Diabetes Mellitus, Type 2 Clinical Trial
— DIAGRAMOfficial title:
ADIponectin and ADMA Level in Type-2 Diabetes Patients After 12 Weeks of Treatment With GlimepiRide And Metformin Fixed Dose Combination (Amaryl-M)
Verified date | April 2012 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | Indonesia: Departement Kesehatan (Department of Health) |
Study type | Interventional |
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
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Indonesia | Sanofi-Aventis Administrative Office | Jakarta |
Lead Sponsor | Collaborator |
---|---|
Sanofi |
Indonesia,
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 |
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