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

Conditions: This is a double-blind phase 2 clinical study to evaluate the effects of alagebrium chloride (ALT-711) versus placebo on albumin excretion rate (as an early marker of diabetic nephropathy) in subjects with type 1 diabetes with microalbuminuria receiving concomitant antihypertensive therapy.
MedDRA version: 9.1Level: LLTClassification code 10061835Term: Diabetic nephropathy

Registration Number: EUCTR2006-003618-17-DK

Lead Sponsor: JDRF Danielle Alberti Memorial Centre For Diabetes Complications Baker Heart Research Institute

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 80

Inclusion Criteria

-Insulin-dependent type 1 diabetes
-Age 18-65
-Diagnosis of established microalbuminuria (albumin:creatinine ratio = 30-300 mg/g) by at least 2 independent analyses over a period 6 months or at least 3 independent analyses over a period of at least 12 months prior to screening and confirmed at screening
-Presence of microalbuminuria reconfirmed at baseline, visit 3 (albumin:creatinine ratio = 30-300 mg/g)
-Office cuff systolic blood pressure less than or equal to 140 mm Hg, diastolic blood pressure less than or equal to 90 mm Hg
-HbAlc less than 10%
-The subject is able to understand content of and has provided written informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Body mass index greater than 40 kg/m^2.
-Cardiovascular event within 6 months prior to screening, including angina, or any revascularization procedures
-History of acute myocardial infarction within 12 months prior to screening.
-Receiving chronic nonsteroidal anti-inflammatory (NSAID) therapay.
-Receiving antihypertensive therapy except for angiotensin-coverting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs).
-Use of systemic corticosteriods (topical and inhaled corticosteriods are permitted)
-Stroke or any sequelae of a stroke, transient ischemic attack, or reversible ischemic neurological defect within 24 months prior to screening.
-Any significant ECG abnormalities, including second-degree A-V block or complete A-V block. Any known significant arrhythmia including atrial flutter, ventricular tachycardia, WPW syndrome. Any hemodynamically significant valvular heart disease.

See protocol for additional exclusion criteria.