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多中心、随机、开放、阳性对照的Ⅲ期临床试验比较联邦生物德谷胰岛素利拉鲁肽注射液和诺和益®治疗2型糖尿病的有效性和安全性
[Translation] A multicenter, randomized, open, positive-controlled phase III clinical trial comparing the efficacy and safety of United Biopharma's insulin degludec liraglutide injection and NovoX® in the treatment of type 2 diabetes
研究联邦生物研制的德谷胰岛素利拉鲁肽注射液对2型糖尿病患者的有效性及安全性。
[Translation] To study the efficacy and safety of degludec insulin liraglutide injection developed by United Biotechnology in patients with type 2 diabetes.
随机、开放、两周期、自身交叉对照设计,评价空腹状态下德谷胰岛素利拉鲁肽注射液与“诺和益®”在中国健康受试者中的药代动力学和安全性比对试验
[Translation] A randomized, open-label, two-period, self-crossover controlled trial to evaluate the pharmacokinetics and safety of insulin degludec liraglutide injection and NovoX® in healthy Chinese subjects under fasting conditions
主要目的为考察德谷胰岛素利拉鲁肽注射液的药动学特征,比较中国健康成年受试者单次皮下注射德谷胰岛素利拉鲁肽(受试制剂)与原研药“诺和益®”(参比制剂)的药动学相似性。次要目的为评价德谷胰岛素利拉鲁肽注射液的安全性和初步评价免疫原性。
[Translation] The primary objective is to investigate the pharmacokinetic characteristics of degludec insulin liraglutide injection and to compare the pharmacokinetic similarity of a single subcutaneous injection of degludec insulin liraglutide (test preparation) with the original drug "NovoElix®" (reference preparation) in healthy Chinese adult subjects. The secondary objective is to evaluate the safety of degludec insulin liraglutide injection and preliminarily evaluate its immunogenicity.
多中心、随机、开放、阳性对照的Ⅲ期临床试验比较联邦生物司美格鲁肽注射液和诺和泰®治疗2型糖尿病的有效性和安全性
[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.
100 Clinical Results associated with Zhuhai Federal Biomedical Co., Ltd.
0 Patents (Medical) associated with Zhuhai Federal Biomedical Co., Ltd.
100 Deals associated with Zhuhai Federal Biomedical Co., Ltd.
100 Translational Medicine associated with Zhuhai Federal Biomedical Co., Ltd.