Irbesartan in Type 2 Diabetes

This study has been completed.

Sponsors and Collaborators:	Steno Diabetes Center Bristol-Myers Squibb Sanofi-Synthelabo
Information provided by:	Steno Diabetes Center
ClinicalTrials.gov Identifier:	NCT00317915

Purpose

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 III

MedlinePlus related topics: Diabetes High Blood Pressure

Drug Information available for: Irbesartan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	The Irbesartan in Patients With Type 2 Diabetes and Microalbuminuria (IRMA 2)

Further study details as provided by Steno Diabetes Center:

Primary Outcome Measures:

Development of overt nephropathy

Eligibility

Ages Eligible for Study:	30 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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. -

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00317915

Sponsors and Collaborators

Steno Diabetes Center

Bristol-Myers Squibb

Sanofi-Synthelabo

Investigators

Principal Investigator:

Hans-Henrik Parving, Prof. DMsc

Steno Diabetes Center

More Information

Publications indexed to this study:

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.

Study ID Numbers:	EFC2481
Study First Received:	April 24, 2006
Last Updated:	April 24, 2006
ClinicalTrials.gov Identifier:	NCT00317915
Health Authority:	Denmark: Danish Medicines Agency

Study placed in the following topic categories:

Albuminuria
Metabolic Diseases
Urination Disorders
Irbesartan
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases
Angiotensin II

Signs and Symptoms
Proteinuria
Urologic Diseases
Diabetes Mellitus, Type 2
Endocrinopathy
Glucose Metabolism Disorders
Metabolic disorder
Hypertension

Additional relevant MeSH terms:

Angiotensin II Type 1 Receptor Blockers
Urological Manifestations
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009