[Translation] A multicenter, randomized, open-label, positive-controlled phase III clinical trial compared the efficacy and safety of Degludec-Aspart dual insulin and Novogene® in the treatment of 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,评价联邦生物研制的德谷门冬双胰岛素注射液在成人2型糖尿病患者中的有效性和安全性。 次要目的:评价德谷门冬双胰岛素注射液连续给药24周的安全性;评价德谷门冬双胰岛素注射液在2型糖尿病患者中的药代动力学特征;评价2型糖尿病患者多次皮下注射德谷门冬双胰岛素注射液后的免疫原性。
[Translation] Primary objective: To evaluate the efficacy and safety of Degludec-Aspart Insulin Injection (Novogene®) developed by Federal Bio in adult patients with type 2 diabetes, using the original drug as a control. Secondary objectives: To evaluate the safety of continuous administration of Degludec-Aspart Insulin Injection for 24 weeks; to evaluate the pharmacokinetic characteristics of Degludec-Aspart Insulin Injection in patients with type 2 diabetes; and to evaluate the immunogenicity of Degludec-Aspart Insulin Injection after multiple subcutaneous injections in patients with type 2 diabetes.