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

This study has been terminated.
(Study has been terminated early due to financial constraints.)
Sponsor:
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by:
Synvista Therapeutics, Inc
ClinicalTrials.gov Identifier:
NCT00557518
First received: November 12, 2007
Last updated: January 29, 2009
Last verified: January 2009
History of Changes
  Purpose

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 Intervention Phase
Diabetes Mellitus, Type 1
Diabetic Nephropathy
 Drug: Alagebrium
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Synvista Therapeutics, Inc:

Primary Outcome Measures:
  • Change from baseline in albumin excretion rate (µg/min) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Albumin:creatinine ratio(mg/g), plasma renin level, collagen markers, AGE related markers, 24 hour blood pressure determinations [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: November 2007
Estimated Study Completion Date: November 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: Alagebrium
200 mg bid
Other Name: ALT-711
Placebo Comparator: 2 Drug: Placebo
bid
Other Name: Placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00557518

Locations
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
Denmark
Steno Diabetes Center
Gentofte, Denmark, DK-2820
Sponsors and Collaborators
Synvista Therapeutics, Inc
Juvenile Diabetes Research Foundation
Investigators
Study Chair: Mark E Cooper, MBBS, PhD Baker Heart Research Institute, Melbourne Australia
  More Information

No publications provided

Responsible Party: Mark Cooper, Baker Heart Research Institute, Melbourne, Australia
ClinicalTrials.gov Identifier: NCT00557518     History of Changes
Other Study ID Numbers: ALT-711-0424
Study First Received: November 12, 2007
Last Updated: January 29, 2009
Health Authority: Australia: Therapeutic Goods Administration
Denmark: Danish Medicines Agency

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

ClinicalTrials.gov processed this record on May 21, 2013