A Multinational, Open Label, Non Comparative, 24-week Study to Evaluate the Blood Glucose Lowering Efficacy and Safety of a Fixed Dose Combination of Glimepiride and Metformin in Patients With Inadequately Controlled Type 2 Diabetes (LEGEND)

NCT01699932 Phase 3 COMPLETED

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

Details

Lead sponsor	Sanofi
Phase	Phase 3
Status	COMPLETED
Enrolment	167
Start date	2012-09
Completion	2014-04

Conditions

• Type 2 Diabetes Mellitus

Interventions

• Glimepiride+metformin (Amaryl M®) - HOE4900

Primary outcomes

• Change in HbA1c — from baseline to week 24

Countries

Lebanon, Russia, Ukraine