Optimal Dose of Irbesartan for Renoprotection in Type 2 Diabetic Patients With Persistent Microalbuminuria

• Status: Completed
• Trial end date: 2004-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Aim: To evaluate the renoprotective effect as reflected by short-term changes in albuminuria of ultra high doses of irbesartan in Type 2 diabetic patients with microalbuminuria Design: A double-masked randomized cross-over trial including 60 hypertensive Type 2 diabetic patients with microalbuminuria on ongoing antihypertensive medication. At inclusion, previous antihypertensive treatment will be discontinued and replaced with bendroflumethiazide 5 mg o.d. for the entire study. Following two months wash-out (baseline), patients will be treated randomly with irbesartan 300, 600 and 900 mg o.d., each dose for two months. End-points evaluated at the end of each study period include urinary albumin excretion rate (UAE, mean of three 24-hrs collections), 24-hrs blood pressure (ABP); and GFR (51Cr-EDTA).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Steno Diabetes Center; Steno Diabetes Center Copenhagen
• Treatments: Irbesartan

Criteria

Inclusion Criteria:

• Type 2 diabetes (WHO criteria) and age above 18 years.

• Persistent microalbuminuria (urinary albumin excretion between 30 and 300 mg/24-h in at least two out of three 24-urinary collections

• Systolic blood pressure > 110 mmHg

Exclusion Criteria:

• Serum creatinine > 150 micromol/l

• Known non-diabetic renal disease

• Pregnancy or fertile women not using adequate contraception (intrauterine device, sterilization or oral anticonception)

• Systolic blood pressure persistently > 180 mm Hg or < 100 mm Hg

• Diastolic blood pressure persistently > 105 mm Hg

• Plasma potassium > 4.8 mmol/l

• Heart failure, acute myocardial infarction, unstable angina or coronary by-pass surgery within the previous three months.

• Known intolerance to angiotensin II receptor blockers