INSERM, BMC, Université de Bordeaux, Pessac, France.
Novo Nordisk, Paris, France.
Diabetes Obes Metab. 2023 Jul;25(7):1855-1864. doi: 10.1111/dom.15045. Epub 2023 Mar 28.
Real-world data are required to support glucagon-like peptide-1 receptor agonist use in type 2 diabetes (T2D). SURE France assessed once-weekly semaglutide in adults with T2D in real-world clinical practice.
This multicentre, prospective, open-label, single-arm study included adults with T2D and ≥1 documented glycated haemoglobin (HbA1c) value ≤12 weeks before semaglutide initiation. The primary endpoint was HbA1c change from baseline to end of study (EOS; ~30 weeks). Secondary endpoints included change from baseline to EOS in body weight (BW) and waist circumference (WC); and proportion achieving HbA1c targets. Baseline characteristics and safety were reported for the full analysis set (patients initiating semaglutide). Analysis of other endpoints was based on the effectiveness analysis set (study completers receiving semaglutide at EOS).
Of 497 patients initiating semaglutide (41.6% female, mean age 58.3 years), 348 completed the study on treatment. Baseline HbA1c, diabetes duration, BW and WC, were 8.3%, 10.0 years, 98.2 kg and 114.2 cm, respectively. The most common reasons for initiating semaglutide were to improve glycaemic control (79.7%), reduce BW (69.8%) and address cardiovascular risk (24.1%). At EOS, mean changes were: HbA1c, -1.2% points [95% confidence interval (CI) -1.32; -1.10]; BW, -4.7 kg (95% CI -5.38; -4.07); and WC, -4.9 cm (95% CI -5.94; -3.88). At EOS, 81.7%, 67.7% and 51.6% of patients achieved an HbA1c target of <8.0%, <7.5% and <7.0%, respectively. No new safety concerns were identified.
These results support the benefits of semaglutide in a real-world setting in adults with T2D in France showing a significant reduction in HbA1c and body weight.
需要真实世界的数据来支持胰高血糖素样肽-1 受体激动剂在 2 型糖尿病(T2D)中的应用。法国 SURE 研究评估了每周一次的司美格鲁肽在真实临床实践中用于 T2D 成人患者的疗效。
这是一项多中心、前瞻性、开放标签、单臂研究,纳入了 T2D 成人患者,这些患者在开始司美格鲁肽治疗前有≥1 次糖化血红蛋白(HbA1c)记录值≤12 周。主要终点为从基线到研究结束(EOS;约 30 周)时 HbA1c 的变化。次要终点包括从基线到 EOS 时体重(BW)和腰围(WC)的变化;以及达到 HbA1c 目标的比例。报告了全分析集(开始使用司美格鲁肽的患者)的基线特征和安全性。其他终点的分析基于有效性分析集(EOS 时接受司美格鲁肽治疗的研究完成者)。
497 例开始使用司美格鲁肽的患者中(41.6%为女性,平均年龄 58.3 岁),348 例完成了研究治疗。基线时的 HbA1c、糖尿病病程、BW 和 WC 分别为 8.3%、10.0 年、98.2kg 和 114.2cm。开始使用司美格鲁肽的最常见原因是改善血糖控制(79.7%)、降低 BW(69.8%)和解决心血管风险(24.1%)。EOS 时,平均变化为:HbA1c,-1.2%点[95%置信区间(CI)-1.32;-1.10];BW,-4.7kg(95%CI-5.38;-4.07);WC,-4.9cm(95%CI-5.94;-3.88)。EOS 时,81.7%、67.7%和 51.6%的患者分别达到 HbA1c 目标<8.0%、<7.5%和<7.0%。未发现新的安全性问题。
这些结果支持了司美格鲁肽在法国真实环境中用于 T2D 成人患者的疗效,表明 HbA1c 和体重有显著降低。