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: 9.1 Level: LLT Classification code 10061835 Term: Diabetic nephropathy
Conditions
Interventions
Product Name: Alagebrium Chloride
Product Code: ALT-711
Pharmaceutical Form: Tablet
INN or Proposed INN: Alagebrium chloride
CAS Number: 341028-37-3
Current Sponsor code: ALT-711
Concentration unit: m
Sponsors
JDRF Danielle Alberti Memorial Centre For Diabetes Complications Baker Heart Research Institute
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this double-blind phase 2 clinical study is 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 (ramipril).;Secondary Objective: The secondary objectives of this study are to evaluate the safety of alagebrium in combination with ramipril and the effects of the combination on kidney fibrosis (by measuring markers of collagen turnover), the renin-angiotensin pathway, and 24-hour mean blood pressure measured with an ambulatory blood pressure monitoring device.;Primary end point(s): Change from baseline in albumin excretion rate (ug/min) (based on 3 overight urine collections) after 24 weeks will be the primary measure of efficacy. | — |
Countries
Denmark
Outcome results
None listed