Ohara Makoto, Yokoyama Hiroki, Seino Hiroaki, Fujikawa Tomoki, Kohata Yo, Takahashi Noriyuki, Irie Shunichiro, Terasaki Michishige, Mori Yusaku, Fukui Tomoyasu, Yamagishi Sho-Ichi
Division of Diabetes, Metabolism, and Endocrinology, Department of Medicine, Showa University Graduate School of Medicine, 1-5-8 Hatanodai, Shinagawa-Ku, Tokyo, Japan.
Department of Internal Medicine, Jiyugaoka Medical Clinic, Obihiro, Japan.
Diabetol Metab Syndr. 2025 Apr 15;17(1):126. doi: 10.1186/s13098-025-01691-y.
To compare the effects of switching from dipeptidyl peptidase 4 (DPP-4) inhibitors to oral semaglutide on oxidative stress and glucose variability assessed by continuous glucose monitoring in patients with type 2 diabetes mellitus (T2DM).
This was an open-label, prospective, randomized, multicenter, parallel-group comparison study conducted over 24 weeks. Patients with T2DM who had been taking regular doses of DPP-4 inhibitors for at least 12 weeks were enrolled. They were randomly assigned to either continue on DPP-4 inhibitors (DPP-4 inhibitor group) or switch to oral semaglutide at 3 mg/day, with a dose increase to 7 mg/day after 4 weeks (semaglutide group). The primary endpoint was the change in the diacron-reactive oxygen metabolites test, an oxidative stress marker. Secondary endpoints included changes in glucose variability assessed using continuous glucose monitoring, metabolic indices, physical assessments, and Diabetes Treatment Satisfaction Questionnaire scores.
Fifty-eight patients with T2DM were randomized to the semaglutide group (n = 30) and the DPP-4 inhibitor group (n = 28). Six patients in the semaglutide group and one patient in the DPP-4 inhibitor group dropped out during the study. Ultimately, data from 24 patients in the semaglutide group and 27 patients in the DPP-4 inhibitor group were included for analysis. Switching to oral semaglutide therapy for 24 weeks significantly reduced oxidative stress, glucose variability, and hemoglobin A1c levels compared to continuous treatment with DPP-4 inhibitors. However, there was no significant difference in Diabetes Treatment Satisfaction Questionnaire scores between the two groups.
(II) CONCLUSIONS: Our study demonstrated that switching to oral semaglutide therapy from DPP-4 inhibitors significantly improved oxidative stress and glycemic parameters, including glucose variability, in patients with T2DM.
jRCT1031210620.
比较2型糖尿病（T2DM）患者从二肽基肽酶4（DPP-4）抑制剂转换为口服司美格鲁肽对通过连续血糖监测评估的氧化应激和血糖变异性的影响。
这是一项为期24周的开放标签、前瞻性、随机、多中心、平行组比较研究。纳入了至少服用常规剂量DPP-4抑制剂12周的T2DM患者。他们被随机分配继续使用DPP-4抑制剂（DPP-4抑制剂组）或换用口服司美格鲁肽，起始剂量为3毫克/天，4周后剂量增加至7毫克/天（司美格鲁肽组）。主要终点是氧化应激标志物——戴克隆反应性氧代谢产物检测的变化。次要终点包括使用连续血糖监测评估的血糖变异性变化、代谢指标、身体评估以及糖尿病治疗满意度问卷得分的变化。
58例T2DM患者被随机分为司美格鲁肽组（n = 30）和DPP-4抑制剂组（n = 28）。司美格鲁肽组有6例患者和DPP-4抑制剂组有1例患者在研究期间退出。最终，纳入了司美格鲁肽组24例患者和DPP-4抑制剂组27例患者的数据进行分析。与继续使用DPP-4抑制剂治疗相比，换用口服司美格鲁肽治疗24周可显著降低氧化应激、血糖变异性和糖化血红蛋白水平。然而，两组之间的糖尿病治疗满意度问卷得分没有显著差异。
（二）结论：我们的研究表明，从DPP-4抑制剂转换为口服司美格鲁肽治疗可显著改善T2DM患者的氧化应激和血糖参数，包括血糖变异性。
jRCT1031210620。
