Irbesartan in Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborators:
Bristol-Myers Squibb
Sanofi-Synthelabo
Information provided by:
Steno Diabetes Center
ClinicalTrials.gov Identifier:
NCT00317915
First received: April 24, 2006
Last updated: NA
Last verified: April 2006
History: No changes posted
  Purpose

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 Intervention Phase
Type 2 Diabetes
Microalbuminuria
Hypertension
Drug: Irbesartan treatment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Irbesartan in Patients With Type 2 Diabetes and Microalbuminuria (IRMA 2)

Resource links provided by NLM:


Further study details as provided by Steno Diabetes Center:

Primary Outcome Measures:
  • Development of overt nephropathy

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00317915

Sponsors and Collaborators
Steno Diabetes Center
Bristol-Myers Squibb
Sanofi-Synthelabo
Investigators
Principal Investigator: Hans-Henrik Parving, Prof. DMsc Steno Diabetes Center
  More Information

No publications provided by Steno Diabetes Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00317915     History of Changes
Other Study ID Numbers: EFC2481
Study First Received: April 24, 2006
Last Updated: April 24, 2006
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypertension
Albuminuria
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Proteinuria
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Irbesartan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014