MK0431A vs. Pioglitazone in Patients With Type 2 Diabetes Mellitus (0431A-066)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes Mellitus
Intervention: sitagliptin phosphate (+) metformin hydrochloride (Drug); Comparator: pioglitazone (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp. Official(s) and/or principal investigator(s): Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.
Summary
A study to evaluate the efficacy and safety of MK0431A in comparison to a commonly used
medication in patients with type 2 diabetes
Clinical Details
Official title: A Phase III Randomized, Active-Comparator (Pioglitazone) Controlled Clinical Trial to Study the Efficacy and Safety of the MK0431A (A Fixed-Dose Combination Tablet of Sitagliptin and Metformin) in Patients With Type 2 Diabetes Mellitus
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Change From Baseline in A1C at Week 32
Secondary outcome: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 1Change From Baseline in 2-hour Post-Meal Glucose (PMG) at Week 32 Change From Baseline in FPG at Week 32 Percent of Participants With A1C <7.0% at Week 32
Eligibility
Minimum age: 18 Years.
Maximum age: 78 Years.
Gender(s): Both.
Criteria:
General Inclusion Criteria:
- Patient has type 2 diabetes mellitus
- Patient is inadequately controlled and not on treatment with insulin or oral
antihyperglycemic therapy
General Exclusion Criteria:
- Patient has a history of type 1 diabetes mellitus or history of ketoacidosis
- Patient was on antihyperglycemic agent therapy (oral or insulin) within the prior 12
weeks
- Patient was on >4 weeks (cumulatively) of antihyperglycemic therapy (oral or insulin)
over the prior 3 years
Locations and Contacts
Additional Information
Starting date: January 2008
Last updated: February 20, 2015
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