Metformin Add-on Regimen Comparison Study in Japanese Participants With Type 2 Diabetes Mellitus (MK-0431A-136)
Status:
Completed
Trial end date:
2013-03-12
Target enrollment:
Participant gender:
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.