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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

337 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-23

Study Completion Date

2013-03-12

Brief Summary

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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.

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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Metformin 500 mg q.d.

Participants will receive sitagliptin daily (continuing their pre-study dose), 2 metformin 250 mg tablets in the morning and 1 matching placebo tablet in the evening.

Group Type EXPERIMENTAL

Sitagliptin

Intervention Type DRUG

Sitagliptin, orally, 50 or 100 mg tablet (continuation of the pre-study dose)

Metformin

Intervention Type DRUG

Metformin, orally, 500 mg daily (single dose; two 250 mg tablets) for 24 weeks

Placebo

Intervention Type DRUG

Placebo to match metformin 250 mg tablets, orally, for 24 weeks

Metformin 250 mg b.i.d.

Participants will receive sitagliptin daily (continuing their pre-study dose), 1 metformin 250 mg tablet and 1 matching placebo tablet in the morning and 1 metformin 250 mg tablet in the evening.

Group Type EXPERIMENTAL

Sitagliptin

Intervention Type DRUG

Sitagliptin, orally, 50 or 100 mg tablet (continuation of the pre-study dose)

Metformin

Intervention Type DRUG

Metformin, orally, 500 mg daily (divided dose; 250 mg tablet b.i.d.) for 24 weeks

Placebo

Intervention Type DRUG

Placebo to match metformin 250 mg tablets, orally, for 24 weeks

Placebo

Participants will receive sitagliptin daily (continuing their pre-study dose), 2 matching placebo tablets in the morning and 1 matching placebo tablet in the evening.

Group Type PLACEBO_COMPARATOR

Sitagliptin

Intervention Type DRUG

Sitagliptin, orally, 50 or 100 mg tablet (continuation of the pre-study dose)

Placebo

Intervention Type DRUG

Placebo to match metformin 250 mg tablets, orally, for 24 weeks

Interventions

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Sitagliptin

Sitagliptin, orally, 50 or 100 mg tablet (continuation of the pre-study dose)

Intervention Type DRUG

Metformin

Metformin, orally, 500 mg daily (single dose; two 250 mg tablets) for 24 weeks

Intervention Type DRUG

Metformin

Metformin, orally, 500 mg daily (divided dose; 250 mg tablet b.i.d.) for 24 weeks

Intervention Type DRUG

Placebo

Placebo to match metformin 250 mg tablets, orally, for 24 weeks

Intervention Type DRUG

Other Intervention Names

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MK-0431/ONO-5435

Eligibility Criteria

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Inclusion Criteria

* Type 2 Diabetes Mellitus (T2DM)
* Currently being treated with diet/exercise and on stable dose of sitagliptin for ≥ 4 weeks, on any additional oral hypoglycemic agent (AHA) in the prior 8 weeks, and HbA1c ≥ 6.0% and ≤ 9.0%; or
* Currently being treated with diet/exercise and on stable dose of sitagliptin for ≥ 10 weeks, not on any additional oral AHA in the prior 8 weeks, and HbA1c ≥ 6.5% and \< 10.0%