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Efficacy and Safety of Sitagliptin/Metformin Fixed-Dose Combination (FDC) Compared to Glimepiride in Participants With Type 2 Diabetes Mellitus (MK-0431A-202)

NCT00993187 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 292

Last updated 2018-08-22

Study results available
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Summary

This study will assess the effect of sitagliptin/metformin FDC 50/1000 mg (Janumet®), MK-0431A) compared with the effect of glimepiride on hemoglobin A1c (HbA1c). The primary hypothesis is that after 30 weeks, sitagliptin/metformin FDC 50/1000 mg provides superior reduction in HbA1c (mean change from baseline) compared to glimepiride.

Conditions

Interventions

DRUG

Sitagliptin/Metformin FDC

Sitagliptin phosphate plus metformin hydrochloride combination tablet (MK-0431A) orally up to 50/1000 mg BID for 30 weeks

DRUG

Comparator: Glimepiride

Glimepiride tablet orally up to 6 mg daily for 30 Weeks

DRUG

Matching placebo to Sitagliptin/Metformin FDC

Matching placebo to Sitagliptin/Metformin FDC 50/1000 mg orally BID for 30 weeks

DRUG

Matching placebo to glimepiride

Matching placebo to glimepiride tablet orally daily for 30 weeks

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-04
Primary Completion
2013-10-29
Completion
2013-10-29

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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 NCT00993187 on ClinicalTrials.gov