[Translation] A multi-center, randomized, open-label, parallel-controlled phase III clinical trial to evaluate the efficacy and safety of semaglutide injection (HD1916) and Novotel® in patients with type 2 diabetes
主要目的:
在接受盐酸二甲双胍治疗的2型糖尿病患者中,证明司美格鲁肽注射液(HD1916)与诺和泰®治疗后第32周时降低HbA1c的疗效相似性。
次要目的:
在接受盐酸二甲双胍治疗的2型糖尿病患者中,比较司美格鲁肽注射液(HD1916)与诺和泰®治疗后其他疗效终点的相似性、安全性和免疫原性、PK特征。
[Translation] main purpose:
In patients with type 2 diabetes treated with metformin hydrochloride, the efficacy of semaglutide injection (HD1916) and Novotel® in reducing HbA1c at week 32 was demonstrated to be similar.
Secondary purpose:
In patients with type 2 diabetes treated with metformin hydrochloride, the similarity, safety, immunogenicity, and PK characteristics of other efficacy endpoints after treatment with semaglutide injection (HD1916) and Novotel® were compared.