PLACEBO CONTROLLED SAFETY AND EFFICACY OF AMINOGUANIDINE IN DIABETIC PATIENTS

我们计划使用安慰剂、2种不同剂量的氨基胍（以干扰产品中晚期糖基化的产生）以随机方式研究伴有明显肾病的I型糖尿病患者，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人群中的安全性。 1998年7月和8月对所有受试者进行了研究结束访视。 随后，对方案进行了修订，允许合格受试者选择继续接受设盲研究药物，直至1999年3月。 继续服用设盲研究药物的受试者每三个月接受一次安全性评价随访。 研究药物的安全性和有效性的最终结果尚未公布。

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.