Abstract：
BACKGROUND: In this phase 4, multicentre, prospective, non-interventional PIONEER REAL Netherlands study, we assessed clinical outcomes associated with once-daily oral semaglutide use in real-world clinical practice in adults living with type 2 diabetes (T2D) naïve to injectable glucose-lowering medication.
METHODS: Participants initiated on oral semaglutide were followed for 34-44 weeks. Change in glycated haemoglobin (HbA1c) from baseline (BL) to end of study (EOS) was the primary endpoint; secondary endpoints included change in body weight (BW) from BL to EOS, the proportion of participants with HbA1c < 7.0% at EOS and the composite endpoints of HbA1c reduction ≥ 1.0%-points with BW reduction ≥ 3% or ≥ 5% at EOS. Treatment satisfaction was assessed using the Diabetes Treatment Satisfaction Questionnaire (DTSQ status/change). Safety was evaluated in all participants who initiated oral semaglutide treatment.
RESULTS: Oral semaglutide was initiated in 187 participants; 94.1% completed the study and 78.6% remained on treatment at EOS. At BL, 54.0% of participants were male, mean age was 58.8 years, mean duration of T2D was 8.7 years and mean body mass index was 35.1 kg/m2; mean HbA1c was 8.6% and mean BW was 103.1 kg. Significant improvements from BL to EOS were observed for HbA1c and BW (estimated change [95% confidence interval]: - 1.16%-points [- 1.48 to - 0.85]; p < 0.0001, and - 5.84 kg [- 6.88 to - 4.80]; p < 0.0001, respectively). At EOS, 47.5% of participants had an HbA1c level < 7.0%; 41.8% and 35.5% of participants achieved composite endpoints of HbA1c reduction ≥ 1.0%-points plus BW reduction ≥ 3% or ≥ 5%, respectively. DTSQ status and change scores improved by 2.1 (p = 0.0003) and 10.8 points (p < 0.0001), respectively. Oral semaglutide was easy or very easy to consume for 81.5% of participants. Adverse events were mostly mild/moderate, with gastrointestinal disorders being the most common.
CONCLUSIONS: In this real-world population, we reported clinically significant reductions in HbA1c and BW, improved treatment satisfaction and no new safety concerns. A graphical abstract is available with this article.
BACKGROUND: NCT04601740.
METHODS: Participants initiated on oral semaglutide were followed for 34-44 weeks. Change in glycated haemoglobin (HbA1c) from baseline (BL) to end of study (EOS) was the primary endpoint; secondary endpoints included change in body weight (BW) from BL to EOS, the proportion of participants with HbA1c < 7.0% at EOS and the composite endpoints of HbA1c reduction ≥ 1.0%-points with BW reduction ≥ 3% or ≥ 5% at EOS. Treatment satisfaction was assessed using the Diabetes Treatment Satisfaction Questionnaire (DTSQ status/change). Safety was evaluated in all participants who initiated oral semaglutide treatment.
RESULTS: Oral semaglutide was initiated in 187 participants; 94.1% completed the study and 78.6% remained on treatment at EOS. At BL, 54.0% of participants were male, mean age was 58.8 years, mean duration of T2D was 8.7 years and mean body mass index was 35.1 kg/m2; mean HbA1c was 8.6% and mean BW was 103.1 kg. Significant improvements from BL to EOS were observed for HbA1c and BW (estimated change [95% confidence interval]: - 1.16%-points [- 1.48 to - 0.85]; p < 0.0001, and - 5.84 kg [- 6.88 to - 4.80]; p < 0.0001, respectively). At EOS, 47.5% of participants had an HbA1c level < 7.0%; 41.8% and 35.5% of participants achieved composite endpoints of HbA1c reduction ≥ 1.0%-points plus BW reduction ≥ 3% or ≥ 5%, respectively. DTSQ status and change scores improved by 2.1 (p = 0.0003) and 10.8 points (p < 0.0001), respectively. Oral semaglutide was easy or very easy to consume for 81.5% of participants. Adverse events were mostly mild/moderate, with gastrointestinal disorders being the most common.
