drugset / Trial / NCT01545388

Metformin Add-on Regimen Comparison Study in Japanese Participants With Type 2 Diabetes Mellitus (MK-0431A-136)

NCT01545388

Phase 3 Completed 337 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupDouble-blindTreatment

Summary

This study will evaluate the effect of the addition of metformin once daily (q.d.) or twice daily (b.i.d.) to sitagliptin monotherapy in Japanese participants with Type 2 diabetes mellitus (T2DM) who have inadequate glycemic control with diet/exercise therapy and sitagliptin monotherapy. The primary hypotheses are that the addition of metformin 250 mg b.i.d. or metformin 500 mg q.d. is superior to the addition of placebo on the change from baseline in hemoglobin A1c (HbA1c) at 24 weeks and that the addition of metformin 500 mg q.d. is non-inferior to the addition of metformin 250 mg b.i.d. on the change from baseline in HbA1c at 24 weeks.

Timeline

Start
2012-02-23
Primary completion
2013-03-12
Completion
2013-03-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Metformin Small molecule 500 mg Oral
Background Sitagliptin Small molecule 50 mg Oral
Background Sitagliptin Small molecule 100 mg Oral