Ignite Creation Date:
2025-12-24 @ 11:50 AM
Ignite Modification Date:
2025-12-24 @ 11:50 AM
Study NCT ID:
NCT01704261
Status:
COMPLETED
Last Update Posted:
2018-09-10
First Post:
2012-10-08
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Addition of Omarigliptin (MK-3102) to Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Combination Therapy With Glimepiride and Metformin (MK-3102-022)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Poland', 'Romania', 'Russia', 'South Africa', 'South Korea', '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': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'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 trial 45 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to Week 27', 'description': 'The ASaT Population was all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant was in 2 clinical trials and was excluded from all efficacy and safety analysis.', 'eventGroups': [{'id': 'EG000', 'title': 'Omarigliptin', 'description': 'Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose \\>=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose \\>=1500 mg per day).', 'otherNumAtRisk': 153, 'otherNumAffected': 29, 'seriousNumAtRisk': 153, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose \\>=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose \\>=1500 mg per day).', 'otherNumAtRisk': 153, 'otherNumAffected': 23, 'seriousNumAtRisk': 153, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 65, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 44, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'seriousEvents': [{'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Duodenal ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cerebrovascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Hemoglobin A1c (A1C) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omarigliptin', 'description': 'Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose \\>=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose \\>=1500 mg per day).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose \\>=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose \\>=1500 mg per day).'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.67', 'groupId': 'OG000', 'lowerLimit': '-0.84', 'upperLimit': '-0.50'}, {'value': '-0.06', 'groupId': 'OG001', 'lowerLimit': '-0.23', 'upperLimit': '0.12'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.61', 'ciLowerLimit': '-0.85', 'ciUpperLimit': '-0.38', 'statisticalMethod': 'Difference in the least squares means', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on a constrained longitudinal data analysis (cLDA) method with a restriction of the same baseline mean across treatment groups.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'A1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 24 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. One participant was in 2 clinical trials in parallel and was excluded from all efficacy and safety analysis.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Experienced at Least One Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omarigliptin', 'description': 'Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose \\>=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose \\>=1500 mg per day).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose \\>=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose \\>=1500 mg per day).'}], 'classes': [{'categories': [{'measurements': [{'value': '57.5', 'groupId': 'OG000'}, {'value': '47.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in % Omarigliptin vs Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.8', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '20.8', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 27', '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. One participant was in 2 clinical trials and was excluded from all efficacy and safety analysis.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Discontinued From the Study Due to an AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omarigliptin', 'description': 'Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose \\>=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose \\>=1500 mg per day).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose \\>=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose \\>=1500 mg per day).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000'}, {'value': '2.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in % Omarigliptin vs Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-4.3', 'ciUpperLimit': '4.3', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 24', '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': 'The ASaT Population was 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. One participant was in 2 clinical trials and was excluded from all efficacy and safety analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omarigliptin', 'description': 'Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose \\>=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose \\>=1500 mg per day).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose \\>=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose \\>=1500 mg per day).'