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

Primary Purpose

Diabetes Mellitus, Type 1, Diabetic Nephropathy

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Alagebrium

Placebo

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Royal Prince Alfred Hospital
International Diabetes Institute
Dept. of Clinical and Biomedical Science Myers House
Austin Health
The Alfred Hospital
Steno Diabetes Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in albumin excretion rate (µg/min)

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00557518

First Posted

November 12, 2007

Last Updated

January 29, 2009

Sponsor

Synvista Therapeutics, Inc

Collaborators

Juvenile Diabetes Research Foundation

1. Study Identification

Unique Protocol Identification Number

NCT00557518

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2009

Overall Recruitment Status

Terminated

Why Stopped

Study has been terminated early due to financial constraints.

Study Start Date

November 2007 (undefined)

Primary Completion Date

September 2009 (Anticipated)

Study Completion Date

November 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Synvista Therapeutics, Inc

Collaborators

Juvenile Diabetes Research Foundation

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 1, Diabetic Nephropathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Alagebrium

Other Intervention Name(s)

ALT-711

Intervention Description

200 mg bid

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

bid

Primary Outcome Measure Information:

Title

Change from baseline in albumin excretion rate (µg/min)

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

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

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark E Cooper, MBBS, PhD

Organizational Affiliation

Baker Heart Research Institute, Melbourne, Australia

Official's Role

Study Chair

Facility Information:

Facility Name

Royal Prince Alfred Hospital

City

Camperdown

State/Province

New South Wales

ZIP/Postal Code

2050

Country

Australia

Facility Name

International Diabetes Institute

City

Caulfield

State/Province

Victoria

ZIP/Postal Code

3162

Country

Australia

Facility Name

Dept. of Clinical and Biomedical Science Myers House

City

Geelong

State/Province

Victoria

ZIP/Postal Code

3220

Country

Australia

Facility Name

Austin Health

City

Heidelburg

State/Province

Victoria

ZIP/Postal Code

3084

Country

Australia

Facility Name

The Alfred Hospital

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3004

Country

Australia

Facility Name

Steno Diabetes Center

City

Gentofte

ZIP/Postal Code

DK-2820

Country

Denmark

12. IPD Sharing Statement

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

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