ALT-711-0424

About this trial

Last updated 16 years ago

Study ID

ALT-711-0424

Status

Terminated

Type

Interventional

Phase

Phase 2

Placebo

Yes

Accepting

18 to 65 Years

All

Not accepting

Healthy Volunteers

Trial Timing

Ended 16 years ago

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.

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

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