[Translation] A multicenter, randomized, open, positive-controlled Phase III clinical trial comparing the efficacy and safety of semaglutide injection from United Biopharma and Novotel® in the treatment of type 2 diabetes
本研究使用联邦生物科技(珠海横琴)有限公司研制的司美格鲁肽注射液和诺和诺德公司生产的司美格鲁肽注射液(商品名:诺和泰®)对2型糖尿病患者进行为期32周的治疗,比较治疗前后糖化血红蛋白、空腹血糖的下降和达标率,以及体重等变化;同时比较两组低血糖事件、胃肠道事件的发生率和其他相关安全性指标及免疫原性指标,以及两组药代动力学的相似性。主要目的是评价联邦生物研制的司美格鲁肽注射液与诺和泰®对2型糖尿病患者的有效性和安全性的相似性。
[Translation] This study used semaglutide injection developed by United Biotech (Zhuhai Hengqin) Co., Ltd. and semaglutide injection (trade name: Novo Nordisk®) to treat patients with type 2 diabetes for 32 weeks, and compared the decrease and target rate of glycated hemoglobin and fasting blood glucose before and after treatment, as well as changes in body weight; at the same time, the incidence of hypoglycemia, gastrointestinal events and other related safety indicators and immunogenicity indicators were compared between the two groups, as well as the similarity of pharmacokinetics between the two groups. The main purpose is to evaluate the similarity of the effectiveness and safety of semaglutide injection developed by United Biotech and Novo Nordisk® in patients with type 2 diabetes.