Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-02-26 @ 12:38 AM
Study NCT ID:
NCT01678820
Status:
TERMINATED
Last Update Posted:
2018-08-24
First Post:
2012-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of the Efficacy and Safety of MK-0431D (a Fixed-dose Combination of Sitagliptin and Simvastatin) for the Treatment of Participants With Type 2 Diabetes Mellitus (T2DM) With Inadequate Glycemic Control on Metformin Monotherapy (MK-0431D-266)
Sponsor:
Organization:
Raw JSON
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Any information identified by the Sponsor as confidential must be deleted prior to submission.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Study was terminated for business reasons in November 2013.'}}, 'adverseEventsModule': {'timeFrame': 'Up to 18 weeks', 'description': 'All participants as treated population defined as all randomized participants who received at least one dose of study drug. Serious adverse events include data after rescue therapy and non-serious adverse events exclude data after rescue therapy.', 'eventGroups': [{'id': 'EG000', 'title': 'Sitagliptin/Simvastatin FDC', 'description': 'Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of \\>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.', 'otherNumAtRisk': 100, 'otherNumAffected': 0, 'seriousNumAtRisk': 100, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Sitagliptin', 'description': 'Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of \\>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.', 'otherNumAtRisk': 97, 'otherNumAffected': 0, 'seriousNumAtRisk': 97, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Simvastatin', 'description': 'Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of \\>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.', 'otherNumAtRisk': 98, 'otherNumAffected': 0, 'seriousNumAtRisk': 98, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Hemoglobin A1C (A1C) at Week 16 (Sitagliptin/Simvastatin FDC vs. Sitagliptin)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin/Simvastatin FDC', 'description': 'Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of \\>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.'}, {'id': 'OG001', 'title': 'Sitagliptin', 'description': 'Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of \\>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.41', 'groupId': 'OG000', 'lowerLimit': '-0.64', 'upperLimit': '-0.17'}, {'value': '-0.59', 'groupId': 'OG001', 'lowerLimit': '-0.83', 'upperLimit': '-0.36'}]}]}], 'analyses': [{'pValue': '0.267', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.19', 'ciLowerLimit': '-0.14', 'ciUpperLimit': '0.52', 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 16', 'description': 'A1C is measured as percent. 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Results for simvastatin are presented below under secondary outcome measures.', 'unitOfMeasure': 'Percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Experienced at Least One Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin/Simvastatin FDC', 'description': 'Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of \\>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.'}, {'id': 'OG001', 'title': 'Sitagliptin', 'description': 'Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of \\>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.'}, {'id': 'OG002', 'title': 'Simvastatin', 'description': 'Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. 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Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percents', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-10.2', 'ciUpperLimit': '9.3', 'estimateComment': 'Based on Miettinen \\& Nurminen method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in percents', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.3', 'ciLowerLimit': '-14.7', 'ciUpperLimit': '5.8', 'estimateComment': 'Based on Miettinen \\& Nurminen method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 16 weeks for non-serious AEs, up to 18 weeks for serious AEs', 'description': "Excludes data after rescue therapy. Adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants as treated population defined as all randomized participants who received at least one dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Discontinued Study Drug Due to an Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin/Simvastatin FDC', 'description': 'Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of \\>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.'}, {'id': 'OG001', 'title': 'Sitagliptin', 'description': 'Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of \\>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.'}, {'id': 'OG002', 'title': 'Simvastatin', 'description': 'Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of \\>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 16 weeks', 'description': "Excludes data after rescue therapy. 