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

Study Overview
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Brief Summary
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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

Detailed Description
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The study duration for each patient is approximately 27 weeks with 3 periods: 2-week screening period followed by 24-week treatment period where patient is assigned to one of the three arms according to randomization, and 3 days follow-up period with a last call phone visit.

Official Title
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A Multinational, Open Label, Randomized, Active-controlled, 3-arm Parallel Group, 24-week Study Comparing the Combination of Glimepiride and Metformin Versus Glimepiride and Metformin Alone in Patients With Type 2 Diabetes

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: GLIMEPIRIDE
* Drug: METFORMIN


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 78 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ARM 1: glimepiride alone<br>24-week treatment period: After randomization, starting dose will be of 2 mg /day or 1 mg/day of glimepiride if Fasting Plasma Glucose (FPG) at baseline < 180 mg/dL (10 mmol/L) taken once in the morning before breakfast. The treatment's dose will be increased every 2 weeks up to the maximum tolerated dose of 4 mg, and adjusted throughout the 24-week treatment period according to fasting Self Monitored Plasma Glucose (SMPG) values in the objective to obtain fasting SMPG values ≤ 130mg/dL (7.2mmol/L) and > 70 mg/dL (3.9mmol/L) without symptomatic hypoglycemia. | Drug: GLIMEPIRIDE<br>* Pharmaceutical form: oral Route of administration: oral<br>* Other names: HOE490;|
| Experimental: ARM 2: metformin alone<br>24-week treatment period: After randomization, starting dose will be of 500 mg of metformin twice a day during or after meals. The treatment's dose will be increased every 2 weeks up to the maximum tolerated dose of 2000 mg, and adjusted throughout the 24-week treatment period according to fasting SMPG values in the objective to obtain fasting SMPG values ≤ 130mg/dL (7.2mmol/L) and > 70 mg/dL (3.9mmol/L) without symptomatic hypoglycemia. | Drug: METFORMIN<br>* Pharmaceutical form: oral Route of administration: oral<br>|
| Experimental: ARM3: Glimepiride/metformin free combination<br>24-week treatment period: After randomization, starting dose will be of 2 mg /day or 1 mg/day of glimepiride if FPG at baseline < 180 mg/dL (10 mmol/L) taken once in the morning and 500 mg of metformin twice a day taken during or after meals. The treatment's dose will be increased every 2 weeks up to the maximum tolerated dose of 4 mg of glimepiride and 2000 mg of metformin, and adjusted throughout the 24-week treatment period according to fasting SMPG values in the objective to obtain values ≤. | Drug: GLIMEPIRIDE<br>* Pharmaceutical form: oral Route of administration: oral<br>* Other names: HOE490;Drug: METFORMIN<br>* Pharmaceutical form: oral Route of administration: oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c |  | from baseline to week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with HbA1c < 7% |  | at week 24 | 
| Percentage of patients with HbA1c < 6.5 % |  | at week 24 | 
| Change in Fasting Plasma Glucose (FPG) |  | from baseline week 24 | 
| Number of patients reporting adverse events |  | overt the 24-weeks treatment period | 
| Frequence and incidence of hypoglycemia |  | over the 24-weeks treatment period |