AIMS: The REALISED study assessed the clinical outcomes associated with oral semaglutide use in Thai patients with type 2 diabetes (T2D) in real-world clinical settings.
MATERIALS AND METHODS: This retrospective, multi-centre cohort study included 195 patients with T2D initiating oral semaglutide between April 2022 and December 2023. Eligible participants had no prior injectable therapy and completed at least 26 weeks of treatment. The primary endpoint was the change in HbA1c from baseline to the end-of-study (EoS, Week 26); Week 52 outcomes were exploratory. Secondary endpoints included changes in body weight and the proportion achieving HbA1c < 7%. Severe hypoglycaemia was the safety endpoint. A post hoc composite endpoint combined HbA1c < 7% with ≥ 3% weight loss. Analyses used a mixed model for repeated measures and descriptive statistics.
RESULTS: Oral semaglutide was predominantly used as add-on therapy (190/195 [97.4%]). Mean HbA1c decreased by -0.7% (95% CI: -0.9 to -0.5; p < 0.0001), and the mean body weight decreased by -4.3 kg (95% CI: -5.5 to -3.2; p < 0.0001). At the EoS, 75.9% (117/154) achieved an HbA1c < 7%, and 57.7% (71/123) met the composite endpoint. No severe hypoglycaemia occurred. Dose escalation from 3 mg to 14 mg was observed in 53.2% by Week 26 and 70.4% by Week 52.
CONCLUSIONS: The REALISED study provides the first real-world evidence of the use of oral semaglutide in Thai patients with T2D, demonstrating significant improvements in glycaemic control and weight reduction across routine care settings.
