Goldenberg Ronald, Gantz Ira, Andryuk Paula J, O'Neill Edward A, Kaufman Keith D, Lai Eseng, Wang Yin Na, Suryawanshi Shailaja, Engel Samuel S
LMC Diabetes & Endocrinology, Toronto, Ontario, Canada.
Merck & Co., Inc., Kenilworth, New Jersey.
Diabetes Obes Metab. 2017 Mar;19(3):394-400. doi: 10.1111/dom.12832. Epub 2017 Jan 17.
To compare the efficacy and safety of the once-weekly oral dipeptidyl peptidase-4 (DPP-4) inhibitor omarigliptin or once-daily DPP-4 inhibitor sitagliptin in patients with type 2 diabetes (T2DM) and inadequate glycaemic control on metformin.
Patients with T2DM with a glycated haemoglobin (HbA1c) concentration ≥6.5% to ≤9.0% while on a stable dose of metformin (≥1500 mg/d) were randomized in a double-blind manner to receive omarigliptin 25 mg once weekly (n = 322) or sitagliptin 100 mg once daily (n = 320). The primary analysis assessed whether omarigliptin was non-inferior to sitagliptin in reducing HbA1c at week 24, based on the criterion of having an upper bound of the 95% confidence interval (CI) about the difference less than the non-inferiority bound of 0.3%.
The mean baseline HbA1c was 7.5% in both groups. After 24 weeks, the least squares (LS) mean change in HbA1c from baseline was -0.47% in the omarigliptin group and -0.43% in the sitagliptin group, with a between-group difference of -0.03% (95% CI -0.15, 0.08). This result met the prespecified criterion for declaring non-inferiority. The LS mean change from baseline in fasting plasma glucose and the percentage of patients with HbA1c <7.0% or <6.5% at week 24 were similar in the two treatment groups. There were no notable differences in adverse events and the incidence of symptomatic hypoglycaemia was low and similar in the groups.
In patients with T2DM and inadequate glycaemic control on metformin, the addition of omarigliptin 25 mg once weekly or sitagliptin 100 mg once daily led to similar improvements in glycaemic control. Both agents were generally well tolerated with a low incidence of hypoglycaemia.
比较每周一次口服二肽基肽酶-4（DPP-4）抑制剂奥格列汀与每日一次DPP-4抑制剂西格列汀对二甲双胍治疗血糖控制不佳的2型糖尿病（T2DM）患者的疗效和安全性。
糖化血红蛋白（HbA1c）浓度≥6.5%至≤9.0%且正在接受稳定剂量二甲双胍（≥1500mg/d）治疗的T2DM患者，以双盲方式随机分组，接受每周一次25mg奥格列汀治疗（n = 322）或每日一次100mg西格列汀治疗（n = 320）。主要分析基于95%置信区间（CI）差值的上限小于非劣效界值0.3%的标准，评估第24周时奥格列汀在降低HbA1c方面是否不劣于西格列汀。
两组的平均基线HbA1c均为7.5%。24周后，奥格列汀组HbA1c自基线的最小二乘（LS）平均变化为-0.47%，西格列汀组为-0.43%，组间差异为-0.03%（95%CI -0.15，0.08）。该结果符合预先设定的非劣效性标准。两个治疗组在空腹血糖自基线的LS平均变化以及第24周时HbA1c<7.0%或<6.5%的患者百分比方面相似。不良事件无显著差异，且有症状低血糖的发生率较低，两组相似。
对于二甲双胍治疗血糖控制不佳的T2DM患者，每周一次添加25mg奥格列汀或每日一次添加100mg西格列汀在血糖控制方面带来相似的改善。两种药物总体耐受性良好，低血糖发生率较低。
