PLACEBO CONTROLLED SAFETY/EFFICACY STUDY OF AMINOGUANIDINE IN DIABETIC PATIENTS

氨基胍在糖尿病患者中的安慰剂对照安全性/有效性研究

• 批准号: 6219250
• 负责人: TREVOR J. ORCHARD
• 金额: $ 0.3万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6219250
• 关键词: aminoguanidine; clinical research; diabetic nephropathy; drug adverse effect; drug screening /evaluation; human subject; human therapy evaluation; insulin dependent diabetes mellitus; kidney disorder chemotherapy; kidney function; kidney imaging /visualization; medical complication; radiography; urinalysis

The primary objective of this trial is to evaluate the safety & efficacy of aminoguanidine in preserving renal function in patients with insulin dependent diabetes mellitus & overt diabetic nephropathy. Secondary; 1)to evaluate the effect of aminoguanidine on protein crosslinking in diabetic pts as measured by circulating blood and urinary concentrations of advanced glycated endproducts (AGEs),2) to evaluate the relationship between plasma aminoguanidine concentra-tions and primary and secondary efficacy endpoints as well as adverse events...

本试验的主要目的是评估氨基胍在胰岛素依赖型糖尿病和显性糖尿病肾病患者中维持肾功能的安全性和有效性。二次;1)评估氨基胍对糖尿病患者晚期糖基化终产物（AGEs）的循环血液和尿液浓度的影响，2)评估血浆氨基胍浓度与主要和次要疗效终点以及不良事件之间的关系。