drugset / Trial / NCT01699932

Efficacy and Safety of the Fixed Dose Combination of Glimepiride+Metformin in Type 2 Diabetic Patients Inadequately Controlled

NCT01699932

Phase 3 Completed 167 enrolled Sanofi
Non-randomizedSingle-groupOpen-labelTreatment

Summary

Primary Objective: -To demonstrate the efficacy of a fixed combination of glimepiride + metformin in terms of HbA1c reduction, during 24-week treatment period in patients with inadequately controlled type 2 diabetes mellitus. Secondary Objective: To assess the effects of the fixed combination of glimepiride and metformin at week 24 on: * Percentage of patients reaching HbA1c \<7% * Percentage of patients reaching HbA1c \<6.5%. * Fasting Plasma Glucose (FPG) * Safety and tolerability

Timeline

Start
2012-09
Primary completion
2014-04
Completion
2014-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Glimepiride Small molecule 8 mg Oral
Subject Metformin Small molecule 2000 mg Oral