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

Sponsors and Collaborators:	Synvista Therapeutics, Inc Juvenile Diabetes Research Foundation
Information provided by:	Synvista Therapeutics, Inc
ClinicalTrials.gov Identifier:	NCT00557518

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 II

MedlinePlus related topics: Diabetes Diabetes Type 1 Diabetic Kidney Problems

Drug Information available for: Insulin Alagebrium chloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Placebo-Controlled Trial of Alagebrium in Patients With Insulin-Dependent Type 1 Diabetes and Microalbuminuria

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
1: Active Comparator	Drug: Alagebrium 200 mg bid
2: Placebo Comparator	Drug: Placebo bid

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

Contacts

Contact: Lisa Nelson

+61 3 9207 1917

Locations

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

Responsible Party:	Baker Heart Research Institute, Melbourne, Australia ( Mark Cooper )
Study ID Numbers:	ALT-711-0424
Study First Received:	November 12, 2007
Last Updated:	August 21, 2008
ClinicalTrials.gov Identifier:	NCT00557518
Health Authority:	Australia: Therapeutic Goods Administration; Denmark: Danish Medicines Agency

Study placed in the following topic categories:

Diabetic Nephropathies
Metabolic Diseases
Autoimmune Diseases
Diabetes Mellitus
Endocrine System Diseases
Insulin
Diabetes Mellitus, Type 1

Urologic Diseases
Kidney Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic disorder
Diabetes Complications

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 15, 2009