Safety and Efficacy of Co-Administration of Sitagliptin and Metformin in China (MK-0431-121)

A Phase III, Multicenter, Double-Blind, Randomized, Placebo-Controlled Clinical Trial in China to Study the Safety and Efficacy of Co-administration of Sitagliptin and Metformin in Patients With Type 2 Diabetes Mellitus

This study will assess the efficacy and safety of initial treatment with sitagliptin and metformin in patients with type 2 diabetes mellitus in China. The primary hypothesis is that after 24 weeks, initial co-administration treatment with sitagliptin and metformin provided greater reduction in hemoglobin A1C (A1C) compared to initial treatment with sitagliptin alone and with metformin alone.

Inclusion Criteria:

• has type 2 diabetes mellitus
• is male, a female who cannot have children, or a female who agrees to use birth control during the study
• is not on an antihyperglycemic agent (AHA) (hemoglobin A1c [A1C] 7.5-11.0%) or on oral single AHA (A1C 7.0-10.5%) or low-dose AHA combination therapy (A1C 7.0-10.0%)

Exclusion Criteria:

• Patient has type 1 diabetes mellitus or ketoacidosis
• Patient is taking a dipeptidyl peptidase-4 (DPP-4) inhibitor (such as sitagliptin)
• Patient is on a weight loss program not in the maintenance phase or on a weight loss medication
• Patient has a history of liver disease, heart failure, heart disease, stroke, high blood pressure, blood disorders, or cancer
• Patient is HIV positive
• Patient is pregnant