PIONEER REAL Saudi Arabia: A multicentre, prospective, real-world study of once-daily oral semaglutide use in adults with type 2 diabetes in Saudi Arabia.

AIM: PIONEER REAL Saudi Arabia investigated real-world clinical outcomes associated with the use of once-daily oral semaglutide in adults with type 2 diabetes (T2D). MATERIALS AND METHODS: This was a 34- to 44-week multicentre, prospective, open-label study in adults with T2D, who were treatment-naive to injectable glucose-lowering medication and initiated oral semaglutide in routine clinical practice. The primary endpoint was change from baseline to end of study (EoS) in glycated haemoglobin (HbA1c). Secondary and exploratory endpoints included changes in body weight (BW) and waist circumference (WC) from baseline to EoS. Treatment satisfaction was assessed using the Diabetes Treatment Satisfaction Questionnaire-status (DTSQs) and change (DTSQc) tools. RESULTS: In total, 192 participants initiated oral semaglutide. At baseline, mean (standard deviation) age was 51.7 (10.91) years, mean HbA1c was 8.0% (1.51) and mean BW was 90.5 kg (15.68). In total, 139 participants completed the study. Estimated mean (standard error [SE]) changes (95% confidence interval) in HbA1c and BW were -1.0%-points (0.09; p < 0.0001) and -4.4 kg (0.51; p < 0.0001), respectively. Estimated mean (SE) change in WC was -4.3 cm (0.62; p < 0.0001). At EoS, 61.9% of participants had HbA1c levels <7%, with 21.9% and 17.1% achieving HbA1c reductions of ≥1% alongside BW reductions of ≥3% or ≥5%, respectively. Treatment satisfaction increased significantly (mean change in DTSQs +8.7 and DTSQc 14.9; both p < 0.0001). At EoS, 49.5% of participants remained on oral semaglutide, of whom 47.4% were receiving the 14.0 mg dose. CONCLUSIONS: This real-world population of adults with T2D in Saudi Arabia experienced clinically significant reductions in HbA1c and BW, increased treatment satisfaction and a favourable safety profile, consistent with previously published PIONEER REAL studies.