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Participants will continue on their stable pre-screening metformin dose and dosing regimen of \\>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.'}, {'id': 'OG001', 'title': 'Simvastatin', 'description': 'Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of \\>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.41', 'groupId': 'OG000', 'lowerLimit': '-0.64', 'upperLimit': '-0.17'}, {'value': '0.21', 'groupId': 'OG001', 'lowerLimit': '-0.02', 'upperLimit': '0.45'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.62', 'ciLowerLimit': '-0.95', 'ciUpperLimit': '-0.28', 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 16', 'description': 'A1C is measured as percent. Thus, this change from baseline reflects the Week 16 A1C percent minus the Week 0 A1C percent. This primary outcome measure only includes results for sitagliptin/simvastatin FDC vs. simvastatin. Results for sitagliptin are presented above under primary outcome measures.', 'unitOfMeasure': 'Percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose (FPG) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin/Simvastatin FDC', 'description': 'Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of \\>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.'}, {'id': 'OG001', 'title': 'Sitagliptin', 'description': 'Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of \\>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.'}, {'id': 'OG002', 'title': 'Simvastatin', 'description': 'Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of \\>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.9', 'groupId': 'OG000', 'lowerLimit': '-21.0', 'upperLimit': '5.2'}, {'value': '-9.6', 'groupId': 'OG001', 'lowerLimit': '-23.4', 'upperLimit': '4.1'}, {'value': '21.3', 'groupId': 'OG002', 'lowerLimit': '7.9', 'upperLimit': '34.7'}]}]}], 'analyses': [{'pValue': '0.856', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.7', 'ciLowerLimit': '-17.1', 'ciUpperLimit': '20.6', 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.'}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-29.2', 'ciLowerLimit': '-47.9', 'ciUpperLimit': '-10.6', 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 16', 'description': 'Change from baseline reflects the Week 16 value minus the Week 0 value.', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population defined as all randomized participants who took at least one dose of study drug and who had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin/Simvastatin FDC', 'description': 'Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of \\>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.'}, {'id': 'OG001', 'title': 'Sitagliptin', 'description': 'Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of \\>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.'}, {'id': 'OG002', 'title': 'Simvastatin', 'description': 'Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of \\>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '-21.6', 'groupId': 'OG000', 'lowerLimit': '-32.3', 'upperLimit': '-10.8'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '-6.9', 'upperLimit': '14.9'}, {'value': '-26.9', 'groupId': 'OG002', 'lowerLimit': '-37.5', 'upperLimit': '-16.3'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-25.6', 'ciLowerLimit': '-35.6', 'ciUpperLimit': '-15.6', 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.'}, {'pValue': '0.286', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.3', 'ciLowerLimit': '-4.5', 'ciUpperLimit': '15.2', 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 16', 'description': 'Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.', 'unitOfMeasure': 'Percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Total Cholesterol (TC) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin/Simvastatin FDC', 'description': 'Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of \\>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.'}, {'id': 'OG001', 'title': 'Sitagliptin', 'description': 'Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of \\>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.'}, {'id': 'OG002', 'title': 'Simvastatin', 'description': 'Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of \\>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '-18.4', 'groupId': 'OG000', 'lowerLimit': '-26.6', 'upperLimit': '-10.2'}, {'value': '-0.4', 'groupId': 'OG001', 'lowerLimit': '-8.6', 'upperLimit': '7.9'}, {'value': '-18.4', 'groupId': 'OG002', 'lowerLimit': '-26.4', 'upperLimit': '-10.4'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-18.1', 'ciLowerLimit': '-24.2', 'ciUpperLimit': '-12.0', 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.'