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

NCT00557518 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2009-01-30

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 1
  • Diabetic Nephropathy

Interventions

DRUG

Alagebrium

200 mg bid

DRUG

Placebo

bid

Sponsors & Collaborators

  • Juvenile Diabetes Research Foundation

    collaborator OTHER
  • Synvista Therapeutics, Inc

    lead INDUSTRY

Principal Investigators

  • Mark E Cooper, MBBS, PhD · Baker Heart Research Institute, Melbourne, Australia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2009-09-30
Completion
2009-11-30

Countries

  • Australia
  • Denmark

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00557518 on ClinicalTrials.gov