He Qinghua, Cheng Zhifeng, Li Yufeng, Xing Xiaoyan, Li Liping, Li Xinsheng, Zhang Junqing, Xu Lingling, Song Weihong, Li Fangqiong, Zhang Zhanhui, Guo Lixin
Department of Endocrinology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, China.
Department of Endocrinology, The Fourth Affiliated Hospital of Harbin Medical University, Harbin, China.
Diabetes Obes Metab. 2025 Feb;27(2):965-975. doi: 10.1111/dom.16096. Epub 2024 Dec 4.
To assess the efficacy and safety of cofrogliptin for impaired glucose tolerance (IGT).
In this multicenter, double-blind, placebo-controlled phase 2 trial, IGT patients were randomized 1:1:1 to receive cofrogliptin 10 mg, cofrogliptin 25 mg or placebo once biweekly. The primary endpoint was the change from baseline in glucose total AUC during meal tolerance test (MTT) at week 12.
Among 261 subjects screened, 99 were enrolled. At week 12, significant mean reductions from baseline in glucose total AUC during MTT were observed in cofrogliptin groups (10 mg: -1.75 mmol h/L, p = 0.01; 25 mg: -1.54 mmol h/L, p = 0.02) versus placebo (0.36 mmol h/L). Significant benefits were also seen with cofrogliptin for secondary endpoints of the change from baseline in C of glucose during MTT 0-3 h at week 12, and the change from baseline in glucose total AUC and C of glucose during OGTT 0-3 h at week 10 versus placebo. Additionally, more cofrogliptin-treated patients achieved normoglycaemia versus placebo at week 10. The incidence of AEs was generally comparable in all groups, and all of AEs were mild or moderate. No serious AEs or severe hypoglycaemia were reported.
A 12-week treatment with cofrogliptin provided significant glucose-lowering, and was safe, well tolerated.
评估可孚列汀治疗糖耐量受损（IGT）的疗效和安全性。
在这项多中心、双盲、安慰剂对照的2期试验中，IGT患者按1:1:1随机分组，每两周接受一次10毫克可孚列汀、25毫克可孚列汀或安慰剂治疗。主要终点是第12周进餐耐量试验（MTT）期间葡萄糖总AUC相对于基线的变化。
在261名筛查受试者中，99名被纳入研究。在第12周时，可孚列汀组（10毫克：-1.75毫摩尔·小时/升，p = 0.01；25毫克：-1.54毫摩尔·小时/升，p = 0.02）的MTT期间葡萄糖总AUC相对于基线有显著的平均降低，而安慰剂组为0.36毫摩尔·小时/升。在第12周MTT 0至3小时期间葡萄糖C相对于基线的变化以及第10周口服葡萄糖耐量试验（OGTT）0至3小时期间葡萄糖总AUC和葡萄糖C相对于基线的变化这些次要终点方面，可孚列汀也显示出显著益处。此外，在第10周时，与安慰剂相比，更多接受可孚列汀治疗的患者实现了血糖正常。各治疗组不良事件（AE）的发生率总体相当，且所有AE均为轻度或中度。未报告严重AE或严重低血糖事件。
可孚列汀治疗12周可显著降低血糖，且安全性良好、耐受性佳。