}], 'classes': [{'categories': [{'measurements': [{'value': '-19.6', 'groupId': 'OG000', 'lowerLimit': '-26.7', 'upperLimit': '-12.5'}, {'value': '-3.0', 'groupId': 'OG001', 'lowerLimit': '-10.2', 'upperLimit': '4.1'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of the least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.6', 'ciLowerLimit': '-25.5', 'ciUpperLimit': '-7.8', 'statisticalMethod': 'Difference in the least squares means', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on a constrained longitudinal data analysis (cLDA) method with a restriction of the same baseline mean across treatment groups.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', '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 24 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 24 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. One participant was in 2 clinical trials in parallel and was excluded from all efficacy and safety analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Attaining A1C Glycemic Goals of <7% and <6.5% at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omarigliptin', 'description': 'Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose \\>=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose \\>=1500 mg per day).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose \\>=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose \\>=1500 mg per day).'}], 'classes': [{'title': '<7.0%', 'categories': [{'measurements': [{'value': '23.8', 'groupId': 'OG000', 'lowerLimit': '17.5', 'upperLimit': '31.5'}, {'value': '4.4', 'groupId': 'OG001', 'lowerLimit': '2.1', 'upperLimit': '9.3'}]}]}, {'title': '<6.5%', 'categories': [{'measurements': [{'value': '10.1', 'groupId': 'OG000', 'lowerLimit': '6.1', 'upperLimit': '16.4'}, {'value': '2.1', 'groupId': 'OG001', 'lowerLimit': '0.7', 'upperLimit': '6.0'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Between-group Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.3', 'ciLowerLimit': '11.7', 'ciUpperLimit': '27.6', 'statisticalMethod': 'Miettinen & Nurminen method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Between-group confidence intervals and p-value (%) A1C \\<7.0%; estimated using standard multiple imputation techniques.'}, {'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Between-group Rate Difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.0', 'ciLowerLimit': '2.7', 'ciUpperLimit': '14.5', 'statisticalMethod': 'Miettinen & Nurminen method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Between-group confidence intervals and p-value (%) A1C \\<7.0%; estimated using standard multiple imputation techniques.'}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks', 'description': 'The percentage of participants who achieved A1C values \\<6.5% (48 mmol/mol) or \\<7.0% (53 mmol/mol) in the FAS population at Week 24.', 'unitOfMeasure': 'Percentage of participants', '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. One participant was in 2 clinical trials in parallel and was excluded from all efficacy and safety analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Omarigliptin', 'description': 'Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose \\>=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose \\>=1500 mg per day).'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose \\>=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose \\>=1500 mg per day).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '154'}, {'groupId': 'FG001', 'numSubjects': '153'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '141'}, {'groupId': 'FG001', 'numSubjects': '138'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Fifty-one sites received IEC/IRB approval and were shipped clinical supplies.', 'preAssignmentDetails': 'In total, 583 participants were screened and 276 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 not meeting the metformin and glimepiride dose requirements inclusion criterion or meeting exclusionary laboratory values.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'BG000'}, {'value': '153', 'groupId': 'BG001'}, {'value': '307', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Omarigliptin', 'description': 'Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose \\>=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose \\>=1500 mg per day).'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose \\>=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose \\>=1500 mg per day).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.2', 'spread': '8.4', 'groupId': 'BG000'}, {'value': '58.4', 'spread': '9.4', 'groupId': 'BG001'}, {'value': '57.8', 'spread': '8.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '147', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 307}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2014-12-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-09', 'studyFirstSubmitDate': '2012-10-08', 'resultsFirstSubmitDate': '2015-10-23', 'studyFirstSubmitQcDate': '2012-10-08', 'lastUpdatePostDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-10-23', 'studyFirstPostDateStruct': {'date': '2012-10-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Hemoglobin A1c (A1C) at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'A1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 24 A1C minus the Week 0 A1C.'}, {'measure': 'Percentage of Participants Who Experienced at Least One Adverse Event (AE)', 'timeFrame': 'Up to Week 27', '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 AE', 'timeFrame': 'Up to Week 24', '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.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24', 'timeFrame': 'Baseline and Week 24', '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 24 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 24 minus FPG at baseline).'