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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)

NCT01678820 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 299

Last updated 2018-08-24

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Sitagliptin/Simvastatin FDC

Sitagliptin 100 mg/Simvastatin 40 mg fixed-dose combination tablet

DRUG

Sitagliptin

Sitagliptin 100 mg tablet

DRUG

Simvastatin

Simvastatin 40 mg tablet

DRUG

Placebo to sitagliptin

Matching placebo to sitagliptin 100 mg tablet

DRUG

Placebo to simvastatin

Matching placebo to simvastatin 40 mg tablet

DRUG

Placebo to Sitagliptin/Simvastatin FDC

Matching placebo to sitagliptin 100 mg/simvastatin 40 mg FDC tablet

DRUG

Metformin

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

DRUG

Glimepiride

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.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-10
Primary Completion
2013-11-01
Completion
2013-11-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01678820 on ClinicalTrials.gov