drugset / Trial / NCT01204580

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

NCT01204580

Phase 4 Completed 40 enrolled Sanofi
Non-randomizedSingle-groupOpen-labelTreatment

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

Timeline

Start
2010-12
Primary completion
2012-03
Completion
2012-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Glimepiride Small molecule 1 mg Oral
Subject Metformin Small molecule 250 mg Oral