}, {'measure': 'Percentage of Participants Attaining A1C Glycemic Goals of <7% and <6.5% at Week 24', 'timeFrame': '24 weeks', 'description': 'The percentage of participants who achieved A1C values \\<6.5% (48 mmol/mol) or \\<7.0% (53 mmol/mol) in the FAS population at Week 24.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'availIpds': [{'url': 'http://www.merck.com/clinical-trials/study.html?id=3102-022&kw=3102-022&tab=access', 'type': 'CSR Synopsis Links'}], 'references': [{'pmid': '29110647', 'type': 'RESULT', 'citation': "Lee SH, Gantz I, Round E, Latham M, O'Neill EA, Ceesay P, Suryawanshi S, Kaufman KD, Engel SS, Lai E. A randomized, placebo-controlled clinical trial evaluating the safety and efficacy of the once-weekly DPP-4 inhibitor omarigliptin in patients with type 2 diabetes mellitus inadequately controlled by glimepiride and metformin. BMC Endocr Disord. 2017 Nov 6;17(1):70. doi: 10.1186/s12902-017-0219-x."}]}, 'descriptionModule': {'briefSummary': 'This study will examine the safety and efficacy of the addition of omarigliptin in participants with type 2 diabetes mellitus with inadequate glycemic control on metformin and glimepiride. The primary hypothesis is that after 24 weeks, the addition of treatment with omarigliptin provides a greater reduction in hemoglobin A1c (A1C) compared with the addition of placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with type 2 diabetes mellitus\n* Currently taking stable doses of metformin (\\>=1500 mg/day) and sulfonylurea\n* Male, or female not of reproductive potential or female of reproductive potential who agrees to remain abstinent or use (or have their partner use) 2 methods of 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* Treated with any antihyperglycemic agent therapies other than the protocol-required sulfonylurea and metformin within 12 weeks prior to study participation or with omarigliptin at any time prior to study participation.\n* History of hypersensitivity to a dipeptidyl peptidase IV (DPP-4) inhibitor\n* 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* Is on or likely to require treatment for \\>=2 consecutive weeks or repeated courses of corticosteroids (inhaled, nasal or topical corticosteroids are permitted)\n* Currently being treated for hyperthyroidism or is on thyroid replacement therapy and has not been on a stable dose for at least 6 weeks\n* Medical history of active liver disease (other than non-alcoholic hepatic steatosis), including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease\n* Human immunodeficiency virus (HIV)\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* 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* Clinically important hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia)\n* Pregnant or breast feeding, or is expecting to conceive or donate eggs during the trial, including 21 days following the last dose of study drug\n* Current user of recreational or illicit drugs or has had a recent history of drug abuse or routinely consumes \\>2 alcoholic drinks per day or \\>14 drinks per week, or engages in binge drinking\n* Donated blood products within 8 weeks of study participation, or intends to donate blood products during the study or has received or anticipates receiving blood products within 12 weeks prior to study participation or during the study'}, 'identificationModule': {'nctId': 'NCT01704261', 'briefTitle': 'Addition of Omarigliptin (MK-3102) to Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Combination Therapy With Glimepiride and Metformin (MK-3102-022)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Study the Safety and Efficacy of the Addition of MK-3102 to Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Combination Therapy With Glimepiride and Metformin', 'orgStudyIdInfo': {'id': '3102-022'}, 'secondaryIdInfos': [{'id': '2012-002612-10', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Omarigliptin', 'description': 'Omarigliptin (MK-3102) 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose \\>=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose \\>=1500 mg per day).', 'interventionNames': ['Drug: Omarigliptin', 'Drug: Glimepiride', 'Drug: Metformin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose \\>=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose \\>=1500 mg per day).', 'interventionNames': ['Drug: Matching placebo to Omarigliptin', 'Drug: Glimepiride', 'Drug: Metformin']}], 'interventions': [{'name': 'Omarigliptin', 'type': 'DRUG', 'description': 'Omarigliptin 25 mg capsule administered orally once a week', 'armGroupLabels': ['Omarigliptin']}, {'name': 'Matching placebo to Omarigliptin', 'type': 'DRUG', 'description': 'Matching placebo to omarigliptin capsule administered orally once a week', 'armGroupLabels': ['Placebo']}, {'name': 'Glimepiride', 'type': 'DRUG', 'otherNames': ['Amaryl®', 'Glimy'], 'description': 'Open-label glimepiride tablet(s) administered orally once daily for a total daily dose \\>=4 mg. In the event of hypoglycemia, the glimepiride dose may be down-titrated to a minimum dose of 1 mg daily.', 'armGroupLabels': ['Omarigliptin', 'Placebo']}, {'name': 'Metformin', 'type': 'DRUG', 'otherNames': ['Fortamet®', 'Glucophage®', 'Glucophage® XR', 'Glumetza®', 'Riomet®'], 'description': 'Open-label metformin tablet(s) administered orally once or twice daily for a total daily dose \\>=1500 mg', 'armGroupLabels': ['Omarigliptin', 'Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director, MD', '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'}}}}