• Mingtong Xu, Kan Sun, Wenjie Xu, Chuan Wang, Dewen Yan, Shu Li, Li Cong, Yinzhen Pi, Weihong Song, Qingyuan Sun, Rijun Xiao, Weixia Peng, Jianping Wang, Hui Peng, Yawei Zhang, Peng Duan, Meiying Zhang, Jianying Liu, Qingmei Huang, Xuefeng Li, Yan Bao, Tianshu Zeng, Kun Wang, Li Qin, Chaoming Wu, Chunying Deng, Chenghu Huang, Shuang Yan, Wei Zhang, Meizi Li, Li Sun, Yanjun Wang, HongMei Li, Guang Wang, Shuguang Pang, Xianling Zheng, Haifang Wang, Fujun Wang, Xiuhai Su, Yujin Ma, Ziling Li, Zuoling Xie, Ning Xu, Lin Ni, Li Zhang, Xiangqun Deng, Tianrong Pan, Qijuan Dong, Xiaohong Wu, Xingping Shen, Xin Zhang, Qijing Zou, Chengxia Jiang, Jue Xi, Jianhua Ma, Jingchao Sun, and Li Yan.
• Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China.
• Bmc Med. 2023 Oct 9; 21 (1): 388388.

BackgroundDipeptidyl peptidase-4 inhibitors (DPP-4i) have become firmly established in treatment algorithms and national guidelines for improving glycemic control in type 2 diabetes mellitus (T2DM).To report the findings from a multicenter, randomized, double-blind, placebo-controlled phase 3 clinical trial, which was designed to assess the efficacy and safety of a novel DPP-4 inhibitor fotagliptin in treatment-naive patients with T2DM.MethodsPatients with T2DM were randomized to receive fotagliptin (n = 230), alogliptin (n = 113) or placebo (n = 115) at a 2:1:1 ratio for 24 weeks of double-blind treatment period, followed by an open-label treatment period, making up a total of 52 weeks. The primary efficacy endpoint was to determine the superiority of fotagliptin over placebo in the change of HbA1c from baseline to Week 24. All serious or significant adverse events were recorded.ResultsAfter 24 weeks, mean decreases in HbA1c from baseline were -0.70% for fotagliptin, -0.72% for alogliptin and -0.26% for placebo. Estimated mean treatment differences in HbA1c were -0.44% (95% confidence interval [CI]: -0.62% to -0.27%) for fotagliptin versus placebo, and -0.46% (95% CI: -0.67% to -0.26%) for alogliptin versus placebo, and 0.02% (95%CI: -0.16% to 0.19%; upper limit of 95%CI < margin of 0.4%) for fotagliptin versus alogliptin. So fotagliptin was non-inferior to alogliptin. Compared with subjects with placebo (15.5%), significantly more patients with fotagliptin (37.0%) and alogliptin (35.5%) achieved HbA1c < 7.0% after 24 weeks of treatment. During the whole 52 weeks of treatment, the overall incidence of hypoglycemia was low for both of the fotagliptin and alogliptin groups (1.0% each). No drug-related serious adverse events were observed in any treatment group.ConclusionsIn summary, the study demonstrated improvement in glycemic control and a favorable safety profile for fotagliptin in treatment-naive patients with T2DM.Trial RegistrationClinicalTrail.gov NCT05782192.© 2023. BioMed Central Ltd., part of Springer Nature.

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