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

NCT01545388 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 337

Last updated 2018-08-22

Study results available
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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.

Conditions

Interventions

DRUG

Sitagliptin

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

DRUG

Metformin

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

DRUG

Metformin

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

DRUG

Placebo

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01545388 on ClinicalTrials.gov