Efficacy and safety of oral semaglutide by baseline age in Japanese patients with type 2 diabetes: A subgroup analysis of the PIONEER 9 and 10 Japan trials

• DOI: 10.1111/dom.14571
• Publication Date: 2021-10-09T02:52:05Z
• Authors: Yuichiro Yamada; Daisuke Yabe; Christin Løth Hertz; Hiroshi Horio; Jiro Nakamura; Anne Møller Nielsen; Yutaka Seino
• Keywords: Glycated Hemoglobin; Brief Report; Glucagon-Like Peptides; Administration, Oral; 3. Good health; 03 medical and health sciences; 0302 clinical medicine; Diabetes Mellitus, Type 2; Japan; Humans; Hypoglycemic Agents; Aged

AbstractA post‐hoc exploratory analysis of the PIONEER 9 and 10 trials evaluated the effect of baseline age (<65 and ≥65 years) on the efficacy and safety of oral semaglutide in Japanese patients with type 2 diabetes. In PIONEER 9 and 10, patients were randomized to once‐daily oral semaglutide (3, 7 or 14 mg) or a comparator (placebo or once‐daily subcutaneous liraglutide 0.9 mg [PIONEER 9]; once‐weekly subcutaneous dulaglutide 0.75 mg [PIONEER 10]) for 52 weeks, with 5 weeks’ follow‐up. In total, 701 patients were included (PIONEER 9: N = 243; PIONEER 10: N = 458). Glycaemic efficacy of oral semaglutide was similar in Japanese patients aged <65 years compared with those ≥65 years, and there did not appear to be a clear pattern between age subgroup and body weight changes. Across treatment arms, adverse events generally occurred in greater proportions of patients aged ≥65 versus <65 years. There was generally a higher rate of premature trial product discontinuation because of adverse events in the older age group. These results indicate that oral semaglutide is efficacious in Japanese patients irrespective of age.