Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 10:43 PM
Study NCT ID:
NCT01863667
Status:
TERMINATED
Last Update Posted:
2018-09-10
First Post:
2013-05-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Safety and Efficacy of Omarigliptin (MK-3102) Compared With Glimepiride in Participants With Type 2 Diabetes Mellitus for Whom Metformin is Inappropriate (MK-3102-027)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Austria', 'Belgium', 'Bulgaria', 'Estonia', 'Germany', 'Hungary', 'Italy', 'Poland', 'Russia', 'Serbia', 'Slovakia', 'Spain', 'Ukraine', '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'}]}}, '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.\n\nAny 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}, 'limitationsAndCaveats': {'description': 'The study was terminated based on business decisions only, and not due to any unexpected safety or efficacy concerns.'}}, 'adverseEventsModule': {'timeFrame': 'Up to 57 weeks (including 3 weeks following last dose of study drug)', 'description': 'All participants as treated defined as all randomized participants who received at least one dose of study drug and were included in the treatment group corresponding to the study drug they actually received.', 'eventGroups': [{'id': 'EG000', 'title': 'Omarigliptin', 'description': 'Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.', 'otherNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Glimepiride', 'description': 'Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.', 'otherNumAtRisk': 32, 'otherNumAffected': 0, 'seriousNumAtRisk': 32, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, '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 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omarigliptin', 'description': 'Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.'}, {'id': 'OG001', 'title': 'Glimepiride', 'description': 'Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.'}], 'timeFrame': 'Baseline and Week 54', 'description': 'A1C is measured as a percent. Thus, this change from baseline reflects the Week 54 A1C percent minus the Week 0 A1C percent.', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set defined as all participants who received at least one dose of study drug and had a baseline measurement or a post-randomization measurement. Due to the early termination of the study, no participants completed Week 54.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Experienced at Least One Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omarigliptin', 'description': 'Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.'}, {'id': 'OG001', 'title': 'Glimepiride', 'description': 'Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000'}, {'value': '15.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 57 weeks (including 3 weeks following the last dose of study drug)', 'description': 'An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of pre-existing conditions.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants as treated defined as all randomized participants who received at least one dose of study drug and were included in the treatment group corresponding to the study drug they actually received.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omarigliptin', 'description': 'Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.'}, {'id': 'OG001', 'title': 'Glimepiride', 'description': 'Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 54 weeks', 'description': 'An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of pre-existing conditions.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants as treated defined as all randomized participants who received at least one dose of study drug and were included in the treatment group corresponding to the study drug they actually received.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose (FPG) at Week 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omarigliptin', 'description': 'Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.'}, {'id': 'OG001', 'title': 'Glimepiride', 'description': 'Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.'}], 'timeFrame': 'Baseline and Week 54', 'description': 'This change from baseline reflects the FPG level at Week 54 minus the FPG level at Week 0.', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set defined as all participants who received at least one dose of study drug and had a baseline measurement or a post-randomization measurement. Due to the early termination of the study, no participants completed Week 54.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving an A1C Goal <7.0% or <6.5% After 54 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omarigliptin', 'description': 'Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.'}, {'id': 'OG001', 'title': 'Glimepiride', 'description': 'Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.'}], 'timeFrame': '54 weeks', 'description': 'Percentage of participants achieving glycemic goal (A1C \\<7% or \\<6.5%) after 54 weeks of treatment.', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set defined as all participants who received at least one dose of study drug and had a baseline measurement or a post-randomization measurement. Due to the early termination of the study, no participants completed Week 54.