [{'id': 'MK-3102-016', 'type': 'OTHER', 'domain': 'protocol number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Omarigliptin', 'description': 'Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.', 'interventionNames': ['Drug: Omarigliptin', 'Drug: Glimepiride Placebo', 'Drug: Metformin', 'Drug: Insulin Glargine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Glimepiride', 'description': 'Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.', 'interventionNames': ['Drug: Placebo to Omarigliptin', 'Drug: Glimepiride', 'Drug: Metformin', 'Drug: Insulin Glargine']}], 'interventions': [{'name': 'Omarigliptin', 'type': 'DRUG', 'armGroupLabels': ['Omarigliptin']}, {'name': 'Placebo to Omarigliptin', 'type': 'DRUG', 'armGroupLabels': ['Glimepiride']}, {'name': 'Glimepiride', 'type': 'DRUG', 'otherNames': ['AMARYL®', 'GLIMY'], 'description': "Glimepiride (1 mg and/or 2 mg tablets). During the 54-week double-blind treatment period, glimepiride can be up-titrated, as appropriate, to a maximum total daily dose of 6 mg/day. Throughout the trial, down-titration of glimepiride may also occur based upon the participant's glucose measurements and clinical symptoms of hypoglycemia.", 'armGroupLabels': ['Glimepiride']}, {'name': 'Glimepiride Placebo', 'type': 'DRUG', 'armGroupLabels': ['Omarigliptin']}, {'name': 'Metformin', 'type': 'DRUG', 'description': 'Participants will continue on their stable dose (\\>=1500 mg/day) of open-label metformin throughout the trial.', 'armGroupLabels': ['Glimepiride', 'Omarigliptin']}, {'name': 'Insulin Glargine', 'type': 'DRUG', 'description': 'Insulin glargine can be used for rescue therapy, if glycemic control is not maintained. Insulin therapy should be initiated as per local country insulin glargine label.', 'armGroupLabels': ['Glimepiride', 'Omarigliptin']}]}, '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'}}}}