Overview

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

Status:
Completed
Trial end date:
2014-01-01
Target enrollment:
Participant gender:
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
Phase:
Phase 3
Details
Lead Sponsor:
Sanofi
Treatments:
Glimepiride
Metformin