open access publication

Article, 2024

Use of once‐daily oral semaglutide and associated clinical outcomes among adults with type 2 diabetes in routine clinical practice in Canada: A multicentre, prospective real‐world study (PIONEER REAL Canada)

Diabetes Obesity and Metabolism, ISSN 1463-1326, 1462-8902, Volume 26, 5, Pages 1799-1807, 10.1111/dom.15493

Contributors

Jain, Akshay B 0000-0001-8515-5359 [1] [2] Reichert, Sonja Maria 0000-0003-3914-7010 (Corresponding author) [3] Amadid, Hanan [4] Braae, Uffe Christian 0000-0002-2743-4584 [4] Bradley, Ryan M [5] Kim, James W. [6] Soo, Victoria [3] Yale, Jean-François 0000-0002-7833-9050 [7]

Affiliations

  1. [1] TLC Diabetes and Endocrinology, Surrey, Canada
  2. [NORA names: Canada; America, North; OECD];
  3. [2] University of British Columbia
  4. [NORA names: Canada; America, North; OECD];
  5. [3] Western University
  6. [NORA names: Canada; America, North; OECD];
  7. [4] Novo Nordisk (Denmark)
  8. [NORA names: Novo Nordisk; Private Research; Denmark; Europe, EU; Nordic; OECD];
  9. [5] Novo Nordisk (Canada)
  10. [NORA names: Canada; America, North; OECD];

Abstract

AIM: PIONEER REAL Canada examined real-world clinical outcomes associated with the use of once-daily oral semaglutide in adults with type 2 diabetes. MATERIALS AND METHODS: This was a 34- to 44-week, multicentre, prospective, open-label, non-interventional study in adults who were treatment-naive to injectable glucose-lowering medication and initiated oral semaglutide in routine clinical practice. The primary endpoint was the change in glycated haemoglobin (HbA1c) from baseline to the end of the study (EoS). Secondary endpoints assessed at EoS were change from baseline in body weight (BW); the proportion of participants reaching HbA1c levels <7% and the composite endpoints, HbA1c reduction ≥1% point with BW reduction ≥3% and ≥5%; and treatment satisfaction measured using Diabetes Treatment Satisfaction Questionnaires (DTSQ) status and change. Primary analyses were based on the in-study observation period. RESULTS: In total, 182 participants initiated oral semaglutide (mean age, 58.6 years; HbA1c, 8.0%; BW, 93.7 kg). The estimated changes (95% confidence interval) from baseline to EoS in HbA1c and BW were -1.09% points (-1.24, -0.94; p < .0001) and -7.17% (-8.24, -6.11; p < .0001), respectively. At EoS, 53.7% of participants had HbA1c levels <7%; 39.3% and 31.6% reached HbA1c reduction ≥1% point plus BW reduction ≥3% and ≥5%, respectively. Treatment satisfaction significantly increased (DTSQ status, +4.47 points; DTSQ change, 11.83 points; both p < .0001). At EoS, 75.3% of participants remained on oral semaglutide (55.5% received oral semaglutide 14 mg). No new safety signals were identified for oral semaglutide. CONCLUSIONS: In PIONEER REAL Canada, participants treated with oral semaglutide in routine clinical practice experienced clinically relevant reductions in HbA1c and BW and increased treatment satisfaction.

Keywords

Canada, Diabetes Treatment Satisfaction Questionnaire, EOS, HbA1c, HbA1c levels <7% (, Secondary endpoints, Treatment Satisfaction Questionnaire, adults, analysis, baseline, baseline to EOS, body, body weight, changes, clinic, clinical outcomes, clinical practice, clinically relevant reduction, composite endpoint, diabetes, endpoint, estimate changes, glucose-lowering medications, glycated hemoglobin, hemoglobin, increased treatment satisfaction, medication, multicentre, non-interventional study, observation period, once-daily oral semaglutide, open-label, oral semaglutide, outcomes, participants, period, pioneer, point, practice, primary analysis, primary endpoint, proportion, proportion of participants, questionnaire, real-world study, reduction, relevant reduction, safety, safety signals, satisfaction, satisfaction questionnaire, semaglutide, signal, status, study, treatment, treatment satisfaction, type, type 2 diabetes, weight

Funders

  • Novo Nordisk (Japan)
  • Novo Nordisk (Denmark)
  • Canadian Institutes of Health Research
  • Lundbeck (Denmark)
  • Diabetes Canada

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