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Sponsors and Collaborators: |
Steno Diabetes Center Bristol-Myers Squibb Sanofi-Synthelabo |
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Information provided by: | Steno Diabetes Center |
ClinicalTrials.gov Identifier: | NCT00317915 |
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 |
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Type 2 Diabetes Microalbuminuria Hypertension |
Drug: Irbesartan treatment |
Phase III |
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) |
Ages Eligible for Study: | 30 Years to 70 Years |
Genders Eligible for Study: | Both |
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. -
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 |
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 |
Angiotensin II Type 1 Receptor Blockers Urological Manifestations Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Cardiovascular Diseases Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |