Endocr Pract. 2019 Jun;25(6):589-597. doi: 10.4158/EP-2018-0444. Epub 2019 Mar 13.
Semaglutide is a glucagon-like peptide 1 (GLP-1) analog for the once-weekly treatment of type 2 diabetes (T2D). In the global SUSTAIN clinical trial program, semaglutide demonstrated superior glycated hemoglobin (HbA) and body weight reductions versus comparators. This post hoc analysis compared the proportion of patients achieving combined reductions in glycemia and body weight versus comparators. A total of 5,119 subjects with T2D in the phase 3 SUSTAIN 1 through 5 and 7 trials, from 33 countries, were included in this post hoc analysis. Subjects received subcutaneous semaglutide 0.5 or 1.0 mg, placebo or active comparator (sitagliptin 100 mg, exenatide extended release 2.0 mg, insulin glargine, dulaglutide 0.75 or 1.5 mg). The main endpoint was a composite of ≥1.0% HbA reduction and ≥5.0% weight loss at end of treatment. Significantly greater proportions of subjects achieved the composite endpoint with semaglutide 0.5 (25 to 38%) and 1.0 mg (38 to 59%) versus comparators (2 to 23%). More subjects treated with semaglutide versus comparators achieved ≥1.0% HbA reductions (58 to 77% and 75 to 83% for semaglutide 0.5 and 1.0 mg versus 12 to 68%) and ≥5.0% weight loss (37 to 46%, 45 to 66% versus 4 to 30%). Proportions of subjects achieving targets were significantly higher with semaglutide 1.0 versus 0.5 mg in four of five trials. Semaglutide was well tolerated, with a safety profile similar to other GLP-1 receptor agonists. Significantly more subjects achieved both ≥1.0% HbA reduction and ≥5.0% weight loss with once-weekly subcutaneous semaglutide treatment versus comparators in the SUSTAIN trials. A dose-dependent effect was observed with semaglutide. = adverse event; = cardiovascular; = extended release; = glucagon-like peptide 1; = glucagon-like peptide 1 receptor agonist; = glycated hemoglobin; = oral antidiabetic drug; = subcutaneous; = type 2 diabetes.
司美格鲁肽是一种胰高血糖素样肽 1(GLP-1)类似物,每周给药一次,用于治疗 2 型糖尿病(T2D)。在全球 SUSTAIN 临床试验项目中,司美格鲁肽在糖化血红蛋白(HbA)和体重降低方面优于对照药物。本事后分析比较了与对照药物相比,同时实现血糖和体重降低的患者比例。 在来自 33 个国家的 3 期 SUSTAIN 1 至 5 期和 7 期临床试验中,共纳入 5119 例 T2D 患者,进行本事后分析。受试者接受皮下注射司美格鲁肽 0.5 或 1.0mg、安慰剂或活性对照药物(西格列汀 100mg、艾塞那肽延长释放剂 2.0mg、甘精胰岛素、度拉糖肽 0.75 或 1.5mg)。主要终点是治疗结束时 HbA 降低≥1.0%和体重减轻≥5.0%的复合终点。 与对照药物相比,司美格鲁肽 0.5mg(25%至 38%)和 1.0mg(38%至 59%)的患者中,达到复合终点的比例显著更高(2%至 23%)。与对照药物相比,更多接受司美格鲁肽治疗的患者达到 HbA 降低≥1.0%(司美格鲁肽 0.5 和 1.0mg 为 58%至 77%和 75%至 83%,而对照药物为 12%至 68%)和体重减轻≥5.0%(司美格鲁肽 0.5 和 1.0mg 为 37%至 46%和 45%至 66%,而对照药物为 4%至 30%)。在五项试验中的四项中,司美格鲁肽 1.0mg 组达到目标的患者比例明显高于司美格鲁肽 0.5mg 组。 司美格鲁肽耐受性良好,安全性与其他 GLP-1 受体激动剂相似。 在 SUSTAIN 试验中,每周一次皮下注射司美格鲁肽治疗与对照药物相比,显著更多患者同时实现 HbA 降低≥1.0%和体重减轻≥5.0%。司美格鲁肽呈剂量依赖性。 = 不良反应;= 心血管;= 延长释放;= 胰高血糖素样肽 1;= 胰高血糖素样肽 1 受体激动剂;= 糖化血红蛋白;= 口服抗糖尿病药物;= 皮下;= 2 型糖尿病。