Efficacy and Safety of Escalating the Dose of Oral Semaglutide from 7 to 14mg: A Single-Center, Retrospective Observational Study.

Abstract

The efficacy and safety of oral semaglutide, the first glucagon-like peptide1 receptor agonist available in tablet form for the treatment of type2 diabetes, were established in the phase3a PIONEER program. However, evidence regarding the titration of oral semaglutide in real-world clinical settings remains insufficient. This study aimed to elucidate the therapeutic advantages of escalating the dose of oral semaglutide from 7 to 14mg through clinical data analysis. This retrospective observational study was conducted at a single center in Japan, focusing on adults with type2 diabetes who were initiated on 14mg oral semaglutide. The primary endpoint was the alteration in HbA1c levels 24weeks after the initial prescription of 14mg oral semaglutide. Secondary endpoints included changes in metabolic parameters and the incidence of adverse events. Data from 66 patients who met the inclusion criteria were analyzed. The mean change in HbA1c levels from baseline to 24weeks following dose escalation was - 0.5 ± 0.8% [from 7.4 ± 1.0% at baseline to 7.0 ± 0.9% at 24weeks (p < 0.01)]. Moreover, a significant reduction in body weight of - 2.0 ± 4.4kg was observed at 24weeks [from 90.0 ± 20.5kg at baseline to 88.2 ± 21.4kg at 24weeks (p < 0.01)], with 41% of patients achieving at least a 3% reduction compared to baseline. Gastrointestinal disorders emerged as the most prevalent adverse event (10.6%), particularly nausea (7.6%), although predominantly of mild or moderate severity, with no instances of serious adverse events necessitating drug discontinuation. Escalating the dose of oral semaglutide to 14mg could be an effective approach for enhancing glycemic control and managing body weight in individuals with type2 diabetes.