drugset / Trial / NCT01459809

Efficacy and Safety Comparison of Metformin/Glimepiride Combination Versus Each Compound Alone in New Diagnosed Type 2 Diabetes Patients

NCT01459809

Phase 3 Completed 538 enrolled Sanofi
RandomizedParallel-groupOpen-labelTreatment

Summary

Primary Objective: \- To demonstrate the superiority of glimepiride and metformin free combination in comparison to glimepiride or metformin alone in terms of Hb1Ac reduction during a 24-week treatment period in patients with type 2 diabetes mellitus. Secondary Objectives: \- To assess the effects of the free combination of glimepiride and metformin in comparison to glimepiride or metformin alone on: * Percentage of patients reaching HbA1c \< 7% * Percentage of patients reaching HbA1c \< 6.5% * Fasting Plasma Glucose (FPG) * Safety and tolerability

Timeline

Start
2012-02
Primary completion
2014-01
Completion
2014-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Glimepiride Small molecule 4 mg Oral
Subject Metformin Small molecule 2000 mg Oral