drugset / Trial / NCT01076088

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

NCT01076088

Phase 3 Completed 744 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2010-11-15
Primary completion
2012-12-24
Completion
2012-12-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Metformin Small molecule 500 mg
Subject Metformin Small molecule 850 mg
Subject Sitagliptin Small molecule 50 mg
Subject Sitagliptin Small molecule 100 mg