Irbesartan in Type 2 Diabetes
The Irbesartan in Patients With Type 2 Diabetes and Microalbuminuria (IRMA 2)
1 other identifier
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2006
CompletedFirst Posted
Study publicly available on registry
April 25, 2006
CompletedApril 25, 2006
April 1, 2006
April 24, 2006
April 24, 2006
Conditions
Outcome Measures
Primary Outcomes (1)
Development of overt nephropathy
Interventions
Eligibility Criteria
You may qualify if:
- 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. -
You may not qualify if:
- 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. -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Steno Diabetes Center Copenhagenlead
- Bristol-Myers Squibbcollaborator
- Sanofi-Synthelabocollaborator
Related Publications (5)
Jongs N, Gasparyan SB, Frison L, Schloemer P, Brinker M, Little DJ, Heerspink HJL. Use of eGFR Slope Thresholds as End Point Components in a Kidney Disease Progression Hierarchical Composite End Point. J Am Soc Nephrol. 2025 Dec 1;36(12):2421-2430. doi: 10.1681/ASN.0000000766. Epub 2025 Jun 17.
PMID: 40526444DERIVEDNatale P, Palmer SC, Navaneethan SD, Craig JC, Strippoli GF. Angiotensin-converting-enzyme inhibitors and angiotensin receptor blockers for preventing the progression of diabetic kidney disease. Cochrane Database Syst Rev. 2024 Apr 29;4(4):CD006257. doi: 10.1002/14651858.CD006257.pub2.
PMID: 38682786DERIVEDHeerspink HJL, Jongs N, Schloemer P, Little DJ, Brinker M, Tasto C, Karpefors M, Wheeler DC, Bakris G, Perkovic V, Nkulikiyinka R, Rossert J, Gasparyan SB. Development and Validation of a New Hierarchical Composite End Point for Clinical Trials of Kidney Disease Progression. J Am Soc Nephrol. 2023 Dec 1;34(12):2025-2038. doi: 10.1681/ASN.0000000000000243. Epub 2023 Oct 24.
PMID: 37872654DERIVEDPiazza M, Hanssen NMJ, Persson F, Scheijen JL, van de Waarenburg MPH, van Greevenbroek MMJ, Rossing P, Hovind P, Stehouwer CDA, Parving HH, Schalkwijk CG. Irbesartan treatment does not influence plasma levels of the dicarbonyls methylglyoxal, glyoxal and 3-deoxyglucosone in participants with type 2 diabetes and microalbuminuria: An IRMA2 sub-study. Diabet Med. 2021 Sep;38(9):e14405. doi: 10.1111/dme.14405. Epub 2020 Oct 16.
PMID: 32961617DERIVEDPersson F, Rossing P, Hovind P, Stehouwer CD, Schalkwijk CG, Tarnow L, Parving HH. Endothelial dysfunction and inflammation predict development of diabetic nephropathy in the Irbesartan in Patients with Type 2 Diabetes and Microalbuminuria (IRMA 2) study. Scand J Clin Lab Invest. 2008;68(8):731-8. doi: 10.1080/00365510802187226.
PMID: 18609080DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hans-Henrik Parving, Prof. DMsc
Steno Diabetes Center Copenhagen
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 24, 2006
First Posted
April 25, 2006
Last Updated
April 25, 2006
Record last verified: 2006-04