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

Abstract

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 baseline 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.

Once‐weekly semaglutide use in patients with type 2 diabetes: Results from the SURE France multicentre, prospective, observational study

“…The glycaemic and body weight outcomes in SURE France were consistent with other published SURE studies, where the mean change from baseline to EOS for HbA1c ranged from –0.8% to –1.5%, and body weight from –4.2 to –7.8 kg 27‐34 . While different in design, the results of SURE France support the findings from the SUSTAIN RCTs, where change in HbA1c ranged from –1.1% to –1.8% and body weight from –3.5 to –6.5 kg 15‐23 .…”

“…Furthermore, the primary and secondary endpoint were analysed based on the EAS, excluding patients who did not complete the study on treatment. In total, 11.5% of patients discontinued semaglutide treatment, which was comparable with that observed in other SURE studies 27‐34 . A further 22.5% patients were reported as either missing the EOS visit, lost to follow‐up or withdrawn from the study.…”

“…In total, 11.5% of patients discontinued semaglutide treatment, which was comparable with that observed in other SURE studies. [27][28][29][30][31][32][33][34] A further 22.5% patients were reported as either missing the EOS visit, lost to follow-up or withdrawn from the study. These patients with unknown treatment status at EOS were a likely consequence of the severe impact of COVID-19 on the primary care service in France.…”

“…The SURE programme comprises nine non‐interventional, single‐arm, observational studies across 10 countries investigating once‐weekly semaglutide in a diverse range of patients with T2D in a real‐world setting. The aim of the programme was to complement the findings of the SUSTAIN RCTs, where semaglutide was compared with a series of comparators, and to provide a more complete understanding of once‐weekly semaglutide use in a range of clinical scenarios 27‐34 …”

“…The aim of the programme was to complement the findings of the SUSTAIN RCTs, where semaglutide was compared with a series of comparators, and to provide a more complete understanding of once-weekly semaglutide use in a range of clinical scenarios. [27][28][29][30][31][32][33][34] Here we present findings from the SURE France study, which investigated the use of once-weekly semaglutide in routine clinical practice in a real-world population of adult patients with T2D in France. As T2D duration is known to impact glycaemic response to medications, subgroups based on disease duration were also investigated.…”