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

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Glimepiride; Metformin; N,N-dimethylarginine

Criteria

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.