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PIONEER REAL Sweden: A Multicentre, Prospective, Real-World Observational Study of Oral Semaglutide Use in Adults with Type 2 Diabetes in Swedish Clinical Practice
Department of Molecular Medicine and Surgery, Karolinska Institute, Stockholm, Sweden; Centrum for Diabetes, Academic Specialist Centrum, Stockholm, Sweden; K1 Molekylär Medicin Och Kirurgi, K1 MMK Tillväxt & Metabolism, Stockholm, Sweden.
Novo Nordisk A/S, Søborg, Denmark.
Novo Nordisk A/S, Søborg, Denmark.
Novo Nordisk A/S, Søborg, Denmark.
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2024 (English)In: Diabetes Therapy, ISSN 1869-6953, E-ISSN 1869-6961, Vol. 15, no 9, p. 2079-2095Article in journal (Refereed) Published
Abstract [en]

Introduction: The study was designed to assess outcomes with once-daily oral semaglutide in adults with type 2 diabetes (T2D) na & iuml;ve to injectable glucose-lowering agents, in Swedish clinical practice.

Methods: In this non-interventional, multicentre study, participants initiated oral semaglutide and were followed for 34-44 weeks. The primary endpoint was glycated haemoglobin (HbA(1c)) change from baseline to end of study (EOS). Secondary endpoints included body weight (BW) change from baseline to EOS, proportion of participants achieving HbA(1c) < 7%, and proportion achieving both a HbA(1c) reduction >= 1% and BW reduction of >= 3% or >= 5%, at EOS. Participants completed Diabetes Treatment Satisfaction Questionnaires (DTSQ status/change) and a dosing conditions questionnaire.

Results: A total of 187 participants (mean age 62.5 years) initiated oral semaglutide. Baseline mean HbA(1c) and BW were 7.8% (n = 177) and 96.9 kg (n = 165), respectively. Estimated mean changes in HbA(1c) and BW were - 0.88%-points (95% confidence interval [CI] - 1.01 to - 0.75; P < 0.0001) and - 4.72% (95% CI - 5.58 to - 3.86; P < 0.0001), respectively. At EOS, 64.6% of participants had HbA(1c) < 7%, and 22.9% achieved HbA(1c) reduction of >= 1% and BW reduction of >= 5%. DTSQ status and change scores improved by 1.44 (P = 0.0260) and 12.3 points (P < 0.0001), respectively. Oral semaglutide was easy or very easy to consume for 86.4% of participants. Most common adverse events (AEs) were gastrointestinal disorders; nine participants (4.8%) had serious AEs; one (0.5%) experienced severe hypoglycaemia.

Conclusion: In this real-world study population, we observed significant reductions in HbA(1c) and BW in people living with T2D when prescribed semaglutide tablets as part of routine clinical practice in Sweden, with improved treatment satisfaction among participants and no new safety concerns.

Place, publisher, year, edition, pages
Springer, 2024. Vol. 15, no 9, p. 2079-2095
Keywords [en]
Body weight, GLP-1 receptor agonist, Glycaemic control, HbA(1c), Incretin therapy, Real-world evidence, Semaglutide, Type 2 diabetes
National Category
Endocrinology and Diabetes
Identifiers
URN: urn:nbn:se:oru:diva-115375DOI: 10.1007/s13300-024-01614-6ISI: 001277196500001PubMedID: 39052163Scopus ID: 2-s2.0-85199564797OAI: oai:DiVA.org:oru-115375DiVA, id: diva2:1889707
Funder
Novo Nordisk, NCT04601753Available from: 2024-08-16 Created: 2024-08-16 Last updated: 2024-09-02Bibliographically approved

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