Peking University People's Hospital No. 11, Beijing, China.
Jinan Central Hospital, Affiliated to Shandong University No. 105, Jinan, China.
Diabetes Obes Metab. 2021 Feb;23(2):404-414. doi: 10.1111/dom.14232. Epub 2021 Jan 3.
To evaluate the efficacy and safety of once-weekly subcutaneous semaglutide, a glucagon-like peptide-1 (GLP-1) analogue, versus once-daily sitagliptin as add-on to metformin in patients with type 2 diabetes (T2D) in a multiregional clinical trial.
In the 30-week, randomized, double-blind, double-dummy, active comparator SUSTAIN China trial, 868 adults with T2D inadequately controlled on metformin (HbA1c 7.0%-10.5%) were randomized to receive once-weekly semaglutide 0.5 mg (n = 288), semaglutide 1.0 mg (n = 290) or once-daily sitagliptin 100 mg (n = 290). The primary and confirmatory secondary endpoints were change from baseline to week 30 in HbA and body weight, respectively.
The trial enrolled ~70% (605/868) of the patients in China, and the remaining patients from four other countries, including the Republic of Korea. Both doses of semaglutide were superior to sitagliptin in reducing HbA and body weight after 30 weeks of treatment. The odds of achieving target HbA of less than 7.0% (53 mmol/mol), weight loss of 5% or higher, or 10% or higher, and the composite endpoint of HbA less than 7.0% (53 mmol/mol) without severe or blood glucose-confirmed symptomatic hypoglycaemia no weight gain, were all significantly higher with both semaglutide doses compared with sitagliptin. The safety profile for semaglutide was consistent with the known class effects of GLP-1 receptor agonists (RAs). Consistent efficacy and safety findings were seen in the Chinese subpopulation.
Once-weekly semaglutide was superior to sitagliptin in improving glycaemic control and reducing body weight in patients with T2D inadequately controlled on metformin. The safety and tolerability profiles were consistent with those of semaglutide and other GLP-1 RAs. Semaglutide is an effective once-weekly treatment option for the Chinese population.
评估每周一次皮下注射司美格鲁肽（一种胰高血糖素样肽-1[GLP-1]类似物）与每日一次西格列汀作为二甲双胍添加治疗 2 型糖尿病（T2D）患者的疗效和安全性，这是一项多区域临床试验。
在 30 周、随机、双盲、双模拟、阳性对照的 SUSTAIN China 试验中，868 例二甲双胍控制不佳的 T2D 患者（HbA1c7.0%-10.5%）被随机分为每周一次司美格鲁肽 0.5mg（n=288）、司美格鲁肽 1.0mg（n=290）或每日一次西格列汀 100mg（n=290）组。主要和确认性次要终点分别为治疗 30 周时与基线相比 HbA1c 和体重的变化。
该试验在中国招募了约 70%（605/868）的患者，其余患者来自包括韩国在内的其他四个国家。两种剂量的司美格鲁肽在治疗 30 周后均优于西格列汀，可降低 HbA1c 和体重。实现 HbA1c<7.0%（53mmol/mol）、体重减轻 5%或更高、或 10%或更高，以及 HbA1c<7.0%（53mmol/mol）无严重或血糖确认的症状性低血糖、无体重增加的复合终点的可能性，与西格列汀相比，两种剂量的司美格鲁肽均显著更高。司美格鲁肽的安全性与 GLP-1 受体激动剂（RAs）的已知类别效应一致。在中国亚人群中观察到一致的疗效和安全性结果。
每周一次司美格鲁肽在改善血糖控制和减轻二甲双胍控制不佳的 T2D 患者体重方面优于西格列汀。安全性和耐受性特征与司美格鲁肽和其他 GLP-1 RAs 一致。司美格鲁肽是中国人群有效的每周一次治疗选择。
