Real-World Use of Oral Semaglutide in Adults with Type 2 Diabetes in the PIONEER REAL Netherlands Multicentre, Prospective, Observational Study.

Abstract

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. Participants initiated on oral semaglutide were followed for 34-44weeks. 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. 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 58.8years, mean duration of T2D was 8.7years and mean body mass index was 35.1kg/m2; mean HbA1c was 8.6% and mean BW was 103.1kg. 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-5.84kg [-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. 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. NCT04601740.