Clinical Trials/NCT00482729

NCT00482729

Completed

Phase 3

A Randomized, Double-Blind, Active-Comparator Controlled, Clinical Trial to Study the Efficacy and Safety of MK0431A for the Treatment of Patients With Type 2 Diabetes Mellitus (T2DM)

Merck Sharp & Dohme LLC0 sites1,246 target enrollmentJune 19, 2007

ConditionsType 2 Diabetes Mellitus

Interventionssitagliptin phosphate (+) metformin hydrochloride metformin

Drugssitagliptin phosphate (+) metformin hydrochloride metformin

Overview

Phase: Phase 3
Intervention: sitagliptin phosphate (+) metformin hydrochloride
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Enrollment: 1246
Primary Endpoint: Change From Baseline in Hemoglobin A1c (A1C) at Week 18
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to investigate the efficacy and safety of an investigational treatment for type 2 diabetes mellitus.

Registry

clinicaltrials.gov

Start Date

June 19, 2007

End Date

April 27, 2009

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Merck Sharp & Dohme LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient has type 2 diabetes mellitus
•Patient is greater than or equal to 18 and less than or equal to 78 years of age on the day of signing the consent
•Patient has Hb1Ac greater than or equal to 7.5% and is appropriate for oral therapy
•Patient has not been on any antihyperglycemic agent (AHA) in the last 4 months
•Patient is a male, or a female who is unlikely to conceive

Exclusion Criteria

•Patient has type 1 diabetes mellitus or history of ketoacidosis

Arms & Interventions

1

Arm 1: drug

Intervention: sitagliptin phosphate (+) metformin hydrochloride

2

Arm 2: active comparator

Intervention: metformin

Outcomes

Primary Outcomes

Change From Baseline in Hemoglobin A1c (A1C) at Week 18

Time Frame: Baseline and Week 18

A1C is measured as percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.

Secondary Outcomes

Number of Patients With A1C < 7.0% at Week 18(Week 18)
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18(Baseline and Week 18)

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