Irbesartan in Type 2 Diabetes
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | April 24, 2006 | ||||
| Last Updated Date | April 24, 2006 | ||||
| Start Date ICMJE | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Development of overt nephropathy | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Irbesartan in Type 2 Diabetes | ||||
| Official Title ICMJE | The Irbesartan in Patients With Type 2 Diabetes and Microalbuminuria (IRMA 2) | ||||
| 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. |
||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE | Drug: Irbesartan treatment | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | 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. | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | Not Provided | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | 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. - |
||||
| Gender | Both | ||||
| Ages | 30 Years to 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00317915 | ||||
| Other Study ID Numbers ICMJE | EFC2481 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Steno Diabetes Center | ||||
| Collaborators ICMJE |
|
||||
| Investigators ICMJE |
|
||||
| Information Provided By | Steno Diabetes Center | ||||
| Verification Date | April 2006 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||