BACKGROUND: Hypoglycaemia is a serious side effect in the treatment of type 2 diabetes mellitus (T2DM), especially when using insulin and insulin secretagogues such as sulfonylureas. Current guidelines recommend reducing or discontinuing these medications in high-risk populations. This study assessed the real-world effectiveness and safety of oral semaglutide in T2DM patients who suspended or reduced sulfonylurea dosages in favour of oral semaglutide.
METHODS: In this retrospective, multicentre cohort study, the primary endpoint was the change in glycated haemoglobin (HbA1c) from baseline to an average follow-up period of 37 weeks. Secondary endpoints included changes in fasting blood glucose, body weight, the proportion of patients achieving HbA1c ≤7%, and combined reductions in HbA1c (≥1%) and body weight (≥5%). Safety and exploratory endpoints were also evaluated.
RESULTS: The study included 104 patients (mean age: 68.9 ± 9.9 years). Treatment discontinuation occurred in 9.6% of patients, and 12.5% reported adverse events, primarily gastrointestinal; no hypoglycaemic events were reported. HbA1c significantly decreased from 7.62% to 7.42% (p = 0.04, mean reduction of 0.22%) and the proportion of patients achieving HbA1c ≤7% increased from 29.8% to 36.3%. Body weight was significantly reduced by 3.03 kg (p < 0.001). Significant reductions (p < 0.05) were observed in fasting blood sugar, waist circumference, diastolic blood pressure, total cholesterol and albumin-to-creatinine ratio, while HDL cholesterol and estimated glomerular filtration rate increased. The 10-year cardiovascular risk score significantly decreased from 17.0% to 12.9% (p < 0.001).
CONCLUSION: Real-world data suggest that oral semaglutide is an effective and safe alternative to sulfonylureas for T2DM patients, with no reported hypoglycaemic episodes.
