Once‐weekly semaglutide use in patients with type 2 diabetes: real‐world data from the SURE Italy observational study

Aims: SURE Italy, a multicentre, prospective, open-label, observational, real-world study, investigated once-weekly (OW) semaglutide in patients with type 2 diabetes (T2D) in routine clinical practice. Materials and methods: Adults with T2D and ≥1 documented HbA1c level within 12 weeks of semaglutide initiation were enrolled. The primary endpoint was change in HbA1c from baseline to end of study (EOS; ~30 weeks). Other endpoints included changes in body weight (BW), waist circumference and patient-reported outcomes (PROs), and the proportion of patients achieving HbA1c <7.0% or <6.5%, weight loss ≥5% and a post-hoc composite endpoint (HbA1c reduction of ≥1%-point and weight loss ≥5%). These endpoints were reported for patients on semaglutide at EOS (effectiveness analysis set [EAS]). Safety data were reported in the full analysis set (FAS). Results: Of 579 patients who initiated semaglutide (FAS), 491 completed the study on treatment (EAS). Mean baseline HbA1c was 8.0%, and 20.7% (120/579) of patients had HbA1c <7.0%. Mean semaglutide dose at EOS was 0.66 ± 0.28 mg. In the EAS, mean HbA1c and BW decreased by 1.1%-point (95% confidence interval [CI] 1.20,1.05; p<0.0001) and 4.2 kg (95% CI 4.63,3.67; p<0.0001), respectively. At EOS, 61.7% and 40.8% of patients achieved HbA1c <7.0% and <6.5%, respectively, 40.5% achieved weight loss ≥5% and 25.3% achieved the post-hoc composite endpoint. PROs improved from baseline to EOS. No new safety concerns were identified. Conclusions: In routine clinical practice in Italy, patients with T2D treated with OW semaglutide for 30 weeks achieved clinically significant improvements in HbA1c , BW and other outcomes. This article is protected by copyright. All rights reserved.