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

January 29, 2009 updated by: Synvista Therapeutics, Inc

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
    • Victoria
      • Caulfield, Victoria, Australia, 3162
        • International Diabetes Institute
      • Geelong, Victoria, Australia, 3220
        • Dept. of Clinical and Biomedical Science Myers House
      • Heidelburg, Victoria, Australia, 3084
        • Austin Health
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital
  • Denmark
      • Gentofte, Denmark, DK-2820
        • Steno Diabetes Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Drug: Placebo
bid
Active Comparator: 1
Drug: Alagebrium
200 mg bid
Other Names:
  • ALT-711

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in albumin excretion rate (µg/min)
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Synvista Therapeutics, Inc

Collaborators

Juvenile Diabetes Research Foundation

Investigators

  • Study Chair: Mark E Cooper, MBBS, PhD, Baker Heart Research Institute, Melbourne, Australia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Anticipated)

September 1, 2009

Study Completion (Anticipated)

November 1, 2009

Study Registration Dates

First Submitted

November 12, 2007

First Submitted That Met QC Criteria

November 13, 2007

First Posted (Estimate)

November 14, 2007

Study Record Updates

Last Update Posted (Estimate)

January 30, 2009

Last Update Submitted That Met QC Criteria

January 29, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALT-711-0424

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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