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每周注射一次胰岛素icodec治疗未使用过胰岛素的2型糖尿病患者
Once-Weekly Insulin for Type 2 Diabetes without Previous Insulin Treatment


Julio Rosenstock ... 糖尿病 • 2020.11.26
相关阅读
• 每周注射一次的在研基础胰岛素 • 2型糖尿病的药物治疗指南 • 2型糖尿病的血糖控制

胰岛素周制剂icodec 2期临床研究结果公布

——注射频次减少,治疗依从性提高

 

李晶,王广*

首都医科大学附属北京朝阳医院内分泌科

*通讯作者

 

众所周知,全球罹患2型糖尿病(T2DM)的人数激增1。为应对这些疾病负担,近年来多种控制血糖的新型口服药物问世,其中二肽基肽酶4抑制剂(DPP4i)、胰高血糖素样肽1(GLP-1)类似物及钠-葡萄糖协同转运蛋白2抑制剂(SGLT2i)等新型药物为控制T2DM及其并发症提供了有效手段。

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摘要


背景

目前认为降低基础胰岛素注射频率可能有助于提高2型糖尿病患者对胰岛素治疗的接受度和依从性。胰岛素icodec是一种被开发用于治疗糖尿病、可每周注射一次的基础胰岛素类似物。

 

方法

我们开展了一项为期26周的随机、双盲、双模拟、2期试验,本试验纳入未接受过胰岛素长期治疗,并且服用二甲双胍(联用或不联用二肽基肽酶4抑制剂)未能充分控制(糖化血红蛋白水平,7.0%~9.5%)的2型糖尿病患者,目的是比较每周注射一次胰岛素icodec与每日注射一次甘精胰岛素U100的疗效和安全性。主要终点是糖化血红蛋白水平从基线至第26周的变化。本试验还评估了安全性终点,包括低血糖发作和胰岛素相关不良事件。

 

结果

共计247例参与者(1∶1)被随机分配接受icodec或甘精胰岛素治疗。两组的基线特征相似,icodec组和甘精胰岛素组的平均基线糖化血红蛋白水平分别为8.09%和7.96%。第26周时,icodec组和甘精胰岛素组的糖化血红蛋白水平相对于基线的估计平均变化分别为-1.33个百分点和-1.15个百分点,两组的估计平均值分别达到6.69%和6.87%;相对于基线所发生变化的估计组间差异为-0.18个百分点(95% CI,-0.38~0.02,P=0.08)。本试验观察到的2级(血糖水平<54 mg/dL)或3级(重度认知损害)低血糖发生率低(icodec组,每患者年0.53起事件;甘精胰岛素组,每患者年0.46起事件;估计发生率比,1.09;95% CI,0.45~2.65)。在与胰岛素相关的关键不良事件方面,两组无差异,并且超敏反应和注射部位反应的发生率均较低。大多数不良事件为轻度,并且未发生与试验药物相关的严重事件。

 

结论

在2型糖尿病患者中,每周注射一次胰岛素icodec具有与每日注射一次甘精胰岛素相似的降糖效果和安全性(由诺和诺德公司资助,NN1436-4383在ClinicalTrials.gov注册号为NCT03751657)。 





作者信息

Julio Rosenstock, M.D., Harpreet S. Bajaj, M.D., M.P.H., Andrej Janež, M.D., Ph.D., Robert Silver, M.D., Kamilla Begtrup, M.Sc., Melissa V. Hansen, M.D., Ph.D., Ting Jia, M.D., Ph.D., and Ronald Goldenberg, M.D. for the NN1436-4383 Investigators*
From the Dallas Diabetes Research Center at Medical City, Dallas (J.R.); LMC Diabetes and Endocrinology, Brampton (H.S.B.), Leadership Sinai Centre for Diabetes, Mount Sinai Hospital, Toronto (H.S.B.), and LMC Diabetes and Endocrinology, Vaughan (R.G.) — all in Ontario, Canada; the Department of Endocrinology, Diabetes, and Metabolic Diseases, University Medical Center Ljubljana, Ljubljana, Slovenia (A.J.); Southern New Hampshire Diabetes and Endocrinology, Nashua (R.S.); and Novo Nordisk, Søborg, Denmark (K.B., M.V.H., T.J.). Address reprint requests to Dr. Rosenstock at juliorosenstock@dallasdiabetes.com. *A list of principal investigators in this trial is available in the Supplementary Appendix, available at NEJM.org.

 

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