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NCT00317915 Clinical Trial

Irbesartan in Type 2 Diabetes

Hypertension Clinical Trial

Official title:
The Irbesartan in Patients With Type 2 Diabetes and Microalbuminuria (IRMA 2)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00317915
Other study ID # EFC2481
Secondary ID
Status Completed
Phase Phase 3
First received April 24, 2006
Last updated April 24, 2006

Study information
Verified date April 2006
Source Steno Diabetes Center
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Medicines Agency
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 30 Years to 70 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Irbesartan treatment

Locations
Country Name City State
n/a

Sponsors (3)
Lead Sponsor Collaborator
Steno Diabetes Center Bristol-Myers Squibb, Sanofi-Synthelabo

Outcome
Type Measure Description Time frame Safety issue
Primary Development of overt nephropathy
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