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Meeting the Composite Endpoint of an A1C Decrease >0.5%, No Symptomatic Hypoglycemia, and No Body Weight Gain After 54 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omarigliptin', 'description': 'Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.'}, {'id': 'OG001', 'title': 'Glimepiride', 'description': 'Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.'}], 'timeFrame': '54 weeks', 'description': 'Percentage of Participants who had an A1C decrease \\>0.5%, no symptomatic hypoglycemia, and no body weight gain after 54 weeks of treatment', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set defined as all participants who received at least one dose of study drug and had a baseline measurement or a post-randomization measurement. Due to the early termination of the study, no participants completed Week 54.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With an Adverse Event of Symptomatic Hypoglycemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omarigliptin', 'description': 'Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.'}, {'id': 'OG001', 'title': 'Glimepiride', 'description': 'Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.'}], 'timeFrame': 'Up to 54 weeks', 'description': 'An adverse event (AE) is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions. Per protocol, an adverse event was defined as symptomatic hypoglycemia if hypoglycemia was an adverse event collected on the AE form AND the symptoms associated with it were collected on the hypoglycemia assessment (HA) form. Due to the early termination of the study, the HA form information was not assessed; therefore, this endpoint cannot be reported.', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants as treated defined as all randomized participants who received at least one dose of study drug and were included in the treatment group corresponding to the study drug they actually received.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Weight at Week 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omarigliptin', 'description': 'Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.'}, {'id': 'OG001', 'title': 'Glimepiride', 'description': 'Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.'}], 'timeFrame': 'Baseline and Week 54', 'description': 'Body weight was to be measured (in duplicate) using a calibrated digital scale.', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants as treated defined as all randomized participants who received at least one dose of study drug and were included in the treatment group corresponding to the study drug they actually received. Due to the early termination of the study, no participants completed Week 54.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Omarigliptin', 'description': 'Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.'}, {'id': 'FG001', 'title': 'Glimepiride', 'description': 'Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '32'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Study terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'The study had a 1-week Screening Period; an oral antihyperglycemic agent (AHA) "wash-off" period of 8 weeks for participants on oral AHAs; a 2-week single-blind placebo run-in period; and a 54-week double-blind treatment period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Omarigliptin', 'description': 'Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.'}, {'id': 'BG001', 'title': 'Glimepiride', 'description': 'Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.0', 'spread': '14.1', 'groupId': 'BG000'}, {'value': '56.8', 'spread': '9.9', 'groupId': 'BG001'}, {'value': '57.4', 'spread': '12.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-07-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2014-04-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-09', 'studyFirstSubmitDate': '2013-05-23', 'resultsFirstSubmitDate': '2015-09-29', 'studyFirstSubmitQcDate': '2013-05-23', 'lastUpdatePostDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-12-15', 'studyFirstPostDateStruct': {'date': '2013-05-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-01-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Hemoglobin A1C (A1C) at Week 54', 'timeFrame': 'Baseline and Week 54', 'description': 'A1C is measured as a percent. Thus, this change from baseline reflects the Week 54 A1C percent minus the Week 0 A1C percent.'}, {'measure': 'Percentage of Participants Who Experienced at Least One Adverse Event', 'timeFrame': 'Up to 57 weeks (including 3 weeks following the last dose of study drug)', 'description': 'An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of pre-existing conditions.'}, {'measure': 'Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event', 'timeFrame': 'Up to 54 weeks', 'description': 'An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of pre-existing conditions.