- ICH GCP
- US Clinical Trials Registry
- Clinical 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 (DIAGRAM)
ADIponectin and ADMA Level in Type-2 Diabetes Patients After 12 Weeks of Treatment With GlimepiRide And Metformin Fixed Dose Combination (Amaryl-M)
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:
- 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
- To evaluate the brachial-ankle pulse wave velocity (baPWV) change after 8 and 12 weeks of therapy with Amaryl-M
- To evaluate the efficacy of Amaryl-M in the improvement of patients glycemic level (Fasting blood glucose (FBG) and glycosylated hemoglobin (HbA1c))
- To evaluate the change of Tumor Necrosis Factor - Alfa (TNF-Alfa) after 12 weeks of therapy with Amaryl-M
- To evaluate the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) change after 12 weeks of therapy with Amaryl-M
- To evaluate the HOMA-β change after 12 weeks of therapy with Amaryl-M
- To evaluate the relationship between adiponectin and ADMA level with FBG or HbA1c level
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
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Jakarta, Indonesia
- Sanofi-Aventis Administrative Office
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Amaryl-M (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. |
Pharmaceutical form: film coated tablet Route of administration: oral Dose regimen: 1 tablet of 1/250 mg per day
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adiponectin and Asymmetric Dimethylarginine (ADMA) plasma level changes
Time Frame: from baseline to end of Clinical Trial (12 weeks)
|
from baseline to end of Clinical Trial (12 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in adiponectin and Asymmetric Dimethylarginine (ADMA) plasma levels
Time Frame: at week 8
|
at week 8
|
Pulse Wave Velocity (PWV) change
Time Frame: at week 8 and week 12
|
at week 8 and week 12
|
Change in Fasting Blood Glucose (FBG)
Time Frame: At week 2, 4, 8 and 12
|
At week 2, 4, 8 and 12
|
Change in glycosylated hemoglobin (HbA1c)
Time Frame: at week 12
|
at week 12
|
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) and Homeostatic Model Assessment (HOMA-β)
Time Frame: At week 12
|
At week 12
|
Change of Tumor Necrosis Factor- Alfa (TNF-Alfa)
Time Frame: At week 12
|
At week 12
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GLMET_L_04735
- U1111-1116-8173 (Other Identifier: UTN)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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