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Efficacy and safety of oral semaglutide according to diabetes duration: An exploratory subgroup analysis of the PIONEER trial programme

Martin Haluzík,1 Robert Bauer,2 Jan Eriksson,3 Søren Hoff,2 Klaus Kallenbach (KLKC@novonordisk.com),2 Richard Pratley,4 John Buse5

1Institute for Clinical and Experimental Medicine and Institute for Endocrinology, Prague, Czech Republic; 2Novo Nordisk A/S, Søborg, Denmark; 3Clinical Diabetology and Metabolism, Department of Medical Sciences, Uppsala University, Uppsala, Sweden; 4AdventHealth Translational Research Institute for Metabolism and Diabetes, Orlando, FL, USA; 5Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, NC, USA

 

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Efficacy and safety of oral semaglutide according to diabetes duration: An exploratory subgroup analysis of the PIONEER trial programme

 

Video

Poster Slides

Aim

  • Oral semaglutide was investigated in patients with type 2 diabetes in the PIONEER trial programme.
  • An exploratory subgroup analysis evaluated efficacy and safety by duration of diabetes at baseline in PIONEER trials.

Methods

  • Data were included from all participants of PIONEER 1–5, 7 and 8 (N=5,657).1–7
  • Patients were randomised to once-daily oral semaglutide (3, 7 or 14 mg, or flexibly dosed) or comparator (placebo, empagliflozin 25 mg, sitagliptin 100 mg or liraglutide 1.8 mg).
  • Patients were grouped according to baseline diabetes duration (<5 years, 5–<10 years and ≥10 years).
  • Endpoints were assessed at week 26 (week 52 in PIONEER 7).
  • Adverse event (AE) data were pooled from placebo- and comparator-controlled trials.

Key results

  • Baseline glycated haemoglobin (HbA1c) was similar across diabetes duration subgroups, while body weight was greater and age lower in the <5 years subgroup (see supplementary materials).
  • Overall, no statistically significant interactions were found between treatment and diabetes duration for change in HbA1c from baseline, except oral semaglutide 3 mg (PIONEER 8) and oral semaglutide 7 mg (PIONEER 3). In both cases, no clear pattern was found (Figure).
  • There were no significant interactions between treatment and diabetes duration for change in body weight from baseline (see supplementary materials).
  • There were no significant interactions between treatment and diabetes duration for the proportion of patients achieving HbA1c <7.0% (see supplementary materials).
  • Overall, the proportions of patients experiencing AEs, serious AEs and gastrointestinal AEs were similar across baseline diabetes duration subgroups (see supplementary materials).

Conclusions

Across the PIONEER trials, the efficacy of oral semaglutide in reducing HbA1c and body weight was unaffected by diabetes duration
Overall, the safety profile was similar across subgroups
References
(1) Aroda VR, et al. Diabetes Care 2019;42:1724–32;
(2) Rodbard HW, et al. Diabetes Care 2019;42:2272–81;
(3) Rosenstock J, et al. JAMA 2019;321:1466–80;
(4) Pratley R, et al. Lancet 2019;394:39–50;
(5) Mosenzon O, et al. Lancet Diabetes Endocrinol 2019;7:515–27;
(6) Pieber TR, et al. Lancet Diabetes Endocrinol 2019;7:528–39;
(7) Zinman B, et al. Diabetes Care 2019;42:2262–71;
(8) Aroda VR, et al. Diabetes Obes Metab 2019;doi:10.1111/dom.13896;
(9) Verma S, et al. Diabetes Obes Metab 2019;21:1745–51.