Efficacy and safety of insulin degludec biosimilar B01411 versus originator insulin degludec in Chinese patients with type 2 diabetes inadequately controlled on oral antidiabetic drugs: a multicenter, randomized, open-label, phase 3 study.

IF 2.4 4区 医学 Q1 MEDICINE, GENERAL & INTERNAL Current Medical Research and Opinion Pub Date : 2024-10-01 Epub Date: 2024-09-18 DOI:10.1080/03007995.2024.2401096
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
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Abstract

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. The primary endpoint was the change from baseline in glycated hemoglobin (HbA1c) to week 18.

Results: At week 18, the least squares (LS) mean change in HbA1c from baseline was -1.34% (95% CI -1.47 to -1.21) and -1.25% (95% CI -1.38 to -1.12) with HS-IDeg and NN-IDeg, respectively. The LS mean difference (HS-IDeg minus NN-IDeg) in HbA1c at week 18 was -0.09% (95% CI -0.28 to 0.10), demonstrating non-inferiority of HS-IDeg to NN-IDeg. Participants achieving HbA1c <7.0% at week 18 were 34.5% and 29.5% with HS-IDeg and NN-IDeg, respectively. Mean decreases in fasting plasma glucose and standard deviation of blood glucose were similar between both groups. Safety and tolerability, including hypoglycemia, adverse events, and weight change were similar between both groups. No severe hypoglycemia and no death occurred in the study.

Conclusions: HS-IDeg and NN-IDeg demonstrated similar efficacy and safety over 18 weeks of treatment in Chinese patients with T2DM who had inadequate responses to OADs for at least 3 months.

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在口服抗糖尿病药物控制不佳的中国 2 型糖尿病患者中,德鲁达胰岛素生物仿制药 B01411 与原研药德鲁达胰岛素的疗效和安全性:一项多中心、随机、开放标签的 3 期研究。
目的比较德谷胰岛素生物仿制药B01411(HS-IDeg)与原研药德谷胰岛素-特瑞沙(NN-IDeg)对口服抗糖尿病药物(OADs)至少3个月仍未得到充分控制的中国2型糖尿病(T2DM)患者的疗效和安全性:这项多中心、随机、开放标签、平行分组、主动对照的三期研究共招募了362名T2DM患者。根据筛查前是否使用过胰岛素促泌剂(磺脲类或格列奈类)对参与者进行分层,然后按1:1的比例随机分组,接受每日一次的HS-IDeg(180人)或NN-IDeg(182人)皮下注射,为期18周。主要终点是糖化血红蛋白(HbA1c)从基线到第18周的变化:第 18 周时,HS-IDeg 和 NN-IDeg 的 HbA1c 与基线相比的最小二乘法(LS)平均变化率分别为-1.34%(95% CI -1.47 至-1.21)和-1.25%(95% CI -1.38 至-1.12)。第18周时,HbA1c的LS平均差异(HS-IDeg减去NN-IDeg)为-0.09%(95% CI -0.28至0.10),表明HS-IDeg不劣于NN-IDeg:HS-IDeg和NN-IDeg在治疗至少3个月OAD反应不充分的中国T2DM患者18周的疗效和安全性相似。
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来源期刊
Current Medical Research and Opinion
Current Medical Research and Opinion 医学-医学:内科
CiteScore
4.40
自引率
4.30%
发文量
247
审稿时长
3-8 weeks
期刊介绍: Current Medical Research and Opinion is a MEDLINE-indexed, peer-reviewed, international journal for the rapid publication of original research on new and existing drugs and therapies, Phase II-IV studies, and post-marketing investigations. Equivalence, safety and efficacy/effectiveness studies are especially encouraged. Preclinical, Phase I, pharmacoeconomic, outcomes and quality of life studies may also be considered if there is clear clinical relevance
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