PLACEBO CONTROLLED SAFETY AND EFFICACY OF AMINOGUANIDINE IN DIABETIC PATIENTS

我们计划以随机方式研究伴有显性肾病的I型糖尿病患者，使用安慰剂、氨基胍2种不同剂量（以干扰产品中晚期糖基化的产生），并评估阻断蛋白质交联对糖尿病肾病进展的影响，以及评估氨基胍在该患者群体中的安全性。在1998年7月和8月对所有受试者进行了研究访问。随后，该方案被修改，允许符合条件的受试者选择继续服用盲法研究药物，直到1999年3月。继续服用盲法研究药物的受试者每三个月进行一次安全性评估。研究药物的安全性和有效性的最终结果正在等待中。

We plan to study type I diabetic patients with overt nephropathy in a randomized fashion using placebo, aminoguanidine 2 different doses (to interfere with the production of advanced glycosylation in products) and assess the effect of blockage of crosslinking of proteins on the progression of diabetic nephropathy as well as to assess the safety of aminoguanidine in this population of patients. End of study visits were conducted on all subjects in July and August 1998. Subsequently, the protocol was amended to allow eligible subjects the option of continuing to take blinded study medication until March 1999. Subjects who continue to take blinded study drug are being followed every three months for safety evaluations. Final results of the study drug's safety and efficacy are pending.