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

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00557518
• Other study ID #: ALT-711-0424
• Status: Terminated
• Phase: Phase 2
• First received: November 12, 2007
• Last updated: January 29, 2009
• Start date: November 2007
• Est. completion date: November 2009

Study information

• Verified date: January 2009
• Source: Synvista Therapeutics, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Therapeutic Goods AdministrationDenmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: November 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Diabetic Nephropathies
• Diabetic Nephropathy

Intervention

Drug:
• Alagebrium
200 mg bid
• Placebo
bid

Locations

Country	Name	City	State
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	International Diabetes Institute	Caulfield	Victoria
Australia	Dept. of Clinical and Biomedical Science Myers House	Geelong	Victoria
Australia	Austin Health	Heidelburg	Victoria
Australia	The Alfred Hospital	Melbourne	Victoria
Denmark	Steno Diabetes Center	Gentofte

Sponsors (2)

Lead Sponsor	Collaborator
Synvista Therapeutics, Inc	Juvenile Diabetes Research Foundation

Countries where clinical trial is conducted

Australia,  Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in albumin excretion rate (µg/min)		24 weeks	No
Secondary	Albumin:creatinine ratio(mg/g), plasma renin level, collagen markers, AGE related markers, 24 hour blood pressure determinations		24 weeks	No