欧盟委员会批准诺和诺德基础胰岛素周制剂依柯胰岛素与GLP-1RA周制剂司美格鲁肽的联合制剂Kyinsu上市_医药

2025

11/26

12:50

医谷网医药

近日，诺和诺德宣布，欧盟委员会（EC）已批准其Kyinsu（每周一次IcoSema，基础胰岛素周制剂依柯胰岛素与GLP-1RA周制剂司美格鲁肽的联合制剂）的上市许可。该药适用于接受基础胰岛素或GLP-1受体激动剂治疗但血糖控制不佳的成人2型糖尿病患者，作为饮食和运动的辅助手段，与口服降糖药物联用。

目前，全球约有5.89亿成人糖尿病患者，其中超过90%为2型糖尿病[4]。胰岛素仍是2型糖尿病治疗的基石[5][6]；然而，高达50%需要胰岛素治疗的2型患者会延迟起始治疗超过两年，这可能增加糖尿病并发症风险[7]-[10]。即便开始胰岛素治疗后，多数患者的病情仍未得到充分控制 [11]。对体重增加、低血糖以及治疗复杂性的担忧，常是延迟起始或强化胰岛素治疗的关键因素[12][13]。

欧盟委员会的批准基于COMBINE 3a期临床试验项目的积极结果。该临床试验项目共涉及超过2,500名成人2型糖尿病患者，在所有三项试验中均达到主要终点，证明每周一次IcoSema在降低血糖（通过HbA1c变化衡量）方面优效于其单组分[1][2]，并且与每日基础-餐时胰岛素方案相比血糖降低具有非劣效性[3]。此外，IcoSema显示出更显著的体重减轻*[1][3] 以及较低的低血糖（有临床意义的或严重的低血糖）发生率**[1]-[3]。在整个3a期临床试验项目中，每周一次IcoSema显示出安全且耐受性良好的特征[1]-[3]。

据悉，该上市许可适用于欧盟全部27个成员国以及冰岛、挪威和列支敦士登。此外，Kyinsu目前已在其他多个国家完成注册申报，预计在2026年内将获得更多监管决定。

参考文献

1. Mathieu C, Giorgino F, Kim SG, et al. Once‑weekly IcoSema versus once‑weekly insulin icodec in type 2 diabetes management (COMBINE 1): an open‑label, multicentre, treat‑to‑target, randomised, phase 3a trial. Lancet Diabetes Endocrinol. 2025;13(7):568–579.

2. Lingvay I, Benamar M, Chen L, et al. Once-weekly IcoSema versus once-weekly semaglutide in adults with type 2 diabetes: the COMBINE 2 randomised clinical trial. Diabetologia. 2025.

3. Billings LK, Andreozzi F, Frederiksen M, et al. Once-weekly IcoSema versus multiple daily insulin injections in type 2 diabetes management (COMBINE 3): an open-label, multicentre, treat-to-target, non-inferiority, randomised, phase 3a trial. Lancet Diabetes Endocrinol. 2025;13(7):556–567.

4. International Diabetes Federation. IDF Diabetes Atlas (11th edition). Available at: https://diabetesatlas.org/ Last accessed: November 2025.

5. Davies MJ, Aroda VR, Collins BS, et al. Management of hyperglycaemia in type 2 diabetes, 2022. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetologia. 2022;65(12):1925–1966.

6. American Diabetes Association. Standards of Care in Diabetes-2023 Abridged for Primary Care Providers. Clin Diabetes. 2022;41(1):4–31.

7. ACCISS study. Insulin users’perspective profile. Available at: https://haiweb.org/wp-content/uploads/2017/05/Insulin-Users-Perspective-Profile.pdf. Last accessed: November 2025.

8. Rubino A, McQuay LJ, Gough SC, et al. Delayed initiation of subcutaneous insulin therapy after failure of oral glucose-lowering agents in patients with Type 2 diabetes: a population-based analysis in the UK. Diabet Med. 2007;24(12):1412–1418.

9. Hosomura N, Malmasi S, Timerman D, et al. Decline of insulin therapy and delays in insulin initiation in people with uncontrolled diabetes mellitus. Diabet Med. 2017;34(11):1599–1602.

10. Gavin JR, Abaniel RM, Virdi NS. Therapeutic Inertia and Delays in Insulin Intensification in Type 2 Diabetes: A Literature Review. Diabetes Spectr. 2023;36(4):379-384.

11. Mocarski M, Yeaw J, Divino V, et al. Slow Titration and Delayed Intensification of Basal Insulin Among Patients with Type 2 Diabetes. J Manag Care Spec Pharm. 2018;24(4):390–400.

12. Carver C. Insulin treatment and the problem of weight gain in type 2 diabetes. Diabetes Educ. 2006;32(6):910-917.

13. Curtis B, Lage MJ. Glycemic control among patients with type 2 diabetes who initiate basal insulin: a retrospective cohort study. J Med Econ. 2014;17(1):21–31.

* 相较于基础胰岛素和每日基础-餐时胰岛素治疗方案带来的体重增加。

** 有临床意义的（2级）低血糖：经血糖仪确认的血糖水平低于<3.0 mmol/L (<54 mg/dL) ；严重低血糖（3级）：伴有严重认知功能障碍且需他人协助才能恢复的低血糖事件。

来源：医谷网

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