Division of Endocrinology and Metabolism, Department of Internal Medicine, Korea University College of Medicine, Seoul, South Korea.
Division of Endocrinology and Metabolism, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.
Diabetes Obes Metab. 2020 Oct;22(10):1869-1873. doi: 10.1111/dom.14085. Epub 2020 Jun 18.
We aimed to evaluate the efficacy and safety profile of lobeglitazone compared with sitagliptin as an add-on to metformin in patients with type 2 diabetes as well as other components of metabolic syndrome. Patients inadequately controlled by metformin were randomly assigned to lobeglitazone (0.5 mg, n = 121) or sitagliptin (100 mg, n = 126) for 24 weeks. The mean changes in HbA1c of the lobeglitazone and sitagliptin groups were -0.79% and -0.86%, respectively; the between-group difference was 0.08% (95% confidence interval, -0.14% to 0.30%), showing non-inferiority. The proportion of patients having two or more factors of other metabolic syndrome components decreased to a greater extent in the lobeglitazone group than in the sitagliptin group (-11.9% vs. -4.8%; P < .0174). Favourable changes in the lipid metabolism were also observed with lobeglitazone, which had a similar safety profile to sitagliptin. Lobeglitazone was comparable with sitagliptin as an add-on to metformin in terms of efficacy and safety.
我们旨在评估罗格列酮与西他列汀作为二甲双胍的附加疗法在 2 型糖尿病患者以及其他代谢综合征成分方面的疗效和安全性特征。未能通过二甲双胍得到充分控制的患者被随机分配至罗格列酮（0.5mg，n=121）或西他列汀（100mg，n=126）组，接受 24 周治疗。罗格列酮组和西他列汀组的 HbA1c 平均变化分别为-0.79%和-0.86%；组间差异为 0.08%（95%置信区间，-0.14%至 0.30%），显示非劣效性。与西他列汀组相比，罗格列酮组有更多的患者具有两种或更多其他代谢综合征成分的因素减少（-11.9% vs. -4.8%；P<.0174）。罗格列酮还观察到脂质代谢的有利变化，其安全性与西他列汀相似。罗格列酮在疗效和安全性方面与西他列汀作为二甲双胍的附加疗法相当。
