(DCP031) CLINICAL OUTCOMES ASSOCIATED WITH THE USE OF ORAL SEMAGLUTIDE IN AN ADULT POPULATION WITH TYPE 2 DIABETES IN CANADA: A PROSPECTIVE REAL-WORLD STUDY (PIONEER REAL CANADA)

Background: In the phase 3a PIONEER program, oral semaglutide demonstrated superiority versus most comparators for reductions in HbA1c and body weight (BW). PIONEER REAL Canada is part of the PIONEER REAL program, which comprises 13 non interventional real-world studies in multiple countries and is investigating clinical outcomes associated with once daily oral semaglutide use in routine clinical practice in adults with type 2 diabetes (T2D).

METHODS AND RESULTS: PIONEER REAL Canada was a 34─44-week, multicenter, prospective, open-label, non interventional, single armed, phase 4 study in adults with T2D naive to injectable glucose-lowering medication, initiated on oral semaglutide in routine clinical practice. Changes in HbA1c (primary endpoint) and BW (secondary endpoint) were assessed from baseline to week 38. HbA1c and weight-loss targets, and treatment satisfaction assessed using Diabetes Treatment Satisfaction Questionnaires (DTSQ status and change; secondary endpoints) were assessed from baseline to end of study (EOS; visit between weeks 34 and 44). Analyses were based on the in-trial observation period.

Of 182 participants initiating oral semaglutide, 171 (94%) completed the study and 137 (75.3%) remained on treatment with oral semaglutide at EOS. At baseline, participants had a mean (standard deviation) age of 58.6 (10.92) years, HbA1c of 8.0 (1.36) % and BW of 93.7 (22.72) kg; 19.7% of participants had HbA1c < 7%, and 70.3% of participants were receiving concomitant glucose-lowering medications. HbA1c and BW were significantly reduced from baseline to week 38 (estimated mean change [95% confidence interval – CI] –1.1% points [–1.24, –0.94; Figure 1] and –7.2% [–8.24, –6.11], respectively; both p< 0.0001). At EOS, 53.7% of participants had an HbA1c < 7%, while an HbA1c reduction ≥1% plus BW reduction ≥3% or ≥5% was reached by 39.3% and 31.6% of participants, respectively. Participants reported a significant improvement in treatment satisfaction (estimated mean [95% CI] increase in DTSQ status, 4.2 points [3.18, 5.25] from baseline to EOS; DTSQ change, 11.8 points [10.64,12.91] at EOS; both p< 0.0001). No new safety concerns were identified for oral semaglutide.

Conclusion: In the PIONEER REAL Canada study assessing oral semaglutide treatment in routine clinical practice, clinically and statistically significant reductions in HbA1c and BW were reported, with improved treatment satisfaction in a real-world setting.