Oral semaglutide use in type 2 diabetes : a pooled analysis of clinical and patient-reported outcomes from seven PIONEER REAL prospective real-world studies
Rudofsky, Gottfried Amadid, Hanan Braae, Uffe Christian Catrina, Sergiu-Bogdan Kick, Anastas Mandavya, Kabirdev Roslind, Klaus Saravanan, Ponnusamy van Houtum, William Jain, Akshay B.
Rudofsky, Gottfried
Amadid, Hanan
Braae, Uffe Christian
Catrina, Sergiu-Bogdan
Kick, Anastas
Mandavya, Kabirdev
Roslind, Klaus
Saravanan, Ponnusamy
van Houtum, William
Jain, Akshay B.
Affiliation
Private Practice for Endocrinology, Diabetes and Obesity, Olten, Switzerland; Novo Nordisk A/S, Søborg, Denmark; Karolinska Institute, Stockholm, Sweden; Center for Diabetes, Academic Specialist Center, Stockholm, Sweden; Primary Care Group Practice Sanacare, Lugano, Switzerland; Novo Nordisk Service Centre India Pvt Ltd, Bangalore, India; Aarup Health Center I/S, Aarup, Denmark; University of Warwick, Coventry; George Eliot Hospital NHS Trust, Nuneaton; Spaarne Ziekenhuis Hoofddorp, The Netherlands; University of British Columbia, Vancouver, Canada
Other Contributors
Publication date
2024-11-13
Subject
Collections
Research Projects
Organizational Units
Journal Issue
Abstract
Introduction: Oral semaglutide is a glucagon-like peptide 1 receptor agonist (GLP-1RA) approved for improving glycemic control in adults with type 2 diabetes (T2D). The PIONEER REAL program evaluates clinical and patient-reported outcomes of oral semaglutide treatment as part of routine clinical practice across 13 countries. Here, data from Canada, Denmark, Italy, the Netherlands, Sweden, Switzerland, and the UK are pooled and analyzed to address treatment satisfaction as well as glycated hemoglobin (HbA1C) and body weight changes in relevant subgroup analyses.
Methods: This pooled analysis encompasses seven country-specific, non-interventional, multicenter, phase 4, prospective, single-arm clinical studies assessing the use of oral semaglutide in adults with T2D. Primary endpoint was the change in HbA1C from baseline to end of study (EOS), and secondary endpoints included changes in body weight and treatment satisfaction. For the analyses, results were stratified by age, T2D duration, and oral semaglutide dose at EOS as well as baseline HbA1C, body weight, and body mass index.
Results: Oral semaglutide treatment was initiated by 1615 participants. At EOS, 1222 (76%) participants out of the 1483 (92%) who completed the study were on treatment. Estimated changes in HbA1C and body weight from baseline to week 38 were - 1.0%-point (95% CI - 1.08 to - 0.97; P < 0.0001) and - 5.0% (CI - 5.37 to - 4.72; P < 0.0001). Treatment satisfaction increased significantly during the study. Shorter T2D duration interacted with higher HbA1C reduction and body weight loss. Interaction was also observed between higher baseline HbA1C and more pronounced decrease in HbA1C. No significant interactions were detected between clinical outcomes and age or physician setting.
Conclusion: The PIONEER REAL pooled analysis shows that people initiating oral semaglutide treatment experience improved glycemic control and body weight loss across age groups and T2D duration. This occurs regardless of specialist or primary care practice setting and is accompanied by an increased treatment satisfaction.
Clinical trial registrations: NCT04559815 (Canada), NCT04537637 (Denmark), NCT05230615 (Italy), NCT04601740 (the Netherlands), NCT04601753 (Sweden), NCT04537624 (Switzerland), NCT04862923 (UK).
Keywords: Body weight; GLP-1 receptor agonist; Glucose-lowering medication; Glycemic control; HbA1C; Incretin therapy; Real-world evidence; Semaglutide; Type 2 diabetes.
Citation
Rudofsky G, Amadid H, Braae UC, Catrina SB, Kick A, Mandavya K, Roslind K, Saravanan P, van Houtum W, Jain AB. Oral Semaglutide Use in Type 2 Diabetes: A Pooled Analysis of Clinical and Patient-Reported Outcomes from Seven PIONEER REAL Prospective Real-World Studies. Diabetes Ther. 2025 Jan;16(1):73-87. doi: 10.1007/s13300-024-01668-6. Epub 2024 Nov 13.
Type
Article
Description
This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/.