Kansai Electric Power Medical Research Institute, Kobe, Japan.
Kansai Electric Power Hospital, Osaka, Japan.
Diabetes Obes Metab. 2018 Feb;20(2):378-388. doi: 10.1111/dom.13082. Epub 2017 Oct 5.
To assess the safety and efficacy of monotherapy with once-weekly subcutaneous (s.c.) semaglutide vs sitagliptin in Japanese people with type 2 diabetes (T2D).
In this phase IIIa randomized, open-label, parallel-group, active-controlled, multicentre trial, Japanese adults with T2D treated with diet and exercise only or oral antidiabetic drug monotherapy (washed out during the run-in period) received once-weekly s.c. semaglutide (0.5 or 1.0 mg) or once-daily oral sitagliptin 100 mg. The primary endpoint was number of treatment-emergent adverse events (TEAEs) after 30 weeks.
Overall, 308 participants were randomized and exposed to treatment, with similar baseline characteristics across the groups. In total, 2.9% of participants in both the semaglutide 0.5 mg and the sitagliptin group prematurely discontinued treatment, compared with 14.7% in the semaglutide 1.0 mg group. The majority of discontinuations in the semaglutide 0.5 and 1.0 mg groups were attributable to adverse events (AEs). More TEAEs were reported in semaglutide- vs sitagliptin-treated participants (74.8%, 71.6% and 66.0% in the semaglutide 0.5 mg, semaglutide 1.0 mg and sitagliptin groups, respectively). AEs were mainly mild to moderate. Gastrointestinal AEs, most frequently reported with semaglutide, diminished in frequency over time. The mean glycated haemoglobin (HbA1c [baseline 8.1%]) decreased by 1.9% and 2.2% with semaglutide 0.5 and 1.0 mg, respectively, vs 0.7% with sitagliptin (estimated treatment difference [ETD] vs sitagliptin -1.13%, 95% confidence interval [CI] -1.32; -0.94, and -1.44%, 95% CI -1.63; -1.24; both P < .0001). Body weight (baseline 69.3 kg) was reduced by 2.2 and 3.9 kg with semaglutide 0.5 and 1.0 mg, respectively (ETD -2.22 kg, 95% CI -3.02; -1.42 and -3.88 kg, 95% CI -4.70; -3.07; both P < .0001).
In Japanese people with T2D, more TEAEs were reported with semaglutide than with sitagliptin; however, the semaglutide safety profile was similar to that of other glucagon-like peptide-1 receptor agonists. Semaglutide significantly reduced HbA1c and body weight compared with sitagliptin.
评估每周一次皮下注射（sc）司美格鲁肽与西格列汀单药治疗在日本 2 型糖尿病（T2D）患者中的安全性和疗效。
在这项 IIIa 期随机、开放标签、平行组、阳性对照、多中心试验中，接受饮食和运动治疗或口服降糖药单药治疗（在导入期洗脱）的日本 T2D 成年患者接受每周一次 sc 司美格鲁肽（0.5 或 1.0mg）或每日一次口服西格列汀 100mg。主要终点为 30 周后治疗出现的不良事件（TEAEs）的数量。
共有 308 名参与者被随机分配并接受治疗，各组之间具有相似的基线特征。司美格鲁肽 0.5mg 和西格列汀组各有 2.9%的参与者提前停止治疗，而司美格鲁肽 1.0mg 组有 14.7%的参与者提前停止治疗。司美格鲁肽 0.5 和 1.0mg 组大多数停药归因于不良事件（AE）。与西格列汀组相比，司美格鲁肽组报告了更多的 TEAEs（司美格鲁肽 0.5mg、1.0mg 和西格列汀组分别为 74.8%、71.6%和 66.0%）。AE 主要为轻度至中度。最常报告的胃肠道 AE 随着时间的推移频率降低。糖化血红蛋白（HbA1c[基线 8.1%]）分别下降 1.9%和 2.2%，司美格鲁肽 0.5mg 和 1.0mg 组分别下降 0.7%，西格列汀组（与西格列汀的估计治疗差异[ETD] -1.13%，95%置信区间[CI] -1.32；-0.94，和 -1.44%，95%CI -1.63；-1.24；均 P<0.0001）。体重（基线 69.3kg）分别减轻 2.2kg 和 3.9kg，司美格鲁肽 0.5mg 和 1.0mg 组（ETD -2.22kg，95%CI -3.02；-1.42 和 -3.88kg，95%CI -4.70；-3.07；均 P<0.0001）。
在日本 T2D 患者中，司美格鲁肽组报告的 TEAEs 多于西格列汀组；然而，司美格鲁肽的安全性与其他胰高血糖素样肽-1 受体激动剂相似。与西格列汀相比，司美格鲁肽显著降低 HbA1c 和体重。
