ADIponectin and Asymmetric Dimethylarginine (ADMA) Level in Type-2 Diabetes Patients After 12 Weeks of Treatment With GlimepiRide And Metformin Fixed Dose Combination

Study Overview
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Brief Summary
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Primary Objective: To evaluate the change in plasma levels of adiponectin and Asymmetric Dimethylarginine (ADMA) in type 2 diabetes patients after 12 weeks of treatment with Amaryl-M Secondary Objectives: To assess the role of Amaryl-M in the change of plasma levels of adiponectin and ADMA in type 2 diabetes patients after 8 weeks of therapy To evaluate the brachial-ankle pulse wave velocity (baPWV) change after 8 and 12 weeks of therapy with Amaryl-M To evaluate the efficacy of Amaryl-M in the improvement of patients glycemic level (Fasting blood glucose (FBG) and glycosylated hemoglobin (HbA1c)) To evaluate the change of Tumor Necrosis Factor - Alfa (TNF-Alfa) after 12 weeks of therapy with Amaryl-M To evaluate the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) change after 12 weeks of therapy with Amaryl-M To evaluate the HOMA-β change after 12 weeks of therapy with Amaryl-M To evaluate the relationship between adiponectin and ADMA level with FBG or HbA1c level

Detailed Description
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The clinical trial will consist of 2 weeks of selection followed by a 12 weeks (3 months) of treatment period.

Official Title
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ADIponectin and ADMA Level in Type-2 Diabetes Patients After 12 Weeks of Treatment With GlimepiRide And Metformin Fixed Dose Combination (Amaryl-M)

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: GLIMEPIRIDE + METFORMIN


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Type 2 diabetes mellitus patients Patients with HbA1c >or= 7.0% and < 10.0% Patients not currently treated with any oral antidiabetic drugs (OADs) Exclusion criteria: Participation in other investigational Clinical Trial Current temporary insulin treatment: gestational diabetes, pancreas cancer, surgery etc. Women who are pregnant and lactating Type 1 diabetes mellitus patients Treatment with antihypertensive Angiotensin-Converting Enzyme (ACE)-Inhibitors and/or Angiotensin II Receptor Blocker (ARB) or has just stopped treatment for less than two months Treatment with lipid lowering agent statins or has just stopped treatment for less than two months Known hypersensitive to any of the excipients of Amaryl-M, sulphonylureas, sulfonamides or biguanide Patients with active smoking or history of smoking cessation less than 2 months Patients with history of severe hepatic dysfunction Patients with serum creatinine >or= 1.5 mg/dL (male) and >or= 1.4 mg/dL (female) Patients with congestive heart failure requiring pharmacologic treatment Treatment with antifungal agent especially Miconazole 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: 40 Years
Maximum Age: 60 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amaryl-M (Glimepiride + Metformin)<br>Glimepiride 1 mg and metformin 250 mg are the active ingredients of Amaryl-M 1/250 mg film coated tablets. Starting dosage is 1 tablet per day, then dosage titration will be based on the result of patient FBG test. | Drug: GLIMEPIRIDE + METFORMIN<br>* Pharmaceutical form: film coated tablet Route of administration: oral Dose regimen: 1 tablet of 1/250 mg per day<br>* Other names: Amaryl-M;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adiponectin and Asymmetric Dimethylarginine (ADMA) plasma level changes |  | from baseline to end of Clinical Trial (12 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in adiponectin and Asymmetric Dimethylarginine (ADMA) plasma levels |  | at week 8 | 
| Pulse Wave Velocity (PWV) change |  | at week 8 and week 12 | 
| Change in Fasting Blood Glucose (FBG) |  | At week 2, 4, 8 and 12 | 
| Change in glycosylated hemoglobin (HbA1c) |  | at week 12 | 
| Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) and Homeostatic Model Assessment (HOMA-β) |  | At week 12 | 
| Change of Tumor Necrosis Factor- Alfa (TNF-Alfa) |  | At week 12 |