NCT00094757CompletedPhase 3
A Multicenter, Randomized, Double-Blind Study of MK0431 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 521
- Primary Endpoint
- Change From Baseline in A1C at Week 18
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Sitagliptin 100 mg
Experimental
Sitagliptin 100 mg
Intervention: Comparator: sitagliptin 100 mg (Drug)
Sitagliptin 200 mg
Experimental
Sitagliptin 200 mg
Intervention: Comparator: sitagliptin 200 mg (Drug)
Placebo/Pioglitazone
Placebo Comparator
Placebo/Pioglitazone
Intervention: Comparator: placebo (Drug)
Placebo/Pioglitazone
Placebo Comparator
Placebo/Pioglitazone
Intervention: Comparator: pioglitazone (Drug)
Outcomes
Primary Outcomes
Change From Baseline in A1C at Week 18
Time Frame: 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 Outcomes
- Change From Baseline in FPG at Week 18(Weeks 0-18)
- Change From Baseline in FPG at Week 54(Weeks 0-54)
- Change From Baseline in A1C at Week 54(Weeks 0-54)
Investigators
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