At a glance
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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
In Brief
A Phase 3 clinical trial evaluating Sitagliptin 50 mg, Metformin 500 mg, and 3 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 744 participants.
Detailed 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.
Study Details
Timeline
Interventions
Sitagliptin 50 mg tablet twice a day, prior to the morning and evening meal, for 24 weeks.
Metformin 500 mg tablet twice daily, prior to the morning and evening meal, for 24 weeks.
Sitagliptin 100 mg once daily for 24 weeks.
Matching placebo tablets to sitagliptin or metformin for 24 weeks.
Metformin 850 mg tablet twice daily, prior to the morning and evening meal, for 24 weeks.