Evaluation of Fixed Dose Combination of Glimepiride and Metformin in Chinese Type 2 Diabetes Patients Inadequately Controlled With Metformin

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.

Inclusion criteria:

• Chinese patients with type 2 diabetes mellitus, as defined by World Health Organization, diagnosed for at least 1 year at the time of screening visit and inadequately controlled with metformin
• Signed written informed consent

Exclusion criteria:

• Type 1 diabetes mellitus
• HbA1c < 7% or > 10%
• Fasting plasma glucose > 250 mg/dL (> 13.9 mmol/L)
• Age <18 years or Age ≥ 80 years
• Patients who have not been on stable daily dose of at least 1500 mg metformin within 3 months prior to screening
• Patients currently receiving or who have received anti-diabetic drugs other than metformin within 3 months prior to screening

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.