METHODS: PIONEER REAL Switzerland was a 34-44-week, multicentre, prospective, non-interventional, single-arm study of adults with T2D naïve to injectable glucose-lowering medication who were initiated on oral semaglutide in routine clinical practice. The primary endpoint was change in glycated haemoglobin (HbA1c) from baseline (BL) to end of study (EOS); secondary endpoints included change in body weight (BW) from BL to EOS and the proportion of participants achieving HbA1c < 7.0% and the composite endpoints HbA1c reduction ≥ 1%-points with BW reduction ≥ 3% or ≥ 5% at EOS. Safety was assessed in participants who received ≥ 1 dose of oral semaglutide.
RESULTS: Of the 185 participants (female/male, n = 67/118) initiating oral semaglutide, 168 (90.8%) completed the study and 143 (77.3%) remained on treatment with oral semaglutide at EOS. At BL, participants had a mean age of 62 years, diabetes duration of 6.4 years, HbA1c of 7.7%, BW of 95.6 kg and body mass index of 33.2 kg/m2; 56.2% of participants were receiving glucose-lowering medications. Significant reductions were observed for HbA1c (estimated change - 0.91%; 95% confidence interval [CI] - 1.10, - 0.71; p < 0.0001) and BW (estimated change - 4.85%; 95% CI - 5.70, - 4.00; p < 0.0001). In total, 139 adverse events (AEs) were reported in 65 (35.1%) participants; most were mild or moderate. The most frequent AEs were gastrointestinal disorders (27.0%); 31 AEs in 20 (10.8%) participants led to discontinuation of oral semaglutide. Six serious AEs were reported; all were considered unlikely to be related to oral semaglutide.
CONCLUSIONS: People living with T2D treated with oral semaglutide in Switzerland achieved clinically significant reductions in HbA1c and BW, with no new safety signals.
BACKGROUND: ClinicalTrials.gov: NCT04537624. A graphical abstract is available for this article.
方法:Pioneer真正的瑞士是一个34-44周,多中心,prospective,非干预性,在常规临床实践中开始口服司马鲁肽的T2D未接受可注射降糖药的成人的单臂研究。主要终点是糖化血红蛋白(HbA1c)从基线(BL)到研究结束(EOS)的变化;次要终点包括从BL到EOS的体重(BW)变化以及达到HbA1c<7.0%和复合终点HbA1c降低≥1%-点,BW降低≥3%或≥5%EOS。在接受≥1剂口服司马鲁肽的参与者中评估安全性。
结果:在185名参与者中(女性/男性,n=67/118)开始口服司马鲁肽,168人(90.8%)完成了研究,143人(77.3%)仍在EOS口服司马鲁肽治疗。在BL,参与者的平均年龄为62岁,糖尿病病程6.4年,HbA1c为7.7%,体重为95.6kg,体重指数为33.2kg/m2;56.2%的参与者正在接受降糖药物。HbA1c(估计变化-0.91%;95%置信区间[CI]-1.10,-0.71;p<0.0001)和BW(估计变化-4.85%;95%CI-5.70,-4.00;p<0.0001)显著下降。总的来说,65名(35.1%)参与者报告了139起不良事件(AE);大多数为轻度或中度。最常见的不良事件是胃肠道疾病(27.0%);20名(10.8%)参与者中的31种不良事件导致口服司马鲁肽停药。报告了6种严重的不良事件;所有不良事件均被认为不太可能与口服司马鲁肽有关。
结论:在瑞士口服司美鲁肽治疗的患有T2D的人在临床上实现了HbA1c和BW的显著降低,没有新的安全信号.
背景:ClinicalTrials.gov:NCT04537624。本文提供了图形摘要。