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

Study Overview
=================
Brief 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).

Detailed Description
-----------------
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.

Official Title
-----------------
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.

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Glimepiride and Metformin hydrochloride combination (HOE490)
* Drug: Glimepiride (HOE490)


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AMARYL M (Glimepiride and Metformin hydrochloride combination)<br>AMARYL M at a dosage regimen from 1 tablet to 6 tablets, once during a meal or twice during a meal | Drug: Glimepiride and Metformin hydrochloride combination (HOE490)<br>* Pharmaceutical form:tablet Route of administration: oral<br>|
| Active Comparator: AMARYL (Glimepiride)<br>AMARYL at a dosage regimen from 1 mg to 6 mg, once during a meal or twice during a meal | Drug: Glimepiride (HOE490)<br>* Pharmaceutical form:tablet Route of administration: oral<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change in HbA1c |  | 20 weeks, from baseline to week 20 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients reaching HbA1c < 7% or HbA1c ≤ 6.5%, respectively |  | 20 weeks, at week 20 | 
| Absolute change in Fasting Plasma Glucose |  | 20 weeks, from baseline to week 20 | 
| Number of patients reporting adverse events |  | 20 weeks, from baseline to week 20 | 
| Number of patients reporting serious adverse events |  | 20 weeks, from baseline to week 20 | 
| Hypoglycemia |  | 20 weeks, from baseline to week 20 | 
| Vital signs |  | 20 weeks, from baseline to week 20 | 
| Hematology, Serum chemistry and lipids |  | 20 weeks, from baseline to week 20 |