Irbesartan in Type 2 Diabetes

Steno Diabetes Centers

Status and phase

Completed

Phase 3

Conditions

Hypertension

Microalbuminuria

Type 2 Diabetes

Treatments

Drug: Irbesartan treatment

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00317915

EFC2481

Details and patient eligibility

About

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.

Sex

All

Ages

30 to 70 years old

Volunteers

No Healthy Volunteers

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. -