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

Overview

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: 1. 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 2. To evaluate the brachial-ankle pulse wave velocity (baPWV) change after 8 and 12 weeks of therapy with Amaryl-M 3. To evaluate the efficacy of Amaryl-M in the improvement of patients glycemic level (Fasting blood glucose (FBG) and glycosylated hemoglobin (HbA1c)) 4. To evaluate the change of Tumor Necrosis Factor – Alfa (TNF-Alfa) after 12 weeks of therapy with Amaryl-M 5. To evaluate the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) change after 12 weeks of therapy with Amaryl-M 6. To evaluate the HOMA-β change after 12 weeks of therapy with Amaryl-M 7. To evaluate the relationship between adiponectin and ADMA level with FBG or HbA1c level

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2012

Detailed Description

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

Interventions

  • Drug: GLIMEPIRIDE + METFORMIN
    • Pharmaceutical form: film coated tablet Route of administration: oral Dose regimen: 1 tablet of 1/250 mg per day

Arms, Groups and Cohorts

  • Experimental: Amaryl-M (Glimepiride + Metformin)
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Adiponectin and Asymmetric Dimethylarginine (ADMA) plasma level changes
    • Time Frame: from baseline to end of Clinical Trial (12 weeks)

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sanofi
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Clinical Sciences & Operations, Study Director, Sanofi

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