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Irbesartan in Type 2 Diabetes

Primary Purpose

Type 2 Diabetes, Microalbuminuria, Hypertension

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Irbesartan treatment
Sponsored by
Steno Diabetes Center Copenhagen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. -

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Development of overt nephropathy

    Secondary Outcome Measures

    Full Information

    First Posted
    April 24, 2006
    Last Updated
    April 24, 2006
    Sponsor
    Steno Diabetes Center Copenhagen
    Collaborators
    Bristol-Myers Squibb, Sanofi-Synthelabo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00317915
    Brief Title
    Irbesartan in Type 2 Diabetes
    Official Title
    The Irbesartan in Patients With Type 2 Diabetes and Microalbuminuria (IRMA 2)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2006
    Overall Recruitment Status
    Completed
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Steno Diabetes Center Copenhagen
    Collaborators
    Bristol-Myers Squibb, Sanofi-Synthelabo

    4. Oversight

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 2 Diabetes, Microalbuminuria, Hypertension

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Irbesartan treatment
    Primary Outcome Measure Information:
    Title
    Development of overt nephropathy

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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. -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hans-Henrik Parving, Prof. DMsc
    Organizational Affiliation
    Steno Diabetes Center Copenhagen
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    32961617
    Citation
    Piazza 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.
    Results Reference
    derived
    PubMed Identifier
    18609080
    Citation
    Persson 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.
    Results Reference
    derived

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    Irbesartan in Type 2 Diabetes

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