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

Sanofi

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: GLIMEPIRIDE + METFORMIN

Study type: Interventional

Funder types: Industry

Identifiers

NCT01204580

GLMET_L_04735

U1111-1116-8173 (Other Identifier)

Details and patient eligibility

About

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 description

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

Enrollment: 40 patients

Sex: All

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Amaryl-M (Glimepiride + Metformin)

Experimental group

Description:

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.

Treatment:

Drug: GLIMEPIRIDE + METFORMIN