NCT00557518

Study of Alagebrium in Patients With Insulin-Dependent Type 1 Diabetes and Microalbuminuria

A Randomized, Placebo-Controlled Trial of Alagebrium in Patients With Insulin-Dependent Type 1 Diabetes and Microalbuminuria

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Synvista Therapeutics, Inc · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Diabetes Mellitus, Type 1
• Diabetic Nephropathy

Interventions

Type	Name	Description
DRUG	Alagebrium	200 mg bid
DRUG	Placebo	bid

Timeline

• Start date: 2007-11-01
• Primary completion: 2009-09-01
• Completion: 2009-11-01
• First posted: 2007-11-14
• Last updated: 2009-01-30

Locations

6 sites across 2 countries: Australia, Denmark