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Irbesartan in Type 2 Diabetes

This study has been completed.
Bristol-Myers Squibb
Information provided by:
Steno Diabetes Center Identifier:
First received: April 24, 2006
Last updated: NA
Last verified: April 2006
History: No changes posted
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 Intervention Phase
Type 2 Diabetes Microalbuminuria Hypertension Drug: Irbesartan treatment Phase 3

Study Type: Interventional
Study Design: 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 NLM:

Further study details as provided by Steno Diabetes Center:

Primary Outcome Measures:
  • Development of overt nephropathy


Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
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. -

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Please refer to this study by its identifier: NCT00317915

Sponsors and Collaborators
Steno Diabetes Center
Bristol-Myers Squibb
Principal Investigator: Hans-Henrik Parving, Prof. DMsc Steno Diabetes Center
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00317915     History of Changes
Other Study ID Numbers: EFC2481
Study First Received: April 24, 2006
Last Updated: April 24, 2006

Additional relevant MeSH terms:
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 processed this record on September 21, 2017