The primary efficacy endpoints included improvement of Michigan Diabetic Neuropathy Score (MDNS), and the secondary efficacy endpoints were the changes in neuropathy and nerve conduction velocity (NCV).

• 主要观察指标为神经体征(密西根糖尿病神经评分,MDNS),辅助观察指标为神经症状(自觉感觉异常)和神经传导速度(NCV)。