Overview

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

Status:
Completed
Trial end date:
2013-02-01
Target enrollment:
0
Participant gender:
All
Summary
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).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sanofi
Treatments:
Glimepiride
Metformin
Criteria
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.