2021ADA热点|新一代基础胰岛素,『甘精胰岛素U300』多项重磅研究备受关注!

2021-07-01 ADA ADA

值得关注!

作为新一代基础胰岛素类似物,甘精胰岛素U300具有全新的皮下储库微沉淀技术,因此控糖疗效更持久、更平稳,在有效降糖的同时,其低血糖风险也较同类胰岛素更低;此外,甘精胰岛素U300的剂量调整更加灵活、患者满意度也更高。基于此,甘精胰岛素U300被国内外指南推荐为胰岛素治疗优选。本次ADA年会上,甘精胰岛素U300也不负众望,携多项大型研究惊艳亮相,这些研究将从以下三个方面出发进行深入探讨,精彩不容错过!

甘精胰岛素U300在真实世界中的疗效与安全性如何?

针对甘精胰岛素U300与胰高血糖素样肽-1受体激动剂(GLP-1RA)联合使用的研究—DELIVER-G研究结果将于本次年会上重磅发布。值得一提的是,DELIVER-G是第一项通过利用美国电子病历数据库(IBM Explorys)来评估GLP-1RA±口服降糖药治疗血糖控制不佳的T2DM患者,加用甘精胰岛素U300治疗效果的真实世界研究。

另外值得关注的是纳入多个国家地区糖尿病患者的ARTEMIS-DM研究,其覆盖范围包括亚洲的中国香港、印度、印度尼西亚、马来西亚、菲律宾、泰国,拉丁美洲的阿根廷、秘鲁、哥伦比亚,以及中东非洲的埃及、黎巴嫩、沙特阿拉伯、南非和土耳其。该研究旨在探讨在更广泛地域中,既往接受传统基础胰岛素治疗血糖控制不佳的成人2型糖尿病(T2DM)患者,应用甘精胰岛素U300治疗的疗效与安全性。

在更广泛的特殊人群中,甘精胰岛素U300的“真实”表现如何?

众所周知,BRIGHT研究亚组分析1,2探索了甘精胰岛素U300在老年或伴肾功能不全的T2DM患者中的疗效与安全性,并获得了喜人的结果。本次ADA年会上将要发布的ATOS研究的两项亚组分析,则旨在探讨在真实世界中,甘精胰岛素U300在老年(≥70岁)T2DM患者和T2DM合并肾功能不全患者中的有效性与安全性。

而另一项ATOS研究亚组分析则针对患者不同基线糖化血红蛋白(HbA1c)水平,对甘精胰岛素U300的疗效与低血糖风险进行了深入探索。

那么在1型糖尿病(T1DM)患者中,甘精胰岛素U300表现又如何呢?本次ADA年会上发布的一项研究将带来答案!该研究采用欧洲权威真实世界数据库进行研究设计,意在探讨甘精胰岛素U300在临床实践环境中治疗T1DM的疗效(甘精胰岛素U300已获EMA和FDA批准,可用于成人、6岁及以上儿童和青少年T1DM患者,以控制血糖水平)。

以上研究结果的发布相信将为甘精胰岛素U300在更广泛人群的应用,提供强有力的循证支持!

甘精胰岛素U300 VS. 其他基础胰岛素,孰更胜一筹?

RESTORE-1研究曾证实,在T1DM患者中,由第一代基础胰岛素(甘精胰岛素U100、地特胰岛素或NPH)转换为甘精胰岛素U300或德谷胰岛素U100治疗后,甘精胰岛素U300与德谷胰岛素U100相比,糖化血红蛋白(HbA1c)降幅相似,但是低血糖风险显著更低3。本次ADA年会上将要发布的RESTORE-2研究则旨在探讨在未接受过胰岛素治疗的T2DM患者中,起始甘精胰岛素U300与德谷胰岛素U100的疗效差异。孰胜孰劣,值得期待!

另一项利用美国Optum Clinformatics索赔数据库进行的大型回顾性真实世界研究意在探索从基础胰岛素(NPH、地特胰岛素、甘精胰岛素U100)转换为两组胰岛素(一组转换为甘精胰岛素U300,另一组转换为甘精胰岛素U100或地特胰岛素)治疗后的持久性、依从性、医疗资源利用及成本的差异。值得一提的是,一项中国多中心回顾性队列研究曾证实,低血糖事件的发生将显著增加患者就诊次数和治疗费用4,而此次ADA会上发布的这项研究相信将对进一步节省医疗成本起到一定的启示作用。

简言之,本次ADA年会上,有关甘精胰岛素U300的最新研究涵盖了糖尿病临床诊疗中关切的多方面内容,从更广泛地域的疗效探究到特殊人群的真实“表现”,从不同胰岛素治疗的差异挖掘再到真实世界的医疗成本探索,相信这场由甘精胰岛素U300带来的研究盛宴将让您“大饱眼福”!

参考文献:
Diabetes Obes Metab. 2021 Jul;23(7):1588-1593. doi: 10.1111/dom.14372. Epub 2021 Apr 1.
Haluzík M,et al. Diabetes Obes Metab. 2020 Aug;22(8):1369-1377. doi: 10.1111/dom.14043.
Laviola L, Porcellati F, Bruttomesso D. et al. Diabetes Ther. 2021 Feb;12(2):509-525.
Yue X,et al. Value Health Reg Issues. 2020 May;21:17-21.

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    2022-05-19 baoya
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    2021-06-25 般若傻瓜
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    2021-06-25 xxxx1054
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