Clinical trial NCT00557518: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 1
Diabetic Nephropathy
Lead sponsor: Synvista Therapeutics, Inc
Sponsor class: INDUSTRY
Collaborators: name: Juvenile Diabetes Research Foundation
First posted: 2007-11-14
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline in albumin excretion rate (µg/min)
timeFrame: 24 weeks
Secondary outcomes:
measure: Albumin:creatinine ratio(mg/g), plasma renin level, collagen markers, AGE related markers, 24 hour blood pressure determinations
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Caulfield
country: Australia
facility: International Diabetes Institute
state: Victoria
city: Geelong
country: Australia
facility: Dept. of Clinical and Biomedical Science Myers House
state: Victoria
city: Heidelburg
country: Australia
facility: Austin Health
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Gentofte
country: Denmark
facility: Steno Diabetes Center
Study officials:
affiliation: Baker Heart Research Institute, Melbourne, Australia
name: Mark E Cooper, MBBS, PhD
role: STUDY_CHAIR
References: