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

• Status: Completed
• Trial end date: 2012-12-24
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Metformin; Sitagliptin Phosphate

Criteria

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