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

Aims An exploratory analysis of data from the global phase 3a PIONEER programme (PIONEER 1–5 and 7–8 trials) evaluated the efficacy of once-daily oral semaglutide 3, 7, 14 mg versus comparators by diabetes duration at baseline. Methods: Data were included from all PIONEER 1–5, 7 and 8 participants (n = 5657). Patients were grouped by diabetes duration (< 5, 5– < 10 and ≥ 10 years) and by trial. In PIONEER, patients were randomised to oral semaglutide (3, 7 or 14mg) or comparator (placebo, empagliflozin, sitagliptin or liraglutide). Endpoints: change from baseline in glycated haemoglobin (HbA1c, %) and body weight (kg) at week 26 (week 52 in PIONEER 7); data were analysed for all randomised patients using the trial product estimand. Results: Across trials, mean diabetes duration at baseline ranged from 3.5–15.0 years, with similar mean baseline Hb1Ac (%) across subgroups within each trial. Mean body weight was higher and age was lower in the diabetes duration < 5 years subgroup. HbA1c reductions were generally greater with increasing oral semaglutide dose but were not affected by diabetes duration, and there were generally no statistically significant interactions between treatment and diabetes duration. Estimated treatment differences in HbA1c (%) at week 26 (week 52 in PIONEER 7) were consistent across diabetes duration subgroups. Conclusions: Across the PIONEER trials, oral semaglutide improved glycaemic control versus comparators, with consistent effects across diabetes duration subgroups. These findings support the use of oral semaglutide across a broad population of patients with Type 2 diabetes. Presented at EASD, Sept

Publication History

Article published online:
06 May 2021