}, {'pValue': '0.990', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0', 'ciLowerLimit': '-6.0', 'ciUpperLimit': '6.0', 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 16', 'description': 'Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.', 'unitOfMeasure': 'Percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin/Simvastatin FDC', 'description': 'Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of \\>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.'}, {'id': 'OG001', 'title': 'Sitagliptin', 'description': 'Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of \\>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.'}, {'id': 'OG002', 'title': 'Simvastatin', 'description': 'Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of \\>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '-16.9', 'groupId': 'OG000', 'lowerLimit': '-27.0', 'upperLimit': '-6.8'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '-7.1', 'upperLimit': '13.7'}, {'value': '-19.8', 'groupId': 'OG002', 'lowerLimit': '-30.0', 'upperLimit': '-9.6'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-20.2', 'ciLowerLimit': '-28.3', 'ciUpperLimit': '-12.2', 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.'}, {'pValue': '0.469', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.9', 'ciLowerLimit': '-5.0', 'ciUpperLimit': '10.7', 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 16', 'description': 'Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.', 'unitOfMeasure': 'Percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Non-high Density Lipoprotein Cholesterol (Non-HDL-C) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin/Simvastatin FDC', 'description': 'Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of \\>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.'}, {'id': 'OG001', 'title': 'Sitagliptin', 'description': 'Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of \\>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.'}, {'id': 'OG002', 'title': 'Simvastatin', 'description': 'Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of \\>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '-23.9', 'groupId': 'OG000', 'lowerLimit': '-33.9', 'upperLimit': '-13.9'}, {'value': '0.6', 'groupId': 'OG001', 'lowerLimit': '-9.5', 'upperLimit': '10.7'}, {'value': '-24.2', 'groupId': 'OG002', 'lowerLimit': '-34.0', 'upperLimit': '-14.4'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-24.4', 'ciLowerLimit': '-32.6', 'ciUpperLimit': '-16.3', 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.'}, {'pValue': '0.937', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-7.7', 'ciUpperLimit': '8.3', 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 16', 'description': 'Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.', 'unitOfMeasure': 'Percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Triglycerides (TG) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin/Simvastatin FDC', 'description': 'Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of \\>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.'}, {'id': 'OG001', 'title': 'Sitagliptin', 'description': 'Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of \\>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.'}, {'id': 'OG002', 'title': 'Simvastatin', 'description': 'Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of \\>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '-20.4', 'groupId': 'OG000', 'lowerLimit': '-51.9', 'upperLimit': '11.1'}, {'value': '-4.9', 'groupId': 'OG001', 'lowerLimit': '-39.5', 'upperLimit': '29.7'}, {'value': '-10.1', 'groupId': 'OG002', 'lowerLimit': '-52.1', 'upperLimit': '31.9'}]}]}], 'analyses': [{'pValue': '0.068', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in estimated means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.5', 'ciLowerLimit': '-32.2', 'ciUpperLimit': '1.2', 'statisticalMethod': 'Robust regression', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Using M-estimation with treatment, region, and a covariate for baseline triglycerides (mg/dL). Missing data were imputed by multiple imputations.'}, {'pValue': '0.365', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in estimated means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.3', 'ciLowerLimit': '-33.6', 'ciUpperLimit': '13.0', 'statisticalMethod': 'Robust regression', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Using M-estimation with treatment, region, and a covariate for baseline triglycerides (mg/dL). Missing data were imputed by multiple imputations.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 16', 'description': 'Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.', 'unitOfMeasure': 'Percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin/Simvastatin FDC', 'description': 'Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of \\>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.'}, {'id': 'OG001', 'title': 'Sitagliptin', 'description': 'Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of \\>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.'