CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 292 enrolled
Drug / intervention
Sitagliptin/Metformin FDC +3 moredrug
Likely dose
Sitagliptin/Metformin FDC 1000 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00993187
NCT00993187Phase 4Completed
CompareCT.gov

A Multicenter, Randomized, Double Blind Study to Compare the Efficacy and Safety of Sitagliptin/Metformin Fixed-Dose Combination (Janumet®) Compared to Glimepiride in Patients With Type 2 Diabetes Mellitus

Merck Sharp & Dohme LLC·interventional·Posted Oct 12, 2009·Updated Aug 22, 2018

In Brief

A Phase 4 clinical trial evaluating Sitagliptin/Metformin FDC, Comparator: Glimepiride, and 2 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 292 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 12, 2009
Enrollment StartMay 4, 2010
Primary CompletionOct 29, 2013
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 16.7 years ago

Interventions

Sitagliptin/Metformin FDCdrug

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

Comparator: Glimepiridedrug

Glimepiride tablet orally up to 6 mg daily for 30 Weeks

Matching placebo to Sitagliptin/Metformin FDCdrug

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

Matching placebo to glimepiridedrug

Matching placebo to glimepiride tablet orally daily for 30 weeks