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

• Published in: Journal of diabetes investigation 2022-06, Vol.13 (6), p.975-985
• Main Authors: Yabe, Daisuke, Deenadayalan, Srikanth, Horio, Hiroshi, Kaneto, Hideaki, Jensen, Thomas Bo, Terauchi, Yasuo, Yamada, Yuichiro, Inagaki, Nobuya
• Format: Article
• Language: English
• Subjects: Administration, Oral; Antidiabetics; Body mass index; Clinical trials; Diabetes; Diabetes mellitus (non-insulin dependent); Diabetes Mellitus, Type 2 - chemically induced; Diabetes Mellitus, Type 2 - drug therapy; Glucagon-Like Peptides - adverse effects; Glucagon‐like peptide‐1 analog; Glucose; Glycated Hemoglobin A - analysis; Glycemic control; Hemoglobin; Humans; Hypoglycemic Agents - adverse effects; Japan; Original; Patients; Peptides; Placebos; Safety; Sodium-glucose cotransporter; Statistical analysis; Sulfonylurea; Treatment Outcome; Type 2 diabetes
• ISSN: 2040-1116; 2040-1124
• DOI: 10.1111/jdi.13764

Aims/Introduction To assess the impact of baseline characteristics on the efficacy and safety of oral semaglutide in Japanese patients with type 2 diabetes. Materials and Methods In the Peptide InnOvatioN for Early diabEtes tReatment (PIONEER) 9 and 10 trials, Japanese 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 in PIONEER 9; once‐weekly subcutaneous dulaglutide 0.75 mg in PIONEER 10) for 52 weeks, with 5 weeks of follow up. An exploratory analysis grouped patients in each trial according to baseline glycated hemoglobin (HbA1c; ≤8.0, >8.0–≤9.0, or >9.0%), body mass index (