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

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Glimepiride; Metformin

Criteria

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.