Real-World Use of Oral Semaglutide in Adults with Type 2 Diabetes: The PIONEER REAL Switzerland Multicentre, Prospective, Observational Study

Anastas Kick; Khadija M'Rabet-Bensalah; Flavio Acquistapace; Hanan Amadid; Robert A Ambühl; Uffe Christian Braae; Flurin Item; Bernd Schultes; Thomas Züger; Gottfried Rudofsky

doi:10.1007/s13300-023-01525-y

Real-World Use of Oral Semaglutide in Adults with Type 2 Diabetes: The PIONEER REAL Switzerland Multicentre, Prospective, Observational Study

Diabetes Ther. 2024 Mar;15(3):623-637. doi: 10.1007/s13300-023-01525-y. Epub 2024 Jan 19.

Authors

Affiliations

¹ Primary Care Group Practice Sanacare, Lugano, Switzerland.
² Novo Nordisk Pharma AG, Zurich, Switzerland.
³ SCA: Primary Care Cardiological Practice, Lugano, Switzerland.
⁴ Novo Nordisk A/S, Søborg, Denmark.
⁵ Primary Care Practice Schöngrund, Rotkreuz, Switzerland.
⁶ Metabolic Center St. Gallen, friendlyDocs AG, St. Gallen, Switzerland.
⁷ Department of Endocrinology, Diabetes and Metabolic Diseases, Cantonal Hospital of Olten, Olten, Switzerland.
⁸ Department of Endocrinology, Diabetes and Metabolic Diseases, Cantonal Hospital of Olten, Olten, Switzerland. gottfried.rudofsky@hin.ch.
⁹ Practice for Endocrinology, Diabetes and Obesity, Olten, Switzerland. gottfried.rudofsky@hin.ch.

Abstract

Introduction: Real-world data provide insight into how medications perform in clinical practice. The PIONEER REAL Switzerland study aimed to understand clinical outcomes with oral semaglutide in adults with type 2 diabetes (T2D).

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 (HbA_1c) 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 HbA_1c < 7.0% and the composite endpoints HbA_1c 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, HbA_1c 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 HbA_1c (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.

Conclusion: People living with T2D treated with oral semaglutide in Switzerland achieved clinically significant reductions in HbA_1c and BW, with no new safety signals.

Clinical trial registration: ClinicalTrials.gov: NCT04537624. A graphical abstract is available for this article.

Keywords: GLP-1 receptor agonist; Glucose-lowering medication; Glycaemic control; Incretin therapy; Real-world evidence; Semaglutide; Type 2 diabetes.

Associated data

ClinicalTrials.gov/NCT04537624