Randomized clinical trial comparing the efficacy and safety of treatment with the once-weekly dipeptidyl peptidase-4 (DPP-4) inhibitor omarigliptin or the once-daily DPP-4 inhibitor sitagliptin in patients with type 2 diabetes inadequately controlled on metformin monotherapy.
Randomized clinical trial comparing the efficacy and safety of treatment with the once-weekly dipeptidyl peptidase-4 (DPP-4) inhibitor omarigliptin or the once-daily DPP-4 inhibitor sitagliptin in patients with type 2 diabetes inadequately controlled on metformin monotherapy.
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DOI：
10.1111/dom.12832
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发表时间：
2017-03
期刊：
影响因子：
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通讯作者：
Engel SS
中科院分区：
文献类型：
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作者：
Goldenberg R;Gantz I;Andryuk PJ;O'Neill EA;Kaufman KD;Lai E;Wang YN;Suryawanshi S;Engel SS
比较每周口服一次DPP-4(DPP-4)抑制剂奥马力格列汀或每日口服一次DPP-4抑制剂西格列汀(Sitagliptin)对血糖控制不佳的2型糖尿病(T2 DM)患者的疗效和安全性。糖化血红蛋白(HbA1c)浓度为≥6.5%~≤9.0%，同时服用稳定剂量二甲双胍(≥1500 mg/d)的T2 DM患者随机双盲，每周服用一次奥马利汀25 mg(n=322)或西格列汀100 mg每日一次(n=320)。初步分析评估了24周时奥马利普汀在降低HbA1c方面是否不逊于西格列汀，标准是关于差异的95%可信区间(CI)上界小于0.3%的非劣势区间。两组的平均基线HbA1c均为7.5%。24周后，奥马利汀组和西格列汀组HbA1c较基线的最小二乘(LS)平均变化分别为−0.47%和−0.43%，组间差异−0.03%(95%CI−0.15，0.08)。这一结果符合宣布非自卑的预先指定的标准。两个治疗组的LS平均空腹血糖变化以及24周时HbA1c和HbA1c及HbA1c和HbA1c及HbA1c和HbA1c分别为7.0%和6.5%的患者的百分比相似。两组不良事件无显著差异，症状性低血糖发生率低且相似。在2型糖尿病和二甲双胍血糖控制不足的患者中，每周服用一次奥马利普汀25毫克或每天服用一次西格列汀100毫克，在血糖控制方面也有类似的改善。两种药物总体耐受性良好，低血糖发生率较低。
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.