PIONEER REAL UK : a multi-centre, prospective, real-world study of once-daily oral semaglutide use in adults with type 2 diabetes
Saravanan, Ponnusamy Bell, Heather Braae, Uffe Christian Collins, Edward Deinega, Alisa Dhatariya, Ketan Machell, Alena Trent, Antonia Strzelecka, Anna
Saravanan, Ponnusamy
Bell, Heather
Braae, Uffe Christian
Collins, Edward
Deinega, Alisa
Dhatariya, Ketan
Machell, Alena
Trent, Antonia
Strzelecka, Anna
Affiliation
University of Warwick, Coventry; George Eliot Hospital NHS Trust, Nuneaton; Old School Surgery, Greenisland, Carrickfergus; Novo Nordisk A/S, Søborg, Denmark; Novo Nordisk Ltd, Gatwick; Norfolk and Norwich University Hospitals NHS Foundation Trust; University of East Anglia, Norwich; Egremont Medical Centre, Wallasey; Northern Health and Social Care Trust, Newtownabbey
Other Contributors
Publication date
2024-09-24
Subject
Collections
Research Projects
Organizational Units
Journal Issue
Abstract
Introduction: Oral semaglutide provides an alternative to injectable glucagon-like peptide-1 receptor agonists (GLP-1RAs) for treatment of type 2 diabetes (T2D). The PIONEER REAL studies evaluate clinical outcomes of oral semaglutide treatment of T2D in a real-world setting. PIONEER REAL UK focused on adults living with T2D in the UK.
Methods: The multi-centre, prospective and non-interventional single-arm study enrolled 333 participants and followed them for 34-44 weeks. Participants were treated as part of routine clinical practice and had not been previously treated with injectable glucose-lowering medication. The primary endpoint was change in glycated haemoglobin (HbA1C) from baseline to end of study (EOS). Secondary endpoints included change in body weight, proportion of participants with HbA1C < 7% (53 mmol/mol) at EOS and proportion of participants with ≥ 1%-point HbA1C reduction and body weight reduction of ≥ 3% or ≥ 5% at EOS. Treatment satisfaction was assessed by Diabetes Treatment Satisfaction Questionnaire (DTSQ) status and change.
Results: Of 333 participants, 299 completed the study and 227 were on treatment at EOS. People treated with oral semaglutide experienced significantly reduced HbA1C by an estimated change of - 1.1%-points (95% CI - 1.27 to - 0.96; P < 0.0001) or - 12.2 mmol/mol (CI - 13.87 to - 10.47; P < 0.0001). Estimated change in body weight was - 4.8 kg (CI - 5.47 to - 4.12; P < 0.0001). At EOS, an HbA1C level < 7% (53 mmol/mol) was recorded in 46.3% of participants. A ≥ 1%-point reduction in HbA1C combined with a ≥ 3% reduction in body weight was observed in 36.4% of participants, and 27.1% had a ≥ 1%-point reduction in HbA1C and a ≥ 5% body weight reduction. Treatment satisfaction improved significantly during the study. No new safety concerns or cases of severe hypoglycaemia were reported.
Conclusion: People living with T2D in the UK experienced a meaningful decrease in HbA1C and body weight after initiation of oral semaglutide treatment. No new safety issues were observed.
Trial registration: ClinicalTrials.gov: NCT04862923. Graphical plain language summary available for this article.
Keywords: Body weight; GLP-1 receptor agonist; Glucose-lowering medication; Glycaemic control; HbA1C; Incretin therapy; Real-world evidence; Semaglutide; Type 2 diabetes.
Citation
Saravanan P, Bell H, Braae UC, Collins E, Deinega A, Dhatariya K, Machell A, Trent A, Strzelecka A. PIONEER REAL UK: A Multi-Centre, Prospective, Real-World Study of Once-Daily Oral Semaglutide Use in Adults with Type 2 Diabetes. Adv Ther. 2024 Nov;41(11):4266-4281. doi: 10.1007/s12325-024-02973-z. Epub 2024 Sep 24.
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/.