[Translation] A multicenter, randomized, open, parallel controlled study to compare the efficacy and safety of degludec and insulin aspart injection (CA508 injection) and Tresiba® in the treatment of patients with type 2 diabetes
主要目的:以原研药物德谷门冬双胰岛素注射液(诺和佳®)为对照,评价重庆宸安生物制药有限公司研制的德谷门冬双胰岛素注射液(CA508注射液)在成人2型糖尿病患者中的有效性。
次要目的: 1) 以原研药物德谷门冬双胰岛素注射液(诺和佳®)为对照,评价重庆宸安生物制药有限公司研制的德谷门冬双胰岛素注射液(CA508注射液)在成人2型糖尿病患者中的安全性。2) 比较德谷门冬双胰岛素注射液(CA508注射液)和诺和佳®在成人2型糖尿病患者中多次给药后关键PK参数的相似性。
[Translation] Primary objective: To evaluate the effectiveness of the original drug degludec aspart dual insulin injection (CA508 injection) developed by Chongqing Chenan Biopharmaceutical Co., Ltd. in adult patients with type 2 diabetes, using the original drug degludec aspart dual insulin injection (Novogar®) as a control.
Secondary objectives: 1) To evaluate the safety of the original drug degludec aspart dual insulin injection (CA508 injection) developed by Chongqing Chenan Biopharmaceutical Co., Ltd. in adult patients with type 2 diabetes, using the original drug degludec aspart dual insulin injection (Novogar®) as a control. 2) To compare the similarity of key PK parameters of degludec aspart dual insulin injection (CA508 injection) and Novogar® in adult patients with type 2 diabetes after multiple administration.