Real-world use of oral semaglutide in adults with type 2 diabetes.

INTRODUCTION: PIONEER REAL Denmark assessed changes in HbA1c, body weight and treatment satisfaction with once-daily oral semaglutide in adults with type 2 diabetes. METHODS: In this multicentre, prospective, open-label, non-interventional study, participants initiated oral semaglutide in routine clinical practice and were followed up for 34-44 weeks. The primary endpoint was change in HbA1c from baseline to the end of study (EOS). Secondary endpoints assessed at EOS included change in body weight (BW), proportion of participants reaching HbA1c less-than 7% and treatment satisfaction using Diabetes Treatment Satisfaction Questionnaire status/change (DTSQs/DTSQc). RESULTS: In total, 96 participants from a primary care setting were included (median age: 63.5 years, HbA1c: 7.6% (60.0 mmol/mol), BW: 97.4 kg). Estimated changes from baseline to EOS in HbA1c (n = 96) and BW (n = 86) were -0.9 percentage points (9.9 mmol/mol) (95% CI: -1.20; -0.61 percentage points) and -4.4 (95% CI: -5.44; -3.41) kg, respectively. At baseline, 28.1% of participants had HbA1c less-than 7.0% (less-than 53 mmol/mol); at EOS, 66.7% of participants had HbA1c less-than 7.0% (53 mmol/mol). Improvements in treatment satisfaction were observed in DTSQs (1.9 points) and DTSQc (10.5 points) scores. No new safety signals were identified for oral semaglutide. CONCLUSIONS: In PIONEER REAL Denmark, participants treated with oral semaglutide in a primary care setting experienced reductions in HbA1c and BW. FUNDING: This study was sponsored by Novo Nordisk A/S. CLINICALTRIALS: gov (NCT04537637).