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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
337
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
Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c)
Based on a constrained longitudinal data analysis (cLDA) model with terms for treatment, other prior antihyperglycemic agent (AHA) therapy status other than sitagliptin (yes/no), study drug regimen (just before meal/after meal), sitagliptin dosage (50 mg/100 mg), time and the interaction of time by treatment, time by other prior AHA therapy status, time by study drug regimen, time by sitagliptin dosage and study drug regimen by sitagliptin dosage, with a constraint that the mean baseline is the same for all treatment groups.
Time frame: Baseline and Week 24
Percentage of Participants Who Experienced at Least One Adverse Event
Time frame: Up to 26 weeks
Number of Participants Who Discontinued Study Drug Due to an Adverse Event
Time frame: Up to 24 weeks
Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG)
Based on a cLDA model with terms for treatment, other prior AHA therapy status other than sitagliptin (yes/no), study drug regimen (just before meal/after meal), sitagliptin dosage (50 mg/100 mg), time and the interaction of time by treatment, time by other prior AHA therapy status, time by study drug regimen, time by sitagliptin dosage and study drug regimen by sitagliptin dosage, with a constraint that the mean baseline is the same for all treatment groups.
Time frame: Baseline and Week 24
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