NCT00289848
Completed
Phase 3
A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of MK0431 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
ConditionsType 2 Diabetes Mellitus
Interventionssitagliptin phosphate
Overview
- Phase
- Phase 3
- Intervention
- sitagliptin phosphate
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 530
- Primary Endpoint
- Change From Baseline in Hemoglobin A1c (HbA1c) at Week 18
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
This is a clinical study to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients have Type 2 Diabetes Mellitus and have laboratory results that are within the values established by the study such as an Hemoglobin A1c (HbA1c) \>=7.5% and \<=11% and a Fasting Plasma Glucose (FPG) \>=130 mg/dL and \<=280 mg/dL
- •Exclusion Criteria :
- •Patients have Type 1 Diabetes Mellitus or required insulin therapy within the past 12 months
Exclusion Criteria
- Not provided
Arms & Interventions
1
sitagliptin 100 mg
Intervention: sitagliptin phosphate
Outcomes
Primary Outcomes
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 18
Time Frame: Baseline and Week 18
A1C was measured as a percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.
Secondary Outcomes
- Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18(Baseline and Week 18)
- Change From Baseline in 2-hr Post-Meal Glucose (PMG) at Week 18(Baseline and Week 18)
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