Ultra rapid lispro improves postprandial glucose control versus lispro in combination with insulin glargine/degludec in adults with type 2 diabetes:a prospective,randomized,double-blind,phase 3 trial
超速效赖脯胰岛素相比赖脯胰岛素能更好控制成人2型糖尿病患者的餐后血糖波动:一项前瞻性、随机化、双盲、3期研究
查看参考文献35篇
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文摘
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Ultra rapid lispro (URLi) is a novel formulation of insulin lispro designed to more closely match the physiological insulin response to a meal,with the aim of improving postprandial glucose (PPG) control.We conducted a multinational,multicenter,randomized,double-blind,treat-to-target,26-week,phase 3 trial to evaluate the efficacy and safety of URLi in adults with type 2 diabetes (T2D).After an 8-week lead-in period during which basal insulin glargine or degludec was optimized,adults with T2D were randomized (2:1) to prandial URLi (n = 395) or lispro (n = 200).The primary endpoint was non-inferiority of URLi versus lispro in glycated hemoglobin A1c (HbA_(1c)) change from baseline to week 26.Multiplicity-adjusted analyses were performed to assess the superiority of URLi in 1- and 2-h PPG excursions during a mixed-meal tolerance test (MMTT) and HbA_(1c) change at week 26.URLi showed non-inferiority for HbA_(1c) change at week 26 versus lispro (least-squares mean [LSM] difference,0.07%;95% confidence interval:-0.07,0.21).HbA_(1c) was reduced by 0.56% and 0.63% with URLi and lispro,respectively,with no significant treatment difference (P = 0.321).URLi provided superior PPG excursion control versus lispro at 1 h (LSM difference:-14.6 mg/dL,P <0.001) and 2 h (LSM difference:-21.8 mg/dL,P <0.001) as well as other time points (30-240 min) during the MMTT.Incremental area under the glucose curve during the MMTT was also significantly lower with URLi versus lispro.The safety profiles were generally similar between treatment groups.In conclusion,URLi was superior to lispro for PPG control,with noninferiority in HbA_(1c) improvement,in adults with T2D. |
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其他语种文摘
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超速效赖脯胰岛素(URLi)是一种新型的赖脯胰岛素制剂,旨在更好地改善餐后血糖控制.这是一项多国、多中心(中国、墨西哥和阿根廷3个国家的41个研究中心)、随机化、双盲、3期研究,旨在评估URLi相比赖脯胰岛素(优泌乐®[HL])在成人2型糖尿病患者中的有效性和安全性.患者随机接受26周的URLi(395名患者)或HL(200名患者)联合甘精胰岛素或德谷胰岛素治疗.主要研究终点为第26周HbAc相比基线变化的治疗间差异.第26周1和2 h餐后血糖波动(用餐开始后1 h和2 h测得的血糖分别减去空腹血糖)的治疗间差异为多重性调整终点.URLi和HL分别使HbA_(1c)较基线降低0.56%和0.63%,组间治疗差异无统计学意义.与HL相比较,URLi在控制第26周1 h和2h餐后血糖波动优效于HL,两组不良事件发生率相当.该研究表明在成人2型糖尿病患者中,基础-餐时给药方案中的URLi在控制HbA_(1c)方面非劣效于HL,而在控制餐后血糖波动方面显著优效于HL. |
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来源
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Science Bulletin
,2022,67(17):1785-1791 【核心库】
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DOI
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10.1016/j.scib.2022.08.002
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关键词
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Lispro
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Phase 3 trial
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Postprandial glucose control
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Type 2 diabetes
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Ultra rapid lispro
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地址
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1.
Department of Endocrinology and Metabolism,Shanghai Jiao Tong University School of Medicine Affiliated Sixth People's Hospital,Shanghai Diabetes Institute,Shanghai Clinical Center for Diabetes, Shanghai Key Laboratory of Diabetes Mellitus, Shanghai, 200233
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Lilly Suzhou Pharmaceutical Co.Ltd., Shanghai, 200041
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语种
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英文 |
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文献类型
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研究性论文 |
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ISSN
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2095-9273 |
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学科
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内科学 |
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文献收藏号
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CSCD:7354447
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