Irbesartan in Type 2 Diabetes

• Sponsor: Steno Diabetes Center Copenhagen (Other)
• Overall Status: Completed
• CT.gov ID: NCT00317915
• Collaborator: Bristol-Myers Squibb (Industry), Sanofi-Synthelabo (Industry)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes; Microalbuminuria; Hypertension	Drug: Irbesartan treatment	Phase 3

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: The Irbesartan in Patients With Type 2 Diabetes and Microalbuminuria (IRMA 2)

Outcome Measures

Primary Outcome Measures

1. Development of overt nephropathy []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 70 Years
• Sexes Eligible for Study: All
• 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. -

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Steno Diabetes Center Copenhagen
• Bristol-Myers Squibb
• Sanofi-Synthelabo

Investigators

• Principal Investigator: Hans-Henrik Parving, Prof. DMsc, Steno Diabetes Center Copenhagen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00317915
• Other Study ID Numbers: EFC2481
• First Posted: Apr 25, 2006
• Last Update Posted: Apr 25, 2006
• Last Verified: Apr 1, 2006

• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Irbesartan

Study Results

No Results Posted as of Apr 25, 2006