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Clinical Trial
. 2024 Nov;41(11):4266-4281.
doi: 10.1007/s12325-024-02973-z. Epub 2024 Sep 24.

PIONEER REAL UK: A Multi-Centre, Prospective, Real-World Study of Once-Daily Oral Semaglutide Use in Adults with Type 2 Diabetes

Ponnusamy Saravanan  1   2   3 , Heather Bell  4 , Uffe Christian Braae  5 , Edward Collins  6 , Alisa Deinega  5 , Ketan Dhatariya  7   8 , Alena Machell  9 , Antonia Trent  6 , Anna Strzelecka  10
Affiliations
Clinical Trial

PIONEER REAL UK: A Multi-Centre, Prospective, Real-World Study of Once-Daily Oral Semaglutide Use in Adults with Type 2 Diabetes

Ponnusamy Saravanan et al. Adv Ther. 2024 Nov.

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.

Plain language summary

PIONEER REAL UK investigated the use of a tablet form of the medicine semaglutide in people living with type 2 diabetes in the UK. The purpose was to determine how well the tablet works for blood sugar control and weight loss in everyday clinical practice. The study followed 333 participants whose doctors had given them semaglutide tablets. Their blood sugar levels and body weight were measured before and after taking the semaglutide tablet for 34–44 weeks. The participants were also asked to fill out questionnaires about their treatment satisfaction and how it changed when taking the semaglutide tablet. The participants’ blood sugar levels dropped a lot, and body weight was lowered by an average of 4.8 kg during the 34–44 weeks of the study. The participants were also more satisfied with their treatment at the end of the study than before taking the semaglutide tablet. Doctors treating the participants found the treatment to be a success in more than two-thirds of participants. The study also found that the semaglutide tablet was not associated with cases of too low blood sugar and was generally well tolerated. In summary, the semaglutide tablet is a good option for people living with type 2 diabetes who need better blood sugar control and would benefit from weight loss. The treatment is generally well tolerated, and people are very satisfied with it.

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Conflict of interest statement

The authors disclose the following competing interests: Ponnusamy Saravanan: honoraria or travel support from Novo Nordisk and Abbott, UK; an unrestricted educational grant from Novo Nordisk A/S to set up an international Doctoral Training Partnership. Heather Bell: honoraria, travel support or fees for advisory boards from Abbott, Astra Zeneca, Boehringer Ingelheim, Eli Lilly, Menarini, Novo Nordisk, PCDS, Roche. Uffe Christian Braae: employee and shareholder of Novo Nordisk A/S. Edward Collins: employee and shareholder of Novo Nordisk A/S. Alisa Deinega: employee of Novo Nordisk A/S. Ketan Dhatariya: honoraria, travel support or fees for advisory boards from AstraZeneca, Novo Nordisk, Boehringer-Ingelheim, Eli Lilly, Abbott Diabetes, Menarini, Sanofi. Alena Machell: honoraria, travel support or fees for advisory boards from Novo Nordisk, Abbott. Antonia Trent: employee of Novo Nordisk A/S. Anna Strzelecka: honoraria from Astra Zeneca, Boehringer Ingelheim, Janssen, Lilly, MSD, Novo Nordisk, NAPP.

Figures

Fig. 1
Fig. 1
Participant disposition. aParticipants who initiated the oral semaglutide treatment and attended the EOS visit. bParticipants who were on oral semaglutide treatment and attended the EOS visit. EOS end of study; Epi-/Pandemic COVID-19-related issue or similar
Fig. 2
Fig. 2
Changes in HbA1c and body weight. A Observed HbA1C at baseline (mean with SD is plotted) and estimated mean HbA1C at week 38 (plotted with 95% CI) in % and mmol/mol as well as estimated change from baseline to week 38 in %-points and in mmol/mol. B Estimated HbA1C change from baseline to week 38 stratified by baseline HbA1C in %-points and mmol/mol (mean with 95% CI is plotted). C Absolute and relative estimated body weight change from baseline to week 38 in kg and in % (mean with 95% CI is plotted). D Proportion of participants at HbA1C target at EOS and composite endpoints of HbA1C and body weight reduction at EOS. BW body weight; CI confidence interval; EOS end of study; HbA1C glycated haemoglobin; SD standard deviation
Fig. 3
Fig. 3
Change in treatment satisfaction. A Change in absolute treatment satisfaction. B Relative treatment satisfaction at EOS. DTSQc diabetes treatment satisfaction questionnaire-change; DTSQs diabetes treatment satisfaction questionnaire-status; EOS end of study; FAS full analysis set
See this image and copyright information in PMC

References

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