Comparative Study of HOE490 O (Glimepiride and Metformin) Compared With Placebo on Top of Glimepiride

Study Overview
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Brief Summary
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Primary objective of this study is to confirm the efficacy of HOE490 O (glimepiride/metformin) compared with placebo on top of glimepiride in HbA1c change. Secondary objectives of this study is to evaluate the safety of HOE490 O (glimepiride/metformin) compared with placebo on top of glimepiride as well as other efficacy parameters

Detailed Description
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Patients treated with 2-6mg/day of glimepiride will be recruited. The study period consists of screening phase of 6 weeks and double-blinded phase of 24 weeks.

Official Title
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Double-blinded Comparative Study to Investigate the Efficacy and Safety of HOE490 O (Glimepiride and Metformin) Compared With Placebo on Top of Glimepiride in Patients With T2DM Inadequately Treated With Constant Dose of Glimepiride

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Metformin
* Drug: placebo
* Drug: Glimepiride (HOE490)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 Diabetes Mellitus patients treated with constant dose of glimepiride on top of diet and exercise Patients who gave informed consent to participate in the study Exclusion Criteria: Patients with HbA1c of < 7.0 % and > 11.0 % Patients with any following laboratory test abnormality : ALT and/or AST: > 3 X ULN Neutrophils: < 1,000/mm3 and/or platelets < 100,000/mm3 Hemoglobin: <11 g/dL Creatinine: >= 1.3 mg/dL in case of male or >= 1.0 mg/dL in case of female 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: 20 Years
Maximum Age: 74 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Metformin on top of glimepiride Twice a day with 2-6 mg of daily dose for glimepiride and 500-750mg of daily dose for metformin for 24 weeks | Drug: Metformin<br>* oral administration<br>Drug: Glimepiride (HOE490)<br>* oral administration<br>|
| Placebo Comparator: 2<br>Placebo on top of glimepiride Twice a day with 2-6 mg of daily dose for glimepiride and 2-3 tablets of placebo for 24 weeks | Drug: placebo<br>* oral administration<br>Drug: Glimepiride (HOE490)<br>* oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in HbA1c from baseline |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the ratio patients with < 7.0% of HbA1c |  | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glimepiride, Metformin, Combination Drug Therapy