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

Phase 2

Terminated

• Conditions: Diabetes Mellitus, Type 1; Diabetic Nephropathy
• Interventions: Drug: Placebo; Drug: Alagebrium

• Registration Number: NCT00557518
• Lead Sponsor: Synvista Therapeutics, Inc

Brief 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.

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-11-12
• Study First Submitted QC: 2007-11-13
• Study First Posted: 2007-11-14
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-29
• Last Update Posted: 2009-01-30
• Primary Completion: 2009-09
• Study Completion: 2009-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	-
1	Alagebrium	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in albumin excretion rate (µg/min)	24 weeks

Secondary Outcome Measures

Name	Time	Method
Albumin:creatinine ratio(mg/g), plasma renin level, collagen markers, AGE related markers, 24 hour blood pressure determinations	24 weeks

Trial Locations

Locations (6)

Dept. of Clinical and Biomedical Science Myers House; 🇦🇺 Geelong, Victoria, Australia

The Alfred Hospital; 🇦🇺 Melbourne, Victoria, Australia

Austin Health; 🇦🇺 Heidelburg, Victoria, Australia

Royal Prince Alfred Hospital; 🇦🇺 Camperdown, New South Wales, Australia

International Diabetes Institute; 🇦🇺 Caulfield, Victoria, Australia

Steno Diabetes Center; 🇩🇰 Gentofte, Denmark