}, {'id': 'OG002', 'title': 'Simvastatin', 'description': 'Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of \\>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000', 'lowerLimit': '-2.7', 'upperLimit': '7.8'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '-3.3', 'upperLimit': '7.4'}, {'value': '2.1', 'groupId': 'OG002', 'lowerLimit': '-3.0', 'upperLimit': '7.3'}]}]}], 'analyses': [{'pValue': '0.857', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-4.8', 'ciUpperLimit': '5.8', 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.'}, {'pValue': '0.879', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-4.8', 'ciUpperLimit': '5.6', 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 16', 'description': 'Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.', 'unitOfMeasure': 'Percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin/Simvastatin FDC', 'description': 'Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of \\>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.'}, {'id': 'OG001', 'title': 'Sitagliptin', 'description': 'Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of \\>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.'}, {'id': 'OG002', 'title': 'Simvastatin', 'description': 'Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of \\>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '-17.5', 'groupId': 'OG000', 'lowerLimit': '-33.8', 'upperLimit': '-1.2'}, {'value': '12.9', 'groupId': 'OG001', 'lowerLimit': '-4.2', 'upperLimit': '29.9'}, {'value': '-2.2', 'groupId': 'OG002', 'lowerLimit': '-18.9', 'upperLimit': '14.5'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-30.4', 'ciLowerLimit': '-51.0', 'ciUpperLimit': '-9.7', 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.'}, {'pValue': '0.141', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.3', 'ciLowerLimit': '-35.8', 'ciUpperLimit': '5.1', 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 16', 'description': 'Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.', 'unitOfMeasure': 'Percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With A1C Level <7% at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin/Simvastatin FDC', 'description': 'Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of \\>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.'}, {'id': 'OG001', 'title': 'Sitagliptin', 'description': 'Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of \\>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.'}, {'id': 'OG002', 'title': 'Simvastatin', 'description': 'Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of \\>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.9', 'groupId': 'OG000'}, {'value': '29.6', 'groupId': 'OG001'}, {'value': '17.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percents', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-12.2', 'ciUpperLimit': '12.9', 'estimateComment': 'Based on Miettinen \\& Nurminen method. Missing data were imputed by multiple impuattions.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in percents', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.3', 'ciLowerLimit': '0.7', 'ciUpperLimit': '24.0', 'estimateComment': 'Based on Miettinen \\& Nurminen method. Missing data were imputed by multiple imputations.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'Percentage of participants achieving glycemic goal (A1C \\<7%) after 16 weeks of treatment. Data as observed.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sitagliptin/Simvastatin FDC', 'description': 'Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of \\>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.'}, {'id': 'FG001', 'title': 'Sitagliptin', 'description': 'Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of \\>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.'}, {'id': 'FG002', 'title': 'Simvastatin', 'description': 'Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of \\>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '99'}, {'groupId': 'FG002', 'numSubjects': '100'}]}, {'type': 'Treated With Double-blind Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '97'}, {'groupId': 'FG002', 'numSubjects': '98'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '36'}, {'groupId': 'FG002', 'numSubjects': '43'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '63'}, {'groupId': 'FG002', 'numSubjects': '57'}]}], 'dropWithdraws': [{'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '43'}, {'groupId': 'FG002', 'numSubjects': '43'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Protocol Specified Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Non-compliance with study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Not treated with double-blind study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'All participants randomized population.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}, {'value': '299', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Sitagliptin/Simvastatin FDC', 'description': 'Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of \\>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.'