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

NCT ID: NCT00557518

Last Updated: 2009-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2009-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diabetes Mellitus, Type 1 Diabetic Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type ACTIVE_COMPARATOR

Alagebrium

Intervention Type DRUG

200 mg bid

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

bid

Interventions

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Alagebrium

200 mg bid

Intervention Type DRUG

Placebo

bid

Intervention Type DRUG

Other Intervention Names

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ALT-711

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Juvenile Diabetes Research Foundation

OTHER

Sponsor Role collaborator

Synvista Therapeutics, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Baker Heart Research Institute, Melbourne, Australia

Principal Investigators

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Mark E Cooper, MBBS, PhD

Role: STUDY_CHAIR

Baker Heart Research Institute, Melbourne, Australia

Locations

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Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Site Status

International Diabetes Institute

Caulfield, Victoria, Australia

Site Status

Dept. of Clinical and Biomedical Science Myers House

Geelong, Victoria, Australia

Site Status

Austin Health

Heidelburg, Victoria, Australia

Site Status

The Alfred Hospital

Melbourne, Victoria, Australia

Site Status

Steno Diabetes Center

Gentofte Municipality, , Denmark

Site Status

Countries

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Australia Denmark

Other Identifiers

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ALT-711-0424

Identifier Type: -

Identifier Source: org_study_id