An Investigational Drug Study in Patients With Type 2 Diabetes Mellitus (MK0431-023)
Phase 3
Completed
- Conditions
- Diabetes Mellitus, Type 2
- Registration Number
- NCT00094757
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The purpose of this study is to determine the safety and effectiveness of an investigational drug in patients with Type 2 Diabetes Mellitus.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 521
Inclusion Criteria
- Patients at least 18 years of age and not older than 75 who have a specific type of diabetes called Type 2 Diabetes Mellitus
Exclusion Criteria
- Younger than 18 years of age or older than 75
- Any condition, which in the opinion of the investigator, may not be in the patient's best interest to participate
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change From Baseline in A1C at Week 18 Weeks 0-18 Hemoglobin A1C (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 Change From Baseline in FPG at Week 18 Weeks 0-18 The change from baseline reflects the Week 18 Fasting Plasma Glucose (FPG) minus the Week 0 FPG.
Change From Baseline in FPG at Week 54 Weeks 0-54 The change from baseline reflects the Week 54 FPG minus the Week 0 FPG.
Change From Baseline in A1C at Week 54 Weeks 0-54 A1C is measured as percent. Thus this change from baseline reflects the Week 54 A1C percent minus the Week 0 A1C percent.