MK0431A Comparative Study in Patients With Type 2 Diabetes (0431A-079)(COMPLETED)
Phase 3
Completed
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Registration Number
- NCT00482729
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The purpose of this study is to investigate the efficacy and safety of an investigational treatment for type 2 diabetes mellitus.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1246
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 sitagliptin phosphate (+) metformin hydrochloride Arm 1: drug 2 metformin Arm 2: active comparator
- Primary Outcome Measures
Name Time Method Change From Baseline in Hemoglobin A1c (A1C) at Week 18 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 Outcome Measures
Name Time Method 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 FPG is measured as mg/dL. Thus, this change from baseline reflects the Week 18 FPG mg/dL minus the Week 0 FPG mg/dL.