At a glance
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A Phase III, Randomized, Placebo and Active-Controlled, Double-Blind Clinical Trial to Study the Efficacy and Safety of the Addition of Metformin in Japanese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy and Sitagliptin Monotherapy
In Brief
A Phase 3 clinical trial evaluating Sitagliptin, Metformin, and 1 other intervention for Type 2 Diabetes Mellitus. Completed, enrolled 337 participants.
Detailed 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.
Study Details
Timeline
Interventions
Sitagliptin, orally, 50 or 100 mg tablet (continuation of the pre-study dose)
Metformin, orally, 500 mg daily (single dose; two 250 mg tablets) for 24 weeks
Metformin, orally, 500 mg daily (divided dose; 250 mg tablet b.i.d.) for 24 weeks
Placebo to match metformin 250 mg tablets, orally, for 24 weeks