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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 1

Change 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

Page last updated: August 23, 2015

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