A randomized, placebo- and sitagliptin-controlled trial of the safety and efficacy of omarigliptin, a once-weekly dipeptidyl peptidase-4 inhibitor, in Japanese patients with type 2 diabetes.
A randomized, placebo- and sitagliptin-controlled trial of the safety and efficacy of omarigliptin, a once-weekly dipeptidyl peptidase-4 inhibitor, in Japanese patients with type 2 diabetes.
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DOI：
10.1111/dom.12988
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发表时间：
2017-11
期刊：
影响因子：
--
通讯作者：
the Omarigliptin Study 020 Group
中科院分区：
文献类型：
--
作者：
Gantz I;Okamoto T;Ito Y;Okuyama K;O'Neill EA;Kaufman KD;Engel SS;Lai E;the Omarigliptin Study 020 Group
评估奥格列汀在日本 2 型糖尿病 (T2D) 患者中的安全性和有效性。在一项为期 24 周的双盲试验中，414 名 T2D 患者被随机分配至奥格列汀 25 mg 每周一次、西格列汀 50 mg 每日一次或安慰剂组。双盲期之后是 28 周的开放标签延长期，在此期间所有患者每周接受一次 25 mg 奥格列汀治疗。疗效终点为糖化血红蛋白 (HbA1c)、餐后 2 小时血糖 (PPG) 和空腹血糖 (FPG) 水平。 24 周后，HbA1c 相对于基线的最小二乘 (LS) 平均变化为：奥格列汀为 -0.66%，西格列汀为 -0.65%，安慰剂为 0.13%。奥格列汀与安慰剂的 LS 平均值差异为 -0.80% (P < .001)。奥格列汀与西他列汀的 LS 平均值差异为 -0.02%（95% 置信区间 -0.15, 0.12），符合非劣效于西他列汀的标准。与安慰剂相比，两种积极治疗均显着降低了 FPG 和 2 小时 PPG (P < .001)。在 24 周的双盲期内，治疗组之间的不良事件发生率没有临床意义的差异。西格列汀组出现 1 次症状性低血糖，而奥格列汀组或安慰剂组则没有出现这一情况。在 28 周的开放标签期中，与双盲期相比，奥格列汀持续改善血糖控制，且安全性没有显着变化。奥格列汀对体重没有显着影响。在日本 2 型糖尿病患者中，与安慰剂相比，每周一次 25mg 奥格列汀可显着降低血糖，并且不劣于每天一次 50mg 西他列汀。奥格列汀通常耐受性良好，可持续长达 52 周。
To assess the safety and efficacy of omarigliptin in Japanese patients with type 2 diabetes (T2D). In a 24‐week double‐blind trial, 414 patients with T2D were randomized to omarigliptin 25 mg once weekly, sitagliptin 50 mg once daily or placebo. The double‐blind period was followed by a 28‐week open‐label extension during which all patients received omarigliptin 25 mg once weekly. Efficacy endpoints were glycated haemoglobin (HbA1c), 2‐hour postprandial glucose (PPG) and fasting plasma glucose (FPG) levels. After 24 weeks, the least squares (LS) mean change from baseline in HbA1c was −0.66% for omarigliptin, −0.65% for sitagliptin and 0.13% for placebo. The difference in LS mean for omarigliptin vs placebo was −0.80% (P < .001). The difference in LS mean for omarigliptin vs sitagliptin was −0.02% (95% confidence interval −0.15, 0.12), which met the criterion for non‐inferiority to sitagliptin. Both active treatments provided significant reductions in FPG and 2‐hour PPG compared with placebo (P < .001). Over the 24‐week double‐blind period, there were no clinically meaningful differences in the incidence rates of adverse events among the treatment groups. There was 1 episode of symptomatic hypoglycaemia in the sitagliptin group and none in the omarigliptin or placebo groups. In the 28‐week open‐label period, omarigliptin provided persistent improvements in glycaemic control without notable change in safety profile compared with the double‐blind period. Omarigliptin had no meaningful effect on body weight. In Japanese patients with T2D, omarigliptin 25 mg once weekly provided significant glucose‐lowering compared with placebo and was non‐inferior to sitagliptin 50 mg once daily. Omarigliptin was generally well tolerated for up to 52 weeks.
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作者：
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