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 semaglutide in patients with type 2 diabetes (T2D) in routine clinical practice.Materials and Methods: Adults with T2D and >= 1 documented glycated haemoglobin (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, waist circumference and patient-reported outcomes, 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.Results: Of 579 patients who initiated semaglutide (full analysis set), 491 completed the study on treatment (EAS). Mean baseline HbA1c was 8.0%, and 20.7% (120 of 579) of patients had HbA1c < 7.0%. Mean semaglutide dose at EOS was 0.66 +/- 0.28 mg. In the EAS, mean HbA1c and body weight decreased by 1.1%-point (95% confidence interval 1.20, 1.05; P < .0001) and 4.2 kg (95% confidence interval 4.63, 3.67; P < .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. Patient-reported outcomes improved from base -line to EOS. No new safety concerns were identified.Conclusions: In routine clinical practice in Italy, patients with T2D treated with once-weekly semaglutide for 30 weeks achieved clinically significant improvements in HbA1c, body weight and other outcomes.