PIONEER REAL Spain: A multicentre, prospective, real-world study of oral semaglutide use in adults with type 2 diabetes.

AIMS: This study evaluated clinical outcomes of oral semaglutide treatment in adults with type 2 diabetes (T2D) in a real-world setting in Spain as part of the 13-country PIONEER REAL programme. MATERIALS AND METHODS: This multicentre, prospective, non-interventional, single-arm study (NCT05443334) followed participants for 34-44 weeks. Participants were treated as part of routine clinical practice and were naïve to injectable glucose-lowering medication. The primary endpoint was the change in glycated haemoglobin (HbA) from baseline to end of study (EOS). Secondary endpoints included changes in body weight, the proportion of participants with HbA <7% at EOS, and treatment satisfaction. Selected outcomes were stratified (post hoc) by sodium-glucose cotransporter-2 inhibitor (SGLT2i) co-use and T2D duration. RESULTS: While 430 participants completed the study, 392 were on treatment at EOS. Estimated change in HbA was -1.4%-points (95%CI -1.5, -1.3; p < 0.0001) and in body weight -6.8% (95%CI -7.4, -6.1; p < 0.0001). In participants using SGLT2is, change in HbA was -1.8%-points (95%CI -2.1, -1.6; p < 0.0001) versus -1.2%-points (95%CI -1.3, -1.1; p < 0.0001) in participants without SGLT2is. HbA change was -1.4%-points (95%CI -1.6, -1.3; p < 0.0001) in participants with T2D duration ≤5 years versus -1.2%-points (95%CI -1.3, -1.0; p < 0.0001) with T2D duration >5 years. At EOS, 77.4% of participants achieved an HbA level <7% and 33.3% had ≥1%-point reduction in HbA and ≥5% body weight reduction. Treatment satisfaction increased, and no new safety concerns were identified. CONCLUSIONS: Oral semaglutide treatment improved glycaemic control and reduced body weight in Spanish clinical practice. Early intervention and SGLT2i co-treatment were associated with more favourable outcomes.