open access publication

Article, 2024

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

Diabetes Therapy, ISSN 1869-6953, 1869-6961, Volume 15, 3, Pages 623-637, 10.1007/s13300-023-01525-y

Contributors

Kick, Anastas [1] M'Rabet-Bensalah, Khadija 0009-0001-5794-2184 [2] Acquistapace, Flavio [3] Amadid, Hanan [4] Ambühl, Robert A. [5] Braae, Uffe Christian 0000-0002-2743-4584 [4] Item, Flurin 0009-0007-2412-2757 [2] Schultes, Bernd 0000-0002-5301-1163 [6] Züger, Thomas 0000-0001-6190-7405 [7] Rudofsky, Gottfried (Corresponding author) [7] [8]

Affiliations

  1. [1] Primary Care Group Practice Sanacare, Lugano, Switzerland
    2. [NORA names: Switzerland; Europe, Non-EU; OECD];
  2. [2] Novo Nordisk (Switzerland)
    3. [NORA names: Switzerland; Europe, Non-EU; OECD];
  3. [3] SCA: Primary Care Cardiological Practice, Lugano, Switzerland
    4. [NORA names: Switzerland; Europe, Non-EU; OECD];
  4. [4] Novo Nordisk (Denmark)
    5. [NORA names: Novo Nordisk; Private Research; Denmark; Europe, EU; Nordic; OECD];
  5. [5] Primary Care Practice Schöngrund, Rotkreuz, Switzerland
    6. [NORA names: Switzerland; Europe, Non-EU; OECD];

Abstract

IntroductionReal-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).MethodsPIONEER 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 (HbA1c) 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 HbA1c < 7.0% and the composite endpoints HbA1c reduction ≥ 1%-points with BW reduction ≥ 3% or ≥ 5% at EOS. Safety was assessed in participants who received ≥ 1 dose of oral semaglutide.ResultsOf 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, HbA1c 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 HbA1c (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.ConclusionPeople living with T2D treated with oral semaglutide in Switzerland achieved clinically significant reductions in HbA1c and BW, with no new safety signals.Clinical Trial RegistrationClinicalTrials.gov: NCT04537624.A graphical abstract is available for this article.Graphical abstract

Keywords

Abstract, BW reduction, ConclusionPeople, EOS, Graphical abstract, HbA1c, HbA1c reduction, HbA1c < 7.0%, IntroductionReal-world data, Secondary endpoints, Switzerland, Switzerland study, T2D, adults, adverse events, age, article, baseline, body, body mass index, body weight, changes, clinic, clinical outcomes, clinical practice, clinically significant reduction, data, diabetes, diabetes duration, discontinuation, disorders, dose, duration, endpoint, events, frequent adverse events, gastrointestinal disorders, glucose-lowering medications, glycated hemoglobin, hemoglobin, index, mass index, medication, multicentre, non-interventional, observational study, observations, oral semaglutide, outcomes, participants, pioneer, practice, primary endpoint, proportion, proportion of participants, prospects, real world, real-world use, reduction, safety, safety signals, semaglutide, signal, significant reduction, study, treatment, type, type 2 diabetes, weight, years

Funders

  • Novo Nordisk (Denmark)

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