Oral semaglutide treatment resulted in an estimated 1.0%-point reduction in (HbA) and a 5.0% decrease in body weight by week 38.
A total of 1615 participants initiated oral semaglutide treatment, with 1222 (76%) remaining on treatment by the end of the study.
Significant improvements in treatment satisfaction were reported throughout the study duration.
Younger individuals with shorter type 2 diabetes duration experienced greater reductions in HbA and body weight.
Higher baseline HbA levels were associated with more significant decreases in HbA during treatment.
No significant differences in clinical outcomes were observed based on age or whether care was provided in a specialist or primary care setting.
Simplified
INTRODUCTION: Oral semaglutide is a (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 (HbA) and body weight changes in relevant subgroup analyses. 1C
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 HbAfrom 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 HbA, body weight, and body mass index. 1C1C
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 HbAand 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 HbAreduction and body weight loss. Interaction was also observed between higher baseline HbAand more pronounced decrease in HbA. No significant interactions were detected between clinical outcomes and age or physician setting. 1C1C1C1C
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.
Declarations. Conflict of Interest: Gottfried Rudofsky: receives lecture fees from Novo Nordisk. Hanan Amadid: employee and shareholder of Novo Nordisk A/S. Uffe C. Braae: employee and shareholder of Novo Nordisk A/S. Sergiu-Bogdan Catrina: No conflict of interest. Anastas Kick: Lecture/other fees from NovoNordisk and Abbott. Kabirdev Mandavya: employee of Novo Nordisk A/S. Klaus Roslind: Honorarium/Moderator at Novo Nordisk meetings. Ponnusamy Saravanan: International Doctoral Training scholarship Grant from Novo Nordisk; PhD studentship funding from BHR Pharmaceuticals, UK; Joint MRC—Abbott project grant for Magic study; Lecture/other fees from Novo Nordisk, Sanofi, Lilly, Boehringer, Abbott. William van Houtum: No conflict of interest. Akshay B. Jain: Grants from Abbott, Amgen, Novo Nordisk; Honorarium from Abbott, AstraZeneca, Amgen, Bausch Healthcare, Bayer, Boehringer Ingelheim, Care to Know, CCRN, Connected in Motion, CPD Network, Dexcom, Diabetes Canada, Eli Lilly, GSK, HLS Therapeutics, Janssen, Master Clinician Alliance, MDBriefcase, Merck, Medtronic, Moderna, Novartis, Novo Nordisk, Partners in Progressive Medical Education, Pfizer, Timed Right, WebMD; Lecture/other fees from Abbott, AstraZeneca, Amgen, Bausch Healthcare, Bayer, Boehringer Ingelheim, Dexcom, Eli Lilly, Gilead Sciences, GSK, HLS Therapeutics, Insulet, Janssen, Medtronic, Novartis, Novo Nordisk, Partners in Progressive Medical Education, Pfizer, PocketPills, Roche, Takeda, Ypsomed. Ethical Approval: The PIONEER REAL study protocols were approved by local independent ethics committees (IEC), institutional review boards (IRB) or equivalent authorities, and studies were conducted following good pharmacoepidemiology practices (GPP) [25] and good pharmacovigilance practices (GVP) [26] in accordance with the Declaration of Helsinki [27]. All participants signed an informed consent.
