Oral semaglutide reduces diabetes-related distress in adults with type 2 diabetes mellitus switching from DPP-4 inhibitors. The DOORS prospective real-world Italian study.

AIMS: To evaluate glycemic control, weight management, and patient-reported outcomes (PROs) in adults with type 2 diabetes mellitus who transitioned to oral semaglutide (OS) after inadequate glycemic control on dipeptidyl peptidase-4 inhibitors (DPP-4i). METHODS: This 40-week, observational, prospective study included three visits: baseline (V1, OS initiation), intermediate visits (V2.X), and final visit (V3, week 40 ± 4). The primary endpoint was change in glycated haemoglobin (HbA1c) from V1 to V3. Secondary endpoints included changes in body weight (BW), PROs - assessed by the Diabetes Distress Scale (DDS) and the Dutch Eating Behaviour Questionnaire (DEBQ) - and anthropometric/clinical parameters. RESULTS: 281 patients were enrolled (mean age 67.5 ± 12.0 years; 55.9% male). In the in-study set (all patients initiating OS, regardless of discontinuation), mean HbA1c decreased by - 0.7 ± 0.05% (p < 0.0001), and mean BW decreased by - 3.6 ± 0.22  kg (p < 0.0001) from V1 to V3. Scores on the DDS domains and the DEBQ (emotional and external eating domains) decreased, indicating reduced diabetes-related distress and improved eating behaviours. Adverse events were reported by 23.1% of patients, with no hypoglycaemic episodes observed. CONCLUSIONS: OS was safe and effective in improving glycemic control, reducing BW, and alleviating diabetes-related distress and unhealthy eating behaviors in patients with type 2 diabetes mellitus switched from DPP-4i.