[Translation] A multicenter randomized, double-blind, double-dummy, positive drug parallel controlled clinical trial of Tangmai Jiaotai Capsule in the treatment of type 2 diabetes mellitus combined with hyperlipidemia with "stomach heat and kidney deficiency syndrome"
在已完成的II、III期临床试验基础上,以探索试验用药的有效性和安全性及中药复方制剂治疗2型糖尿病合并高脂血症的优势为目的,评价其降低或稳定血糖、降低血脂的疗效及使用过程的安全性,为试验药物注册审批提供依据。
[Translation] On the basis of completed Phase II and III clinical trials, with the purpose of exploring the effectiveness and safety of investigational drugs and the advantages of Chinese herbal compound preparations in treating type 2 diabetes mellitus complicated by hyperlipidemia, the efficacy of lowering or stabilizing blood sugar and lowering blood lipids as well as the safety of the use process are evaluated, so as to provide a basis for the registration and approval of investigational drugs.