A Randomized, Placebo-Controlled Trial of Alagebrium in Patients With Insulin-Dependent Type 1 Diabetes and Microalbuminuria
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 80
- 试验地点
- 6
- 主要终点
- Change from baseline in albumin excretion rate (µg/min)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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%
排除标准
- •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
研究组 & 干预措施
1
干预措施: Alagebrium (Drug)
2
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in albumin excretion rate (µg/min)
时间窗: 24 weeks
次要结局
- Albumin:creatinine ratio(mg/g), plasma renin level, collagen markers, AGE related markers, 24 hour blood pressure determinations(24 weeks)