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Irbesartan in Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborators:
Bristol-Myers Squibb
Sanofi-Synthelabo
Information provided by:
Steno Diabetes Center
ClinicalTrials.gov Identifier:
NCT00317915
First received: April 24, 2006
Last updated: NA
Last verified: April 2006
History: No changes posted

April 24, 2006
April 24, 2006
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Development of overt nephropathy
Same as current
No Changes Posted
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Irbesartan in Type 2 Diabetes
The Irbesartan in Patients With Type 2 Diabetes and Microalbuminuria (IRMA 2)

The aim of this multicenter, doubleblind, randomized study was to investigate the renoprotective effect of irbesartan treatment in patients with type 2 diabetes and microalbuminuria (a precursor of diabetic kidney disease). 590 patients were randomized to a median 24 months of treatment with 300 mg irbesartan once daily, 150 mg irbesartan once daily or placebo. Time to development of overt nephropathy, defined by persistent proteinuria, was the primary outcome measure.

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Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Type 2 Diabetes
  • Microalbuminuria
  • Hypertension
Drug: Irbesartan treatment
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Persson F, Rossing P, Hovind P, Stehouwer CD, Schalkwijk CG, Tarnow L, Parving HH. Endothelial dysfunction and inflammation predict development of diabetic nephropathy in the Irbesartan in Patients with Type 2 Diabetes and Microalbuminuria (IRMA 2) study. Scand J Clin Lab Invest. 2008;68(8):731-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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Inclusion Criteria:

Type 2 diabetes. Hypertension. Persistent microalbuminuria. Serum creatinine concentration of no more than 1.5 mg per deciliter (133 µmol per liter) for men and no more than 1.1 mg per deciliter (97 µmol per liter) for women. -

Exclusion Criteria:

Nondiabetic kidney disease. Cancer. Life-threatening disease with death expected to occur within two years. Indication for angiotensin-converting– enzyme (ACE) inhibitors or angiotensin-II–receptor antagonists. -

Both
30 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00317915
EFC2481
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Steno Diabetes Center
  • Bristol-Myers Squibb
  • Sanofi-Synthelabo
Principal Investigator: Hans-Henrik Parving, Prof. DMsc Steno Diabetes Center
Steno Diabetes Center
April 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP