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

• Status: Terminated
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Synvista Therapeutics, Inc
• Collaborator: Juvenile Diabetes Research Foundation

Criteria

Inclusion Criteria:

• Insulin-dependent type 1 diabetes

• Age 18-65 years

• Diagnosis of established microalbuminuria

• Blood pressure <140 mm Hg, diastolic blood pressure <90 mm Hg

• HbA1c <10%

Exclusion Criteria:

• 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

• Serum creatinine >1.5 mg/dL

• Receiving chronic nonsteroidal anti-inflammatory therapy

• Receiving antihypertensive therapy except for angiotensin converting enzyme inhibitors or angiotensin receptor blockers

• Any significant systemic illnesses,medical conditions or abnormal laboratory values