Type 2 Diabetes Mellitus Clinical Trial
Official title:
A Multicenter, Randomized, Open-label, 2-arm Parallel Group, 20-week Study Comparing the Efficacy and Safety of Fixed-dose Combination of 1 mg Glimepiride and 250 mg Metformin (AMARYL M 1/250 mg) Versus Glimepiride (AMARYL®) in Chinese Type 2 Diabetes Patients Inadequately Controlled With Metformin.
Primary Objective:
- To evaluate the efficacy of fixed dose combination of glimepiride and metformin (AMARYL
M 1/250mg) in comparison with glimepiride (AMARYL) alone in terms of glycemic control
as reflected by HbA1c during a 20-week treatment period in patients with type 2
diabetes mellitus (T2DM) inadequately controlled with metformin.
Secondary Objectives:
- To evaluate the percentage of patients reaching HbA1c < 7% or HbA1c ≤ 6.5% of fixed
dose combination of 1 mg glimepiride and 250 mg metformin (AMARYL M 1/250mg) in
comparison with glimepiride (AMARYL) alone at week 20.
- To evaluate the effect on Fasting Plasma Glucose of fixed dose combination of
glimepiride and metformin (AMARYL M 1/250mg) in comparison with glimepiride (AMARYL)
alone at week 20.
- To assess the safety and tolerability of fixed dose combination of glimepiride and
metformin (AMARYL M 1/250mg).
The study consists of an up to 2-week screening period, a 20-week treatment period, and a 3-day safety follow-up period. Total study duration is up to 23 weeks. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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