CONCLUSIONS: In this real-world population, we reported clinically significant reductions in HbA1c and BW, improved treatment satisfaction and no new safety concerns. A graphical abstract is available with this article.
BACKGROUND: NCT04601740.
摘要：
背景：在此阶段4中，多中心，prospective,非介入性先驱真正的荷兰研究，我们评估了2型糖尿病(T2D)成人患者在实际临床实践中每天口服一次司美鲁肽与注射降糖药物相关的临床结局.
方法：开始口服司马鲁肽的参与者随访34-44周。糖化血红蛋白（HbA1c）从基线（BL）到研究结束（EOS）的变化是主要终点；次要终点包括体重（BW）从BL到EOS的变化，EOS时HbA1c<7.0%的参与者比例和EOS时HbA1c降低≥1.0%的复合终点，BW降低≥3%或≥5%。使用糖尿病治疗满意度问卷（DTSQ状态/变化）评估治疗满意度。对所有开始口服司马鲁肽治疗的参与者进行安全性评估。
结果：187名参与者开始口服司马鲁肽；94.1%完成研究，78.6%仍在EOS治疗。在BL,54.0%的参与者是男性，平均年龄58.8岁,T2D的平均持续时间为8.7年,平均体重指数为35.1kg/m2;平均HbA1c为8.6%,平均体重为103.1kg.HbA1c和BW观察到从BL到EOS的显着改善（估计变化[95％置信区间]：-1.16％点[-1.48至-0.85]；p<0.0001和-5.84kg[-6.88至-4.80]；p<0.0001）。在EOS,47.5%的参与者的HbA1c水平<7.0%;41.8%和35.5%的参与者实现了HbA1c降低≥1.0%的复合终点，加上BW降低≥3%或≥5%，分别。DTSQ状态和变化分数分别提高了2.1分（p=0.0003）和10.8分（p<0.0001），分别。81.5%的参与者口服司马鲁肽很容易或非常容易食用。不良事件大多为轻度/中度，胃肠功能紊乱是最常见的。
结论：在现实世界中，我们报道了HbA1c和BW的临床显着降低，提高了治疗满意度，没有新的安全问题。本文提供了图形摘要。
背景：NCT04601740。
方法：开始口服司马鲁肽的参与者随访34-44周。糖化血红蛋白（HbA1c）从基线（BL）到研究结束（EOS）的变化是主要终点；次要终点包括体重（BW）从BL到EOS的变化，EOS时HbA1c<7.0%的参与者比例和EOS时HbA1c降低≥1.0%的复合终点，BW降低≥3%或≥5%。使用糖尿病治疗满意度问卷（DTSQ状态/变化）评估治疗满意度。对所有开始口服司马鲁肽治疗的参与者进行安全性评估。
结果：187名参与者开始口服司马鲁肽；94.1%完成研究，78.6%仍在EOS治疗。在BL,54.0%的参与者是男性，平均年龄58.8岁,T2D的平均持续时间为8.7年,平均体重指数为35.1kg/m2;平均HbA1c为8.6%,平均体重为103.1kg.HbA1c和BW观察到从BL到EOS的显着改善（估计变化[95％置信区间]：-1.16％点[-1.48至-0.85]；p<0.0001和-5.84kg[-6.88至-4.80]；p<0.0001）。在EOS,47.5%的参与者的HbA1c水平<7.0%;41.8%和35.5%的参与者实现了HbA1c降低≥1.0%的复合终点，加上BW降低≥3%或≥5%，分别。DTSQ状态和变化分数分别提高了2.1分（p=0.0003）和10.8分（p<0.0001），分别。81.5%的参与者口服司马鲁肽很容易或非常容易食用。不良事件大多为轻度/中度，胃肠功能紊乱是最常见的。
结论：在现实世界中，我们报道了HbA1c和BW的临床显着降低，提高了治疗满意度，没有新的安全问题。本文提供了图形摘要。
背景：NCT04601740。
