编者按:岁启新篇,备受期待的《中国糖尿病防治指南(2024版)》正式线上发布。新版指南在多个方面进行了重要的更新和细化,为糖尿病的防治工作提供了全面的指导意见。尤为瞩目的是,2024版指南[1]首次将基础胰岛素/GLP-1RA固定比例复方制剂(FRC)纳入诊疗路径推荐。凭借扎实的循证证据,FRC跃居T2DM高血糖治疗路径的二联推荐,同时荣登口服药控制不佳T2DM患者胰岛素治疗的起始优选。
开创新篇
甘精利司在内的FRC首次纳入诊疗路径推荐
跃居二联推荐
甘精利司强效控糖、循证扎实
FRC跃居高血糖治疗二联推荐

图1. T2DM高血糖治疗的简易路径
•
LixiLan-O-AP[5]研究纳入以中国人群为主的亚太地区成人受试者,经口服降糖药(OADs)治疗血糖控制不佳添加甘精利司治疗,HbA1c降幅高达1.9%,HbA1c达标率近80%,显著优于添加甘精胰岛素或利司那肽治疗组,且甘精利司胃肠道不良反应发生率低于添加利司那肽治疗组。
•
SoliD磐石研究[6]完全纳入口服降糖药血糖控制不佳的中国 T2DM患者,与德谷门冬相比,甘精利司自基线至24周的HbA1c降幅达到了非劣效与优效,两组差值-0.2%,具有统计学意义。

荣登起始优选
SoliD磐石研究以OAD控制不佳患者为证
FRC荣登胰岛素治疗起始优选

该推荐背后,指南特别引用了SoliD磐石研究作为循证依据。该研究[9]显示,
•
在OADs控制不佳的中国患者中,在FPG降幅相当的情况下,甘精利司三餐后平均血糖较德谷门冬进一步下降25%;
•
此外,甘精利司较德谷门冬总体低血糖事件率减少29%,并实现-1.5 kg的体重获益。
此外,指南对FRC的具体用法作出说明,对于甘精利司的起始剂量应基于患者所需甘精胰岛素的剂量进行选择,并根据空腹血糖水平进行剂量调整直至达标,日最大剂量以不超过其中利司那肽的最大推荐剂量(20 μg/d)等。
结语
新年新气象,糖尿病领域也换新颜。时隔四年,2024版指南突破性地将基础胰岛素/GLP-1RA固定比例复方制剂(FRC)纳入T2DM诊疗路径。与旧版指南相比,FRC首次成为二联治疗及胰岛素治疗的起始优选。其中,甘精利司更是被证实具有强效的血糖控制效果,并在不同患者群体中均展示出显著疗效和安全性。特别是SoliD磐石研究显示,在口服降糖药血糖控制不佳的中国T2DM患者中,甘精利司在降糖疗效、低血糖风险及体重控制上均优势显著,为T2DM治疗开启了新篇章。
参考文献:
[1]中华医学会糖尿病学分会.中国糖尿病防治指南(2024版)[J].中华糖尿病杂志,2025 年1 月第 17 卷第 1 期.https://rs.yiigle.com/cmaid/1525739#F2
[2]中华医学会糖尿病学分会. 中国2型糖尿病防治指南(2020年版). 中华糖尿病杂志,2021,13(04):315-409. DOI:10.3760/cma.j.cn115791-20210221-00095
[3]American Diabetes Association Professional Practice Committee; 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes—2025. Diabetes Care 1 January 2025; 48 (Supplement_1): S181–S206. https://doi.org/10.2337/dc25-S009
[4]Davies MJ, Aroda VR, Collins BS, et al. Management of Hyperglycemia in Type 2 Diabetes, 2022. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2022 Nov 1;45(11):2753-2786. doi: 10.2337/dci22-0034. PMID: 36148880; PMCID: PMC10008140.
[5]Yang W, Dong X, Li Q, et al. Efficacy and safety benefits of iGlarLixi versus insulin glargine 100 U/mL or lixisenatide in Asian Pacific people with suboptimally controlled type 2 diabetes on oral agents: The LixiLan-O-AP randomized controlled trial. Diabetes Obes Metab. 2022 Aug;24(8):1522-1533. doi: 10.1111/dom.14722. Epub 2022 May 12. PMID: 35441412.
[6]]Liu M, Gu W, Chen L, et al. The efficacy and safety of iGlarLixi versus IDegAsp in Chinese people with type 2 diabetes suboptimally controlled with oral antidiabetic drugs: The Soli-D randomized controlled trial. Diabetes Obes Metab. 2024 Sep;26(9):3791-3800. doi: 10.1111/dom.15724. Epub 2024 Jun 22. PMID: 38922731.
[7]Aroda VR, Rosenstock J, Wysham C, et al. Efficacy and Safety of LixiLan, a Titratable Fixed-Ratio Combination of Insulin Glargine Plus Lixisenatide in Type 2 Diabetes Inadequately Controlled on Basal Insulin and Metformin: The LixiLan-L Randomized Trial. Diabetes Care. 2016 Nov;39(11):1972-1980. doi: 10.2337/dc16-1495. Epub 2016 Sep 20. Erratum in: Diabetes Care. 2017 Jun;40(6):809. doi: 10.2337/dc17-er06d. PMID: 27650977.
[8]Yuan X, Guo X, Zhang J, et al. Improved glycaemic control and weight benefit with iGlarLixi versus insulin glargine 100 U/mL in Chinese people with type 2 diabetes advancing their therapy from basal insulin plus oral antihyperglycaemic drugs: Results from the LixiLan-L-CN randomized controlled trial. Diabetes Obes Metab. 2022 Nov;24(11):2182-2191. doi: 10.1111/dom.14803. Epub 2022 Jul 25. PMID: 35762489; PMCID: PMC9795930.
[9]Blonde L, Rosenstock J, Del Prato S, et al. Switching to iGlarLixi Versus Continuing Daily or Weekly GLP-1 RA in Type 2 Diabetes Inadequately Controlled by GLP-1 RA and Oral Antihyperglycemic Therapy: The LixiLan-G Randomized Clinical Trial. Diabetes Care. 2019 Nov;42(11):2108-2116. doi: 10.2337/dc19-1357. Epub 2019 Sep 17. PMID: 31530665.
[10]Rosenstock J, Emral R, Sauque-Reyna L, et al. Advancing Therapy in Suboptimally Controlled Basal Insulin-Treated Type 2 Diabetes: Clinical Outcomes With iGlarLixi Versus Premix BIAsp 30 in the SoliMix Randomized Controlled Trial. Diabetes Care. 2021 Jun 28;44(10):2361–70. doi: 10.2337/dc21-0393. Epub ahead of print. PMID: 34183429; PMCID: PMC8740944.
[11]Soli-switch: efficacy and safety of switching to iGlarLixi from premixed insulins in people with type 2 diabetes.EASD 2024: 791.
[12]1.国家老年医学中心,中华医学会老年医学分会,中国老年保健协会糖尿病专业委员会.中国老年糖尿病诊疗指南(2024版)[J].中华糖尿病杂志, 2024, 16(02):147-189. DOI:10.3760/cma.j.cn115791-20240112-00020.
发布留言