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Fasting Plasma Glucose (FPG) at Week 54', 'timeFrame': 'Baseline and Week 54', 'description': 'This change from baseline reflects the FPG level at Week 54 minus the FPG level at Week 0.'}, {'measure': 'Percentage of Participants Achieving an A1C Goal <7.0% or <6.5% After 54 Weeks of Treatment', 'timeFrame': '54 weeks', 'description': 'Percentage of participants achieving glycemic goal (A1C \\<7% or \\<6.5%) after 54 weeks of treatment.'}, {'measure': 'Percentage of Participants Meeting the Composite Endpoint of an A1C Decrease >0.5%, No Symptomatic Hypoglycemia, and No Body Weight Gain After 54 Weeks of Treatment', 'timeFrame': '54 weeks', 'description': 'Percentage of Participants who had an A1C decrease \\>0.5%, no symptomatic hypoglycemia, and no body weight gain after 54 weeks of treatment'}, {'measure': 'Percentage of Participants With an Adverse Event of Symptomatic Hypoglycemia', 'timeFrame': 'Up to 54 weeks', 'description': 'An adverse event (AE) is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions. Per protocol, an adverse event was defined as symptomatic hypoglycemia if hypoglycemia was an adverse event collected on the AE form AND the symptoms associated with it were collected on the hypoglycemia assessment (HA) form. Due to the early termination of the study, the HA form information was not assessed; therefore, this endpoint cannot be reported.'}, {'measure': 'Change From Baseline in Body Weight at Week 54', 'timeFrame': 'Baseline and Week 54', 'description': 'Body weight was to be measured (in duplicate) using a calibrated digital scale.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'availIpds': [{'url': 'http://www.merck.com/clinical-trials/study.html?id=3102-027&kw=3102-027&tab=access', 'type': 'CSR Synopsis Link'}]}, '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 who are metformin intolerant or who have a contraindication to the use of metformin. The primary hypothesis 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* Have intolerability to metformin ≥1000 mg/day or have a contraindication to the use of metformin\n* Females of reproductive potential agree to remain abstinent or use or have their partner use 2 acceptable methods of birth control\n\nExclusion Criteria:\n\n* History of type 1 diabetes mellitus or a history of ketoacidosis or assessed by the investigator as possibly having type 1 diabetes\n* Has been treated with:\n\n 1. A thiazolidinedione (TZD) within 4 months of study participation, or\n 2. A glucagon-like peptide-1 (GLP-1) receptor mimetic or agonist (such as exenatide or liraglutide) within 6 months of study participation, or\n 3. Insulin within 12 weeks prior to study participation, or\n 4. Dual antihyperglycemic agent (AHA) therapy within 12 weeks of study participation (4 months if a component of the dual AHA therapy was a TZD)\n 5. Omarigliptin (MK-3102) at any time prior to study participation\n* On a weight loss program and is not in the maintenance phase; has started a weight loss medication in the past 6 months; or has undergone bariatric surgery within 12 months prior to study participation\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* 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'}, 'identificationModule': {'nctId': 'NCT01863667', 'briefTitle': 'A Study to Evaluate the Safety and Efficacy of Omarigliptin (MK-3102) Compared With Glimepiride in Participants With Type 2 Diabetes Mellitus for Whom Metformin is Inappropriate (MK-3102-027)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase III, Multicenter, Double-Blind, Randomized Trial to Evaluate the Safety and Efficacy of MK-3102 Compared With Glimepiride in Subjects With Type 2 Diabetes Mellitus For Whom Metformin is Inappropriate Due to Intolerance or Contraindication', 'orgStudyIdInfo': {'id': '3102-027'}, 'secondaryIdInfos': [{'id': '2013-000301-23', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Omarigliptin', 'description': 'Participants receive an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.', 'interventionNames': ['Drug: Omarigliptin', 'Drug: Glimepiride Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Glimepiride', 'description': 'Participants receive glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.', 'interventionNames': ['Drug: Glimepiride', 'Drug: Omarigliptin Placebo']}], 'interventions': [{'name': 'Omarigliptin', 'type': 'DRUG', 'description': 'Omarigliptin (MK-3102) 25 mg capsule administered orally once weekly', 'armGroupLabels': ['Omarigliptin']}, {'name': 'Glimepiride', 'type': 'DRUG', 'otherNames': ['AMARYL®', 'GLIMY'], 'description': 'Glimepiride tablet 1 mg and/or 2 mg (uptitrated to a maximum dose 6 mg/day) administered orally once daily with breakfast or the first main meal', 'armGroupLabels': ['Glimepiride']}, {'name': 'Omarigliptin Placebo', 'type': 'DRUG', 'description': 'Matching placebo to omarigliptin capsule administered orally once weekly', 'armGroupLabels': ['Glimepiride']}, {'name': 'Glimepiride Placebo', 'type': 'DRUG', 'description': 'Matching placebo to glimepiride tablet administered orally once daily with breakfast or the first main meal', 'armGroupLabels': ['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'}}}}