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

Diabetes Mellitus, Type 2 Clinical Trial

— DIAGRAM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01204580
• Other study ID #: GLMET_L_04735
• Secondary ID: U1111-1116-8173
• Status: Completed
• Phase: Phase 4
• First received: September 16, 2010
• Last updated: April 2, 2012
• Start date: December 2010
• Est. completion date: March 2012

Study information

• Verified date: April 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Indonesia: Departement Kesehatan (Department of Health)
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

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

Locations

Country	Name	City	State
Indonesia	Sanofi-Aventis Administrative Office	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adiponectin and Asymmetric Dimethylarginine (ADMA) plasma level changes		from baseline to end of Clinical Trial (12 weeks)	No
Secondary	Change in adiponectin and Asymmetric Dimethylarginine (ADMA) plasma levels		at week 8	No
Secondary	Pulse Wave Velocity (PWV) change		at week 8 and week 12	No
Secondary	Change in Fasting Blood Glucose (FBG)		At week 2, 4, 8 and 12	No
Secondary	Change in glycosylated hemoglobin (HbA1c)		at week 12	No
Secondary	Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) and Homeostatic Model Assessment (HOMA-ß)		At week 12	No
Secondary	Change of Tumor Necrosis Factor- Alfa (TNF-Alfa)		At week 12	No