NCT00482729CompletedPhase 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)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 1,246
- Primary Endpoint
- Change From Baseline in Hemoglobin A1c (A1C) at Week 18
Study Overview
Brief Summary
The purpose of this study is to investigate the efficacy and safety of an investigational treatment for 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 78 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Experimental
Arm 1: drug
Intervention: sitagliptin phosphate (+) metformin hydrochloride (Drug)
2
Active Comparator
Arm 2: active comparator
Intervention: metformin (Drug)
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)
Investigators
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