}, {'id': 'BG001', 'title': 'Sitagliptin', 'description': 'Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of \\>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.'}, {'id': 'BG002', 'title': 'Simvastatin', 'description': 'Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of \\>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.9', 'spread': '10.2', 'groupId': 'BG000'}, {'value': '54.2', 'spread': '10.3', 'groupId': 'BG001'}, {'value': '54.9', 'spread': '10.0', 'groupId': 'BG002'}, {'value': '54.7', 'spread': '10.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '146', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '153', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hemoglobin A1c (A1C)', 'classes': [{'categories': [{'measurements': [{'value': '8.16', 'spread': '0.94', 'groupId': 'BG000'}, {'value': '8.15', 'spread': '1.09', 'groupId': 'BG001'}, {'value': '8.22', 'spread': '1.19', 'groupId': 'BG002'}, {'value': '8.18', 'spread': '1.08', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percent', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting plasma glucose (FPG)', 'classes': [{'categories': [{'measurements': [{'value': '169.9', 'spread': '42.3', 'groupId': 'BG000'}, {'value': '175.9', 'spread': '48.6', 'groupId': 'BG001'}, {'value': '175.7', 'spread': '49.3', 'groupId': 'BG002'}, {'value': '173.8', 'spread': '46.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Low-density lipoprotein cholesterol (LDL-C)', 'classes': [{'categories': [{'measurements': [{'value': '106.5', 'spread': '26.7', 'groupId': 'BG000'}, {'value': '103.9', 'spread': '24.2', 'groupId': 'BG001'}, {'value': '100.9', 'spread': '22.0', 'groupId': 'BG002'}, {'value': '103.7', 'spread': '24.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total cholesterol (TC)', 'classes': [{'categories': [{'measurements': [{'value': '189.3', 'spread': '30.9', 'groupId': 'BG000'}, {'value': '187.7', 'spread': '29.6', 'groupId': 'BG001'}, {'value': '183.5', 'spread': '28.4', 'groupId': 'BG002'}, {'value': '186.8', 'spread': '29.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Apolipoprotein B (Apo B)', 'classes': [{'categories': [{'measurements': [{'value': '97.8', 'spread': '19.0', 'groupId': 'BG000'}, {'value': '95.4', 'spread': '19.0', 'groupId': 'BG001'}, {'value': '94.1', 'spread': '17.2', 'groupId': 'BG002'}, {'value': '95.8', 'spread': '18.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Sitagliptin, n=95; Total, n=295', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Non high-density lipoprotein cholesterol (non-HDL-C)', 'classes': [{'categories': [{'measurements': [{'value': '141.7', 'spread': '30.9', 'groupId': 'BG000'}, {'value': '139.5', 'spread': '29.9', 'groupId': 'BG001'}, {'value': '136.5', 'spread': '27.1', 'groupId': 'BG002'}, {'value': '139.2', 'spread': '29.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Sitagliptin, n=97; Total, n=297', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Triglycerides (TG)', 'classes': [{'categories': [{'measurements': [{'value': '177.4', 'spread': '101.2', 'groupId': 'BG000'}, {'value': '180.8', 'spread': '119.1', 'groupId': 'BG001'}, {'value': '184.2', 'spread': '118.6', 'groupId': 'BG002'}, {'value': '180.8', 'spread': '112.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'High-density lipoprotein cholesterol (HDL-C)', 'classes': [{'categories': [{'measurements': [{'value': '47.6', 'spread': '11.3', 'groupId': 'BG000'}, {'value': '48.2', 'spread': '12.1', 'groupId': 'BG001'}, {'value': '47.0', 'spread': '11.2', 'groupId': 'BG002'}, {'value': '47.6', 'spread': '11.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Very low-density lipoprotein cholesterol (VLDL-C)', 'classes': [{'categories': [{'measurements': [{'value': '35.4', 'spread': '18.8', 'groupId': 'BG000'}, {'value': '35.8', 'spread': '20.4', 'groupId': 'BG001'}, {'value': '35.7', 'spread': '18.8', 'groupId': 'BG002'}, {'value': '35.6', 'spread': '19.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Sitagliptin, n=97; Total, n=297', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All participants randomized population. Study specific baseline characteristics include all randomized participants with data.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 299}}, 'statusModule': {'whyStopped': 'Merck terminated the study for business reasons in November 2013.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2013-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-25', 'studyFirstSubmitDate': '2012-08-31', 'resultsFirstSubmitDate': '2014-10-16', 'studyFirstSubmitQcDate': '2012-08-31', 'lastUpdatePostDateStruct': {'date': '2018-08-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-10-16', 'studyFirstPostDateStruct': {'date': '2012-09-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Hemoglobin A1C (A1C) at Week 16 (Sitagliptin/Simvastatin FDC vs. Sitagliptin)', 'timeFrame': 'Baseline and Week 16', 'description': 'A1C is measured as percent. Thus, this change from baseline reflects the Week 16 A1C percent minus the Week 0 A1C percent. This primary outcome measure only includes results for sitagliptin/simvastatin FDC vs. sitagliptin. Results for simvastatin are presented below under secondary outcome measures.'