Diabetes Mellitus, Type 2
Conditions
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.
Interventions
Pharmaceutical form: film coated tablet Route of administration: oral Dose regimen: 1 tablet of 1/250 mg per day
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adiponectin and Asymmetric Dimethylarginine (ADMA) plasma level changes | from baseline to end of Clinical Trial (12 weeks) |
Secondary
| Measure | Time frame |
|---|---|
| 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 adiponectin and Asymmetric Dimethylarginine (ADMA) plasma levels | at week 8 |
| 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 |
| Change in glycosylated hemoglobin (HbA1c) | at week 12 |
Countries
Indonesia
Outcome results
None listed