[Translation] A multicenter, randomized, open, positive-controlled Phase III clinical trial comparing the efficacy and safety of United Lab's insulin degludec injection and Tresiba® in the treatment of type 2 diabetes
本研究使用珠海联邦制药股份有限公司研制生产的德谷胰岛素注射液和诺和达®对2 型糖尿病患者进行为期24 周的治疗,比较治疗前后糖化血红蛋白(HbA1c)、空腹血糖下降和达标率等;同时比较两组低血糖事件的发生率和其它相关安全性指标及免疫原性指标相似性。主要目的是评价联邦制药研制的德谷胰岛素注射液对2 型糖尿病患者的有效性及安全性。
[Translation] This study used degludec insulin injection and Tresiba® developed and produced by Zhuhai United Pharmaceutical Co., Ltd. to treat patients with type 2 diabetes for 24 weeks, and compared the reduction and achievement rate of glycated hemoglobin (HbA1c) and fasting blood glucose before and after treatment; at the same time, the incidence of hypoglycemia and other related safety indicators and immunogenicity indicators were compared between the two groups. The main purpose is to evaluate the effectiveness and safety of degludec insulin injection developed by United Pharmaceutical in patients with type 2 diabetes.