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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00557518
Recruitment Status : Terminated (Study has been terminated early due to financial constraints.)
First Posted : November 14, 2007
Last Update Posted : January 30, 2009
Juvenile Diabetes Research Foundation
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Diabetic Nephropathy Drug: Alagebrium Drug: Placebo Phase 2

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  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled Trial of Alagebrium in Patients With Insulin-Dependent Type 1 Diabetes and Microalbuminuria
Study Start Date : November 2007
Estimated Primary Completion Date : September 2009
Estimated Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1 Drug: Alagebrium
200 mg bid
Other Name: ALT-711

Placebo Comparator: 2 Drug: Placebo

Primary Outcome Measures :
  1. Change from baseline in albumin excretion rate (µg/min) [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Albumin:creatinine ratio(mg/g), plasma renin level, collagen markers, AGE related markers, 24 hour blood pressure determinations [ Time Frame: 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00557518

Australia, New South Wales
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Australia, Victoria
International Diabetes Institute
Caulfield, Victoria, Australia, 3162
Dept. of Clinical and Biomedical Science Myers House
Geelong, Victoria, Australia, 3220
Austin Health
Heidelburg, Victoria, Australia, 3084
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Steno Diabetes Center
Gentofte, Denmark, DK-2820
Sponsors and Collaborators
Synvista Therapeutics, Inc
Juvenile Diabetes Research Foundation
Study Chair: Mark E Cooper, MBBS, PhD Baker Heart Research Institute, Melbourne, Australia

Responsible Party: Mark Cooper, Baker Heart Research Institute, Melbourne, Australia Identifier: NCT00557518     History of Changes
Other Study ID Numbers: ALT-711-0424
First Posted: November 14, 2007    Key Record Dates
Last Update Posted: January 30, 2009
Last Verified: January 2009

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetic Nephropathies
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Kidney Diseases
Urologic Diseases
Diabetes Complications