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

NCT ID: NCT01204580

Last Updated: 2012-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2012-03-31

Brief 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

Detailed Description

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

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

GLIMEPIRIDE + METFORMIN

Intervention Type: DRUG

Pharmaceutical form: film coated tablet Route of administration: oral Dose regimen: 1 tablet of 1/250 mg per day

Interventions

GLIMEPIRIDE + METFORMIN

Pharmaceutical form: film coated tablet Route of administration: oral Dose regimen: 1 tablet of 1/250 mg per day

Intervention Type: DRUG

Other Intervention Names

Amaryl-M

Eligibility 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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis Administrative Office

Jakarta, , Indonesia

Countries

Indonesia

Other Identifiers

U1111-1116-8173

Identifier Type: OTHER

Identifier Source: secondary_id

GLMET_L_04735

Identifier Type: -

Identifier Source: org_study_id