Linong Ji, Leili Gao, Zhifeng Cheng, Guoqing Ma, Shu Li, Haifang Wang, Jie Liu, Yibing Lu, Meiying Liu, Jianlin Geng, Yunming Gao, Hongwei Ling, Wenli Sun, Chengwei Song, Jingfang Sun
OBJECTIVE: To compare the efficacy and safety of insulin degludec biosimilar B01411 (HS-IDeg) with originator insulin degludec-Tresiba (NN-IDeg) in Chinese patients with type 2 diabetes mellitus (T2DM) who were inadequately controlled on oral antidiabetic drugs (OADs) for at least 3 months. METHODS: This multicenter, randomized, open-label, parallel-group, active-controlled, phase 3 study enrolled 362 participants with T2DM. Participants were stratified according to whether the insulin secretagogue (sulfonylurea or glinide) had been used before the screening and then randomized 1:1 to receive once-daily subcutaneous injections of HS-IDeg (n = 180) or NN-IDeg (n = 182) for 18 weeks...
September 5, 2024: Current Medical Research and Opinion