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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01545388
• Other study ID #: 0431A-136
• Secondary ID: ONO-5435A
• Status: Completed
• Phase: Phase 3
• Start date: February 23, 2012
• Est. completion date: March 12, 2013

Study information

• Verified date: July 2018
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 337
• Est. completion date: March 12, 2013
• Est. primary completion date: March 12, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 74 Years

Eligibility

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%

Exclusion Criteria:

• Type 1 diabetes mellitus,

• Secondary diabetes mellitus, or

• Gestational diabetes mellitus

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Sitagliptin
Sitagliptin, orally, 50 or 100 mg tablet (continuation of the pre-study dose)
• Metformin
Metformin, orally, 500 mg daily (single dose; two 250 mg tablets) for 24 weeks
• Metformin
Metformin, orally, 500 mg daily (divided dose; 250 mg tablet b.i.d.) for 24 weeks
• Placebo
Placebo to match metformin 250 mg tablets, orally, for 24 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and Week 24
Primary	Percentage of Participants Who Experienced at Least One Adverse Event		Up to 26 weeks
Primary	Number of Participants Who Discontinued Study Drug Due to an Adverse Event		Up to 24 weeks
Secondary	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.	Baseline and Week 24