Status:
COMPLETED
ADIponectin and Asymmetric Dimethylarginine (ADMA) Level in Type-2 Diabetes Patients After 12 Weeks of Treatment With GlimepiRide And Metformin Fixed Dose Combination
Lead Sponsor:
Sanofi
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
40-60 years
Phase:
PHASE4
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 Objec...
Detailed Description
The clinical trial will consist of 2 weeks of selection followed by a 12 weeks (3 months) of treatment period.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01204580
Start Date
December 1 2010
End Date
March 1 2012
Last Update
April 3 2012
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Jakarta, Indonesia