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

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

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

The study duration for each patient is approximately 27 weeks with 3 periods: 2-week screening period followed by 24-week treatment period and 3 days follow-up period with a last call phone visit.

Inclusion criteria:

• Patients with type 2 diabetes mellitus inadequately controlled despite a treatment with sulfonylurea (SU) alone or metformin alone or a free combination of SU and metformin prior to the study entry.
• Signed informed consent, obtained prior any study procedure

Exclusion criteria:

• Age < legal age of adulthood
• HbA1c < 7% or ≥ 11%
• BMI > 35 kg/m2
• Treatment with a stable dose of maximally tolerated SU alone or metformin alone or the free combination of SU and metformin for less than 12 weeks prior to the screening visit.
• Patients who received any anti-diabetic drug other than SU or metformin within 12 weeks prior to the screening visit.
• Diabetes other than type 2 diabetes (e.g. type 1 diabetes, diabetes secondary to pancreatic disorders, drug or chemical agent intake…)

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