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Irbesartan in Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00317915
Recruitment Status : Completed
First Posted : April 25, 2006
Last Update Posted : April 25, 2006
Bristol-Myers Squibb
Information provided by:
Steno Diabetes Center Copenhagen

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Microalbuminuria Hypertension Drug: Irbesartan treatment Phase 3

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Irbesartan in Patients With Type 2 Diabetes and Microalbuminuria (IRMA 2)

Resource links provided by the National Library of Medicine

Drug Information available for: Irbesartan

Primary Outcome Measures :
  1. Development of overt nephropathy

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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. -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00317915

Sponsors and Collaborators
Steno Diabetes Center Copenhagen
Bristol-Myers Squibb
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Principal Investigator: Hans-Henrik Parving, Prof. DMsc Steno Diabetes Center Copenhagen
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00317915    
Other Study ID Numbers: EFC2481
First Posted: April 25, 2006    Key Record Dates
Last Update Posted: April 25, 2006
Last Verified: April 2006
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action