932-P: Efficacy and Safety of Oral Semaglutide by Baseline Age in the PIONEER Clinical Trial Program

Abstract

In an exploratory analysis of 7 global phase 3a trials (PIONEER 1-5, 7, and 8) we evaluated the effect of age at baseline on efficacy (<45, ≥45-<65, or ≥65 years) and safety (<65 or ≥65 years) for oral semaglutide (3, 7, 14 mg once daily) vs. comparators in patients with type 2 diabetes. Efficacy endpoints were change from baseline in HbA1c and body weight. Across all trials, there were 582, 3392, and 1683 patients aged <45, ≥45-<65, and ≥65 years, respectively. Baseline HbA1c was similar across age groups, whereas baseline body weight tended to be higher in younger patients. Overall, reductions in HbA1c were comparable across age groups for all trials and were generally larger with oral semaglutide than comparators, irrespective of age (Table). Body weight reductions were greater for oral semaglutide vs. comparators but without association between age and reductions in body weight. In general, proportions of patients with adverse advents (AEs) and AEs leading to treatment discontinuation were greater in the ≥65 vs. the <65 age group for oral semaglutide and comparators (Table). To conclude, the greater effects of oral semaglutide vs. comparators on HbA1c and body weight were seen for patients regardless of age group in the global PIONEER trials. For the <65 and ≥65 age groups, the safety profile of oral semaglutide was in line with other GLP-1RAs. Overall, there was a generally higher discontinuation rate in older patients. Disclosure V.R. Aroda: Consultant; Self; Duke, Novo Nordisk Inc., Sanofi. Employee; Spouse/Partner; Merck & Co., Inc. Research Support; Self; Applied Therapeutics, Fractyl Laboratories, Inc., Novo Nordisk Inc., Sanofi. Other Relationship; Self; IMNE, Medscape. R. Bauer: Employee; Self; Novo Nordisk A/S. C.L. Hertz: Employee; Self; Novo Nordisk A/S. E. Montanya: Advisory Panel; Self; Sanofi. Consultant; Self; Novartis Pharmaceuticals Corporation. Employee; Spouse/Partner; Almirall. Speaker’s Bureau; Self; AstraZeneca, Merck Sharp & Dohme Corp., Novo Nordisk A/S. R. Sørrig: Employee; Self; Novo Nordisk A/S. M.L. Warren: Advisory Panel; Self; Eli Lilly and Company, Novo Nordisk Inc., Sanofi. Research Support; Self; Eli Lilly and Company, Gan & Lee Pharmaceuticals, Novo Nordisk Inc., Sanofi. Speaker’s Bureau; Self; AstraZeneca, Merck & Co., Inc., Novo Nordisk Inc., Sanofi. B. Cariou: Advisory Panel; Self; Bristol-Myers Squibb, Gilead Sciences, Inc., Lexicon Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi-Aventis. Board Member; Self; GENFIT. Research Support; Self; Amgen, Regeneron Pharmaceuticals. Speaker’s Bureau; Self; Abbott, AstraZeneca. Funding Novo Nordisk A/S