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

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

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Type 2 Diabetes Mellitus
Intervention	Drug: Sitagliptin Drug: Metformin Drug: Metformin Drug: Placebo
Phase	Phase 3
Sponsor	Merck Sharp & Dohme Corp.
Responsible Party	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier	NCT01545388
First Received	March 1, 2012
Last Updated	February 10, 2014
Last verified	February 2014

Tracking Information[ + expand ][ + ]

First Received Date	March 1, 2012
Last Updated Date	February 10, 2014
Start Date	February 2012
Estimated Primary Completion Date	March 2013
Current Primary Outcome Measures	Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c) [Time Frame: Baseline and Week 24] [Designated as safety issue: No]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. Percentage of Participants Who Experienced at Least One Adverse Event [Time Frame: Up to 26 weeks] [Designated as safety issue: Yes] Number of Participants Who Discontinued Study Drug Due to an Adverse Event [Time Frame: Up to 24 weeks] [Designated as safety issue: Yes]
Current Secondary Outcome Measures	Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) [Time Frame: Baseline and Week 24] [Designated as safety issue: No]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.

Descriptive Information[ + expand ][ + ]

Brief Title	Metformin Add-on Regimen Comparison Study in Japanese Participants With Type 2 Diabetes Mellitus (MK-0431A-136)
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
Brief 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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 3
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Condition	Type 2 Diabetes Mellitus
Intervention	Drug: Sitagliptin Sitagliptin, orally, 50 or 100 mg tablet (continuation of the pre-study dose) Other Names: MK-0431/ONO-5435Drug: 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
Study Arm (s)	Experimental: 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. Experimental: 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. Placebo Comparator: 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.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	337
Estimated Completion Date	March 2013
Estimated Primary Completion Date	March 2013
Eligibility Criteria	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
Gender	Both
Ages	20 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Not Provided

Administrative Information[ + expand ][ + ]

NCT Number	NCT01545388
Other Study ID Numbers	0431A-136
Has Data Monitoring Committee	No
Information Provided By	Merck Sharp & Dohme Corp.
Study Sponsor	Merck Sharp & Dohme Corp.
Collaborators	Not Provided
Investigators	Not Provided
Verification Date	February 2014