Irbesartan in Type 2 Diabetes

Steno Diabetes Center Copenhagen

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Type 2 Diabetes Microalbuminuria Hypertension

Interventions

Irbesartan treatmentDRUG

Eligibility

Sex: ALLMin age: 30 YearsMax age: 70 Years

Medical Language ↔ Plain English

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. -

Outcomes

Primary Outcomes

Development of overt nephropathy

Data from ClinicalTrials.gov

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