}, {'measure': 'Number of Participants Who Experienced at Least One Adverse Event (AE)', 'timeFrame': 'Up to 16 weeks for non-serious AEs, up to 18 weeks for serious AEs', 'description': "Excludes data after rescue therapy. Adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product."}, {'measure': 'Number of Participants Who Discontinued Study Drug Due to an Adverse Event', 'timeFrame': 'Up to 16 weeks', 'description': "Excludes data after rescue therapy. Adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product."}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in A1C at Week 16 (Sitagliptin/Simvastatin FDC vs. Simvastatin)', 'timeFrame': 'Baseline and Week 16', 'description': 'A1C is measured as percent. Thus, this change from baseline reflects the Week 16 A1C percent minus the Week 0 A1C percent. This primary outcome measure only includes results for sitagliptin/simvastatin FDC vs. simvastatin. Results for sitagliptin are presented above under primary outcome measures.'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose (FPG) at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'Change from baseline reflects the Week 16 value minus the Week 0 value.'}, {'measure': 'Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.'}, {'measure': 'Percent Change From Baseline in Total Cholesterol (TC) at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.'}, {'measure': 'Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.'}, {'measure': 'Percent Change From Baseline in Non-high Density Lipoprotein Cholesterol (Non-HDL-C) at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.'}, {'measure': 'Percent Change From Baseline in Triglycerides (TG) at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.'}, {'measure': 'Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.'}, {'measure': 'Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.'}, {'measure': 'Percentage of Participants With A1C Level <7% at Week 16', 'timeFrame': 'Week 16', 'description': 'Percentage of participants achieving glycemic goal (A1C \\<7%) after 16 weeks of treatment. Data as observed.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'availIpds': [{'url': 'http://www.merck.com/clinical-trials/study.html?id=0431D-266&kw=0431D-266&tab=access', 'type': 'CSR Synopsis'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy and safety of sitagliptin/simvastatin fixed-dose combination (FDC) in participants with T2DM who have inadequate glycemic control while on metformin monotherapy. The primary hypothesis of this study is that after 16 weeks of therapy, the mean change from baseline in hemoglobin A1C (A1C) in participants treated with sitagliptin/simvastatin FDC is non-inferior compared to sitagliptin alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* has T2DM\n* (1) Male; (2) female not of reproductive potential; or (3) female of reproductive potential who agrees to remain abstinent or use alone or in conjunction with their partner 2 methods of contraception to prevent pregnancy during the study and for 14 days after the last dose of study drug\n* is currently on metformin monotherapy at a daily dose of at least 1500 mg for at least 10 weeks\n* is not on a lipid-lowering agent for at least 6 weeks prior to entering the study\n\nExclusion Criteria:\n\n* has history of type 1 diabetes mellitus (T1DM), or a history of ketoacidosis or possibly has T1DM\n* has been on a thiazolidinedione (TZD) within the previous 16 weeks\n* has been treated with a statin or other lipid-lowering agent (including over-the-counter \\[OTC\\] supplements) within the previous 6 weeks\n* currently participating in or has participated in another clinical study within the past 12 weeks\n* intends to consume \\>1.2 liters of grapefruit juice daily during the study\n* is on or likely to require treatment for at least 2 consecutive weeks or repeated courses of corticosteroids (inhaled, nasal and topical corticosteroids are permitted)\n* intolerance or hypersensitivity to sitagliptin, simvastatin, metformin or glimepiride\n* is on a weight loss program and not in the maintenance phase or has started a weight loss medication or has undergone bariatric surgery in the previous 12 months\n* has undergone a surgical procedure in the past 4 weeks or planned major surgery during the study\n* has symptomatic hyperglycemia that requires immediate initiation, adjustment, or addition of antihyperglycemic therapy\n* has a history of myopathy or rhabdomyolysis with any statin\n* has cardiovascular disease, a diagnosis of congestive heart failure, or uncontrolled high blood pressure\n* has a history of active liver disease\n* has chronic progressive neuromuscular disorder, human immunodeficiency virus (HIV), hematological disorder, or uncontrolled endocrine or metabolic disease\n* is currently being treated for hyperthyroidism or is on thyroid hormone therapy and has not been on a stable dose for at least 6 weeks\n* has a history of malignancy in the previous 5 years (excluding adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer)\n* is pregnant or breast feeding, or is expecting to conceive or donate eggs during the course of the study, including 14 days after the last dose of study drug\n* is a user of recreational or illicit drugs or has had a recent history of drug abuse\n* consumes \\>2 alcoholic drinks per day or \\>14 alcoholic drinks per week, or engages in binge drinking'}, 'identificationModule': {'nctId': 'NCT01678820', 'briefTitle': 'A Study of the Efficacy and Safety of MK-0431D (a Fixed-dose Combination of Sitagliptin and Simvastatin) for the Treatment of Participants With Type 2 Diabetes Mellitus (T2DM) With Inadequate Glycemic Control on Metformin Monotherapy (MK-0431D-266)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase III, Randomized, Double-blind, Clinical Trial to Study the Efficacy and Safety of MK-0431D (a Fixed-dose Combination [FDC] of Sitagliptin and Simvastatin) for the Treatment of Patients With Type 2 Diabetes Mellitus (T2DM) With Inadequate Glycemic Control on Metformin Monotherapy', 'orgStudyIdInfo': {'id': '0431D-266'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sitagliptin/Simvastatin FDC', 'description': 'Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening for 16 weeks. Participants will continue on their stable pre-screening metformin dose and dosing regimen of \\>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.', 'interventionNames': ['Drug: Sitagliptin/Simvastatin FDC', 'Drug: Placebo to sitagliptin', 'Drug: Placebo to simvastatin', 'Drug: Metformin', 'Drug: Glimepiride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sitagliptin', 'description': 'Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening for 16 weeks. Participants will continue on their stable pre-screening metformin dose and dosing regimen of \\>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.', 'interventionNames': ['Drug: Sitagliptin', 'Drug: Placebo to simvastatin', 'Drug: Placebo to Sitagliptin/Simvastatin FDC', 'Drug: Metformin', 'Drug: Glimepiride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Simvastatin', 'description': 'Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening for 16 weeks. Participants will continue on their stable pre-screening metformin dose and dosing regimen of \\>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.', 'interventionNames': ['Drug: Simvastatin', 'Drug: Placebo to sitagliptin', 'Drug: Placebo to Sitagliptin/Simvastatin FDC', 'Drug: Metformin', 'Drug: Glimepiride']}], 'interventions': [{'name': 'Sitagliptin/Simvastatin FDC', 'type': 'DRUG', 'otherNames': ['MK-0431D', 'Juvisync™', 'Juvicor®'], 'description': 'Sitagliptin 100 mg/Simvastatin 40 mg fixed-dose combination tablet', 'armGroupLabels': ['Sitagliptin/Simvastatin FDC']}, {'name': 'Sitagliptin', 'type': 'DRUG', 'otherNames': ['MK-0431', 'Januvia®', 'Tesavel®', 'Xelevia®', 'Ristaben®'], 'description': 'Sitagliptin 100 mg tablet', 'armGroupLabels': ['Sitagliptin']}, {'name': 'Simvastatin', 'type': 'DRUG', 'otherNames': ['MK-0733', 'Zocor®'], 'description': 'Simvastatin 40 mg tablet', 'armGroupLabels': ['Simvastatin']}, {'name': 'Placebo to sitagliptin', 'type': 'DRUG', 'description': 'Matching placebo to sitagliptin 100 mg tablet', 'armGroupLabels': ['Simvastatin', 'Sitagliptin/Simvastatin FDC']}, {'name': 'Placebo to simvastatin', 'type': 'DRUG', 'description': 'Matching placebo to simvastatin 40 mg tablet', 'armGroupLabels': ['Sitagliptin', 'Sitagliptin/Simvastatin FDC']}, {'name': 'Placebo to Sitagliptin/Simvastatin FDC', 'type': 'DRUG', 'description': 'Matching placebo to sitagliptin 100 mg/simvastatin 40 mg FDC tablet', 'armGroupLabels': ['Simvastatin', 'Sitagliptin']}, {'name': 'Metformin', 'type': 'DRUG', 'otherNames': ['Fortamet®', 'Glucophage®', 'Glucophage® XR', 'Glumetza®', 'Riomet®', 'Metgluco®', 'Glycoran®'], 'description': 'Participants will continue on their stable, pre-screening metformin daily dose of \\>= 1500 mg for at least 12 weeks prior to randomization and during the study', 'armGroupLabels': ['Simvastatin', 'Sitagliptin', 'Sitagliptin/Simvastatin FDC']}, {'name': 'Glimepiride', 'type': 'DRUG', 'otherNames': ['Amaryl®', 'Glimy'], 'description': 'Following randomization, participants requiring glycemic rescue may receive open-label glimepiride initiated at a dose of 1 mg/day or 2 mg/day which may be up-titrated to 6 mg/day taken once daily with breakfast or the first main meal of the day.', 'armGroupLabels': ['Simvastatin', 'Sitagliptin', 'Sitagliptin/Simvastatin FDC']}]}, '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'}}}}