Study of Alagebrium in Patients With Insulin-Dependent Type 1 Diabetes and Microalbuminuria
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ClinicalTrials.gov Identifier: NCT00557518
(Study has been terminated early due to financial constraints.)
Based upon the preclinical evidence in models of diabetic nephropathy under conditions approximating both type I and II diabetes, treatment with alagebrium appears to have favorable and advantageous effects on the biochemical, structural, pathological and functional hallmarks of diabetic nephropathy. The renoprotective effects of alagebrium in preclinical models favor the evaluation of this drug in patients with type I diabetes.
Condition or disease
Diabetes Mellitus, Type 1Diabetic Nephropathy
Drug: AlagebriumDrug: Placebo
This study is a double-blind, randomized, placebo-controlled, parallel design trial enrolling 80 patients (2x40) with Type 1 diabetes and microalbuminuria. Patients will be randomized to either 200 mg Alagebrium twice daily or placebo for a period of 24 weeks after an 8 week run-in period. There will be a 8 week run-out period. All patients will receive ramipril during the entire study period. Efficacy measurements will be performed at baseline, at 12 weeks and at the end of the study. Measurements for albumin:creatinine ratio(mg/g), plasma renin level, collagen markers, AGE related markers and 24 hour blood pressure measurements will also be determined. A total of 9 visits will be performed during the entire study.
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Ages Eligible for Study:
18 Years to 65 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Insulin-dependent type 1 diabetes
Age 18-65 years
Diagnosis of established microalbuminuria
Blood pressure <140 mm Hg, diastolic blood pressure <90 mm Hg
Body mass index >40 kg/m2
Cardiovascular event within 6 months prior to screening
History of acute myocardial infarction within 12 months prior to screening