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Efficacy of oral semaglutide according to baseline HbA1c: An exploratory subgroup analysis of the PIONEER trial programme

Juris Meier,1 Robert Bauer,2 Thalia Blicher,2 Ildiko Lingvay,3 Marianne Treppendahl (mbtp@novonordisk.com),2 Bernard Zinman,4 Julio Rosenstock5

1St Josef Hospital, Ruhr-University Bochum, Bochum, Germany; 2Novo Nordisk A/S, Søborg, Denmark; 3University of Texas Southwestern Medical Center at Dallas, Dallas, TX, USA; 4Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Toronto, ON, Canada; 5Dallas Diabetes Research Center at Medical City, Dallas, TX, USA

 

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Efficacy of oral semaglutide according to baseline HbA1c: An exploratory subgroup analysis of the PIONEER trial programme

 

Video

Poster Slides

Aim

  • Oral semaglutide, a glucagon-like peptide-1 receptor agonist, was investigated in patients with type 2 diabetes in the PIONEER programme.
  • This exploratory subgroup analysis evaluated efficacy and safety by baseline HbA1c 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 HbA1c (≤8%, >8–≤9% and >9%).
  • Efficacy endpoints (change in HbA1c and body weight) were assessed at week 26 (week 52 in PIONEER 7).
  • Adverse event (AE) data were pooled from placebo- and comparator-controlled trials.

Key results

  • Greater HbA1c reductions were observed with oral semaglutide with increasing baseline HbA1c (Figure).
    • HbA1c reductions were greater with oral semaglutide 7 and 14 mg vs comparators.
  • Significant interactions by baseline HbA1c were observed for oral semaglutide vs sitagliptin in PIONEER 3 (14 mg), and vs placebo in PIONEER 4 (14 mg) and PIONEER 8 (7 and 14 mg).
  • In a pooled analysis vs placebo, there was a significant interaction by baseline HbA1c on HbA1c reductions (see supplementary materials).
  • There was no consistent relationship between change in body weight and baseline HbA1c (see supplementary materials).
  • Overall, the proportions of patients experiencing AEs, serious AEs and gastrointestinal AEs were similar across baseline HbA1c subgroups (see supplementary materials).

Conclusions

Overall, HbA1c reductions were greater with:
  • higher baseline HbA1c
  • oral semaglutide 7 and 14 mg vs comparators across subgroups
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.