open access publication

Article, 2024

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

Diabetes Therapy, ISSN 1869-6953, 1869-6961, Pages 1-20, 10.1007/s13300-024-01588-5

Contributors

van Houtum, William (Corresponding author) [1] Schrömbges, Patrick [2] Amadid, Hanan [3] Van Bon, Arianne C [4] Braae, Uffe Christian 0000-0002-2743-4584 [3] Hoogstraten, Charlotte 0009-0005-4262-7420 [5] Herrings, Hans [6]

Affiliations

  1. [1] Spaarne Gasthuis
    2. [NORA names: Netherlands; Europe, EU; OECD];
  2. [2] Tunnis Huisartsen, Sint Anthonis, The Netherlands
    3. [NORA names: Netherlands; Europe, EU; OECD];
  3. [3] Novo Nordisk (Denmark)
    4. [NORA names: Novo Nordisk; Private Research; Denmark; Europe, EU; Nordic; OECD];
  4. [4] Rijnstate Hospital
    5. [NORA names: Netherlands; Europe, EU; OECD];
  5. [5] Novo Nordisk A/S, Alphen aan den Rijn, The Netherlands
    6. [NORA names: Netherlands; Europe, EU; OECD];

Abstract

IntroductionIn this phase 4, multicentre, prospective, non-interventional PIONEER REAL Netherlands study, we assessed clinical outcomes associated with once-daily oral semaglutide use in real-world clinical practice in adults living with type 2 diabetes (T2D) naïve to injectable glucose-lowering medication.MethodsParticipants initiated on oral semaglutide were followed for 34–44 weeks. Change in glycated haemoglobin (HbA1c) from baseline (BL) to end of study (EOS) was the primary endpoint; secondary endpoints included change in body weight (BW) from BL to EOS, the proportion of participants with HbA1c < 7.0% at EOS and the composite endpoints of HbA1c reduction ≥ 1.0%-points with BW reduction ≥ 3% or ≥ 5% at EOS. Treatment satisfaction was assessed using the Diabetes Treatment Satisfaction Questionnaire (DTSQ status/change). Safety was evaluated in all participants who initiated oral semaglutide treatment.ResultsOral semaglutide was initiated in 187 participants; 94.1% completed the study and 78.6% remained on treatment at EOS. At BL, 54.0% of participants were male, mean age was 58.8 years, mean duration of T2D was 8.7 years and mean body mass index was 35.1 kg/m2; mean HbA1c was 8.6% and mean BW was 103.1 kg. Significant improvements from BL to EOS were observed for HbA1c and BW (estimated change [95% confidence interval]: − 1.16%-points [− 1.48 to − 0.85]; p < 0.0001, and − 5.84 kg [− 6.88 to − 4.80]; p < 0.0001, respectively). At EOS, 47.5% of participants had an HbA1c level < 7.0%; 41.8% and 35.5% of participants achieved composite endpoints of HbA1c reduction ≥ 1.0%-points plus BW reduction ≥ 3% or ≥ 5%, respectively. DTSQ status and change scores improved by 2.1 (p = 0.0003) and 10.8 points (p < 0.0001), respectively. Oral semaglutide was easy or very easy to consume for 81.5% of participants. Adverse events were mostly mild/moderate, with gastrointestinal disorders being the most common.ConclusionIn this real-world population, we reported clinically significant reductions in HbA1c and BW, improved treatment satisfaction and no new safety concerns.A graphical abstract is available with this article.Clinical Trial RegistrationNCT04601740.Graphical Abstract

Keywords

Abstract, BW reduction, Diabetes Treatment Satisfaction Questionnaire, EOS, Graphical abstract, HbA1c, HbA1c levels, HbA1c reduction, MethodsParticipants, Netherlands Study, ResultsOral semaglutide, Secondary endpoints, T2D, Treatment Satisfaction Questionnaire, adults, adverse events, age, article, baseline, body, body mass index, body weight, change scores, changes, clinic, clinical practice, clinically significant reduction, composite endpoint, concerns, diabetes, disorders, duration, duration of T2D, endpoint, events, gastrointestinal disorders, glucose-lowering medications, glycated hemoglobin, hemoglobin, improved treatment satisfaction, improvement, index, levels, male, mass index, mean body mass index, medication, multicentre, observational study, observations, oral semaglutide, participants, phase, phase 4, pioneer, population, practice, primary endpoint, proportion, proportion of participants, prospects, questionnaire, real world, real-world population, real-world use, reduction, safety, safety concerns, satisfaction, satisfaction questionnaire, scores, semaglutide, semaglutide treatment, significant reduction, status, study, treatment, treatment satisfaction, type, type 2 diabetes, use, weeks, weight, years

Funders

  • Novo Nordisk (Denmark)

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