Journal of diabetes investigation · 2025
Efficacy and safety of insulin degludec/insulin aspart biosimilar B01711 vs originator insulin degludec/insulin aspart in Chinese patients with type 2 diabetes inadequately controlled on basal or premixed insulin: A multicenter, randomized, open-label, phase 3 study.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеКлиническое исследование III фазыСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Gao Leili, Cheng Zhifeng, Ma Guoqing, Cai Xiaojun, Wang Xiaoyun, Lu Yibing, Li Ziling, Li Wei, Zhao Shuping, Li Xuefeng, Song Chengwei, Gao Yunming, Geng Jianlin, Cao Haiyan, Sun Jingfang, Ji Linong
Аннотация
AIMS: To compare the efficacy and safety of insulin degludec/insulin aspart biosimilar B01711 (HS-IDegAsp) with originator insulin degludec/insulin aspart-Ryzodeg (NN-IDegAsp) in Chinese patients with type 2 diabetes mellitus (T2DM) who were inadequately controlled on once- or twice-daily (BID) premixed or basal insulin ± oral antidiabetic drugs (OADs).
MATERIALS AND METHODS: In this multicenter, randomized, open-label, parallel-group, active-controlled, phase 3 study, 367 participants with T2DM were randomized 1:1 to receive BID injections of HS-IDegAsp (n = 183) or NN-IDegAsp (n = 184) for 24 weeks. Insulins were administered subcutaneously with breakfast and the main evening meal at the same titration target. The primary endpoint was the change from baseline in glycated hemoglobin (HbA1c) to week 24.
RESULTS: At Week 24, the least squares (LS) mean change in HbA1c from baseline was -1.12% (95% CI -1.24 to -1.01) and -1.23% (95% CI -1.34 to -1.11) with HS-IDegAsp and NN-IDegAsp, respectively. The LS mean difference (HS-IDegAsp minus NN-IDegAsp) at Week 24 was 0.10% (95% CI -0.06 to 0.27), demonstrating that HS-IDegAsp was non-inferior to NN-IDegAsp. There was no statistically significant difference (P > 0.05) in fasting plasma glucose or proportion of patients achieving HbA1c < 7.0% at Week 24 between both groups. Safety and immunogenicity were similar between both groups.
CONCLUSIONS: HS-IDegAsp demonstrated comparable efficacy and safety to NN-IDegAsp during the 24-week treatment period in Chinese patients with inadequately controlled T2DM previously treated on once- or twice-daily premixed or basal insulin, with or without OADs.
MATERIALS AND METHODS: In this multicenter, randomized, open-label, parallel-group, active-controlled, phase 3 study, 367 participants with T2DM were randomized 1:1 to receive BID injections of HS-IDegAsp (n = 183) or NN-IDegAsp (n = 184) for 24 weeks. Insulins were administered subcutaneously with breakfast and the main evening meal at the same titration target. The primary endpoint was the change from baseline in glycated hemoglobin (HbA1c) to week 24.
RESULTS: At Week 24, the least squares (LS) mean change in HbA1c from baseline was -1.12% (95% CI -1.24 to -1.01) and -1.23% (95% CI -1.34 to -1.11) with HS-IDegAsp and NN-IDegAsp, respectively. The LS mean difference (HS-IDegAsp minus NN-IDegAsp) at Week 24 was 0.10% (95% CI -0.06 to 0.27), demonstrating that HS-IDegAsp was non-inferior to NN-IDegAsp. There was no statistically significant difference (P > 0.05) in fasting plasma glucose or proportion of patients achieving HbA1c < 7.0% at Week 24 between both groups. Safety and immunogenicity were similar between both groups.
CONCLUSIONS: HS-IDegAsp demonstrated comparable efficacy and safety to NN-IDegAsp during the 24-week treatment period in Chinese patients with inadequately controlled T2DM previously treated on once- or twice-daily premixed or basal insulin, with or without OADs.