Efficacy and Safety Comparison of Metformin/Glimepiride Combination Versus Each Compound Alone in New Diagnosed Type 2 Diabetes Patients

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

Summary

Primary Objective:

• To demonstrate the superiority of glimepiride and metformin free combination in comparison to glimepiride or metformin alone in terms of Hb1Ac reduction during a 24-week treatment period in patients with type 2 diabetes mellitus.

Secondary Objectives:

• To assess the effects of the free combination of glimepiride and metformin in comparison to glimepiride or metformin alone 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, as defined by the World Health Organization (WHO), diagnosed within one year prior to the screening visit

• Signed informed consent, obtained prior to any study procedure

Exclusion criteria

• Age < 18 and => 78 years old

• HbA1c < 7.6% or > 9%

• BMI > 35 kg/m2

• Diabetes other than type 2 diabetes (e.g.: type 1 diabetes, diabetes secondary to pancreatic disorders, drug or chemical agent intake...)

• Subjects currently receiving or who have received any hypoglycemic agent within 3 months before screening visit

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