OBJECTIVES: We present a pooled analysis of PIONEER REAL studies from Canada (NCT04559815), Denmark (NCT04537637), Sweden (NCT04601753), Switzerland (NCT04537624), the Netherlands (NCT04601740), and the UK (NCT04862923). The aim was to assess clinical and patient-reported outcomes of oral semaglutide use in adults with type 2 diabetes (T2D) in routine clinical practice. Additionally, the study aimed to examine HbA_1c changes in subgroup analyses according to baseline age and physician setting.

METHODS: PIONEER REAL encompasses 34-44-week, multicentre, prospective, non-interventional, single-arm, phase 4 studies of adults with T2D naive to injectable glucose-lowering medication who were initiated on oral semaglutide in routine clinical practice. Changes in HbA_1c, body weight (BW), and treatment satisfaction (assessed via Diabetes Treatment Satisfaction Questionnaires (DTSQ status and change)) were evaluated from baseline to end of study (EOS).

RESULTS: Out of 1170 participants, 1085 (93%) completed the study, and 871 (74%) remained on oral semaglutide. At baseline, participants had a mean (SD) HbA_1c of 7.7 (0.4)% and BW of 96.7 (3.4) kg. HbA_1c and BW were significantly reduced from baseline to EOS with ‑1.06%-points and -5.2%, respectively (both p < 0.0001). Participants reported improved treatment satisfaction at EOS, with a DTSQ status increase of 2.35 points and a DTSQ change of 12.15 points (both p < 0.0001). Subgroup analyses from baseline to EOS showed an HbA_1c change of -1.07%-points for participants < 60 years and -1.06%-points for participants ≥ 60 years . An HbA_1c change of -1.02%-points was observed for participants treated by general physicians and ‑1.17%‑points for participants treated by specialists (all p < 0.0001). No significant differences were found between the respective subgroups.

CONCLUSIONS: This PIONEER REAL pooled analysis demonstrated significant HbA_1c and BW reductions, along with improved treatment satisfaction, consistent with outcomes observed for all individual countries. Subgroup analyses by baseline age and physician setting showed comparable significant reductions of HbA_1c.