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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00557518

Enrollment

Registered

2007-11-14

Start date

2007-11-30

Completion date

2009-11-30

Last updated

2009-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1, Diabetic Nephropathy

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.

Interventions

DRUGAlagebrium

200 mg bid

DRUGPlacebo

bid

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Change from baseline in albumin excretion rate (µg/min)	24 weeks

Secondary

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

Countries

Australia, Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026