Hirotsu Takao, Taniguchi Kanta, Nishimura Rimei
Department of Diabetes, Endocrinology and Hematology, Fuji Municipal Central Hospital, Fuji, Japan.
Department of Internal Medicine, Taniguchi Medical Clinic, Fujinomiya, Japan.
Front Clin Diabetes Healthc. 2025 Mar 24;6:1520389. doi: 10.3389/fcdhc.2025.1520389. eCollection 2025.
Oral semaglutide is a glucagon-like peptide-1 receptor agonist (GLP-1 RA) approved for the treatment of type 2 diabetes mellitus (T2DM). Findings from randomized controlled trials (RCTs) and real-world studies indicate that oral semaglutide leads to significant improvements in HbA1c and body weight, comparable to those observed with injectable GLP-1 RAs. Consequently, oral semaglutide is expected to significantly reduce barriers to initiating GLP-1 RA therapy in individuals with diabetes and may lead to an increased transition from dipeptidyl peptidase-4 inhibitors (DPP-4is) to GLP-1 RA therapy. This study was conducted to prospectively investigate the clinical characteristics predicting the achievement of HbA1c < 7% (52 mmol/mol) in Japanese individuals with T2DM who switched from DPP-4is to oral semaglutide.
The study enrolled a total of 74 patients who switched from DPP-4is to oral semaglutide between December 2021 and October 2022, with the dose being uptitrated to achieve HbA1c < 7% (52 mmol/mol) in these patients.
The study included a total of 44 individuals who achieved the target with oral semaglutide 3 mg (n=7), 7 mg (n=24), or 14 mg (n=13), and 17 individuals who did not (un-achieved group; n=17), based on their clinical characteristics and hematological findings. In the comparison between the Un-achieved group and the Achieved (3 to 14 mg) group, the proportions of "Current alcohol drinking ( = 0.030)" and "Current alcohol drinking and smoking ( = 0.029)" were higher in the Un-achieved group, whereas the proportion of "Taking 31 minutes or longer to have breakfast after drug administration ( = 0.022)" was higher in the Achieved (3 to 14 mg) group. A logistic regression analysis using the stepwise method identified "No current history of both smoking and alcohol drinking (0.083[0.014-0.485]; 0.006)" and "Taking 31 minutes or longer to eat breakfast after drug administration (0.117[0.029-0.480]; 0.003)" as factors predicting the achievement of the HbA1c < 7% (52 mmol/mol).
Study findings suggest when considering switching T2D patients from DPP-4is to oral semaglutide, a detailed assessment of "current alcohol drinking and smoking status" and "the duration between the administration of oral semaglutide and breakfast" may be useful as a predictive indicator for achieving HbA1c < 7% (52 mmol/mol).
口服司美格鲁肽是一种胰高血糖素样肽-1受体激动剂（GLP-1 RA），已被批准用于治疗2型糖尿病（T2DM）。随机对照试验（RCT）和真实世界研究的结果表明，口服司美格鲁肽可使糖化血红蛋白（HbA1c）和体重显著改善，与注射用GLP-1 RA的效果相当。因此，口服司美格鲁肽有望显著降低糖尿病患者启动GLP-1 RA治疗的障碍，并可能导致从二肽基肽酶-4抑制剂（DPP-4i）向GLP-1 RA治疗的转换增加。本研究旨在前瞻性调查从DPP-4i转换为口服司美格鲁肽的日本T2DM患者中，预测HbA1c<7%（52 mmol/mol）达标的临床特征。
该研究共纳入74例在2021年12月至2022年10月期间从DPP-4i转换为口服司美格鲁肽的患者，并上调剂量以使这些患者的HbA1c<7%（52 mmol/mol）。
根据临床特征和血液学检查结果，该研究共纳入44例通过口服3 mg（n=7）、7 mg（n=24）或14 mg（n=13）司美格鲁肽达到目标的患者，以及17例未达到目标的患者（未达标组；n=17）。在未达标组与达标（3至14 mg）组的比较中，未达标组中“当前饮酒（P=0.030）”和 “当前饮酒且吸烟（P=0.029）” 的比例较高，而达标（3至14 mg）组中 “给药后吃早餐时间为31分钟或更长（P=0.022）” 的比例较高。使用逐步法进行的逻辑回归分析确定，“目前无吸烟和饮酒史（0.083[0.014 - 0.485]；P=0.006）” 和 “给药后吃早餐时间为31分钟或更长（0.1l7[0.029 - 0.480]；P=0.003）” 是预测HbA1c<7%（52 mmol/mol）达标的因素。
研究结果表明，在考虑将T2D患者从DPP-4i转换为口服司美格鲁肽时，详细评估 “当前饮酒和吸烟状况” 以及 “口服司美格鲁肽与早餐之间的间隔时间” 可能有助于作为预测HbA1c<7%（52 mmol/mol）达标的指标。
