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
The clinical trial will consist of 2 weeks of selection followed by a 12 weeks (3 months) of treatment period.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Pharmaceutical form: film coated tablet Route of administration: oral Dose regimen: 1 tablet of 1/250 mg per day
Sanofi-Aventis Administrative Office
Jakarta, Indonesia
Adiponectin and Asymmetric Dimethylarginine (ADMA) plasma level changes
Time frame: from baseline to end of Clinical Trial (12 weeks)
Change in adiponectin and Asymmetric Dimethylarginine (ADMA) plasma levels
Time frame: at week 8
Pulse Wave Velocity (PWV) change
Time frame: at week 8 and week 12
Change in Fasting Blood Glucose (FBG)
Time frame: At week 2, 4, 8 and 12
Change in glycosylated hemoglobin (HbA1c)
Time frame: at week 12
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) and Homeostatic Model Assessment (HOMA-β)
Time frame: At week 12
Change of Tumor Necrosis Factor- Alfa (TNF-Alfa)
Time frame: At week 12
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