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

Synvista Therapeutics

Status and phase: Terminated; Phase 2

Conditions: Diabetic Nephropathy; Diabetes Mellitus, Type 1

Treatments: Drug: Placebo; Drug: Alagebrium

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00557518

ALT-711-0424

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Treatment:

Drug: Alagebrium

2

Placebo Comparator group

Treatment:

Drug: Placebo