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ADIponectin and ADMA Level in Type-2 Diabetes Patients After 12 Weeks of Treatment With GlimepiRide And Metformin Fixed Dose Combination (Amaryl-M)


Phase 4
40 Years
60 Years
Not Enrolling
Both
Diabetes Mellitus, Type 2

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Trial Information

ADIponectin and ADMA Level in Type-2 Diabetes Patients After 12 Weeks of Treatment With GlimepiRide And Metformin Fixed Dose Combination (Amaryl-M)


The clinical trial will consist of 2 weeks of selection followed by a 12 weeks (3 months) of
treatment period.

Inclusion Criteria


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Adiponectin and Asymmetric Dimethylarginine (ADMA) plasma level changes

Outcome Time Frame:

from baseline to end of Clinical Trial (12 weeks)

Safety Issue:

No

Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

Indonesia: Departement Kesehatan (Department of Health)

Study ID:

GLMET_L_04735

NCT ID:

NCT01204580

Start Date:

December 2010

Completion Date:

March 2012

Related Keywords:

  • Diabetes Mellitus, Type 2
  • Diabetes Mellitus
  • Diabetes Mellitus, Type 2

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