drugset / Trial / NCT00701090

A Study to Test the Safety and Efficacy of Sitagliptin Compared to Glimepiride in Patients With Type 2 Diabetes on a Stable Dose of Metformin (0431-803)(COMPLETED)

NCT00701090 ↗

Phase 3 Completed 1035 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupDouble-blindTreatment

Summary

A study to see if better control of type 2 diabetes can occur in patients taking a stable dose of metformin when they are also provided either sitagliptin or glimepiride. This study will also see if this treatment is safe and tolerable.

Timeline

Start
2008-05
Primary completion
2009-10
Completion
2009-10

Outcome

Met primary endpoint

paper This result met the prespecified criterion for declaring non-inferiority. PMID 21199268 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Glimepiride Small molecule 6 mg —
Subject Sitagliptin Small molecule 100 mg —
Background Metformin Small molecule 1500 mg Oral