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

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: GLIMEPIRIDE + METFORMIN

• Registration Number: NCT01204580
• Lead Sponsor: Sanofi

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.

Study Timeline

• Study First Submitted: 2010-09-16
• Study First Submitted QC: 2010-09-16
• Study First Posted: 2010-09-17
• Study Start: 2010-12
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-02
• Last Update Posted: 2012-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Amaryl-M (Glimepiride + Metformin)	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇮🇩 Jakarta, Indonesia