Efficacy and safety of alogliptin added to metformin in Japanese patients with type 2 diabetes: a randomized, double-blind, placebo-controlled trial with an open-label, long-term extension study
Efficacy and safety of alogliptin added to metformin in Japanese patients with type 2 diabetes: a randomized, double-blind, placebo-controlled trial with an open-label, long-term extension study
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DOI：
10.1111/j.1463-1326.2012.01620.x
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发表时间：
2012-10-01
影响因子：
5.8
通讯作者：
Kaku, K.
中科院分区：
文献类型：
--
作者：
Seino, Y.;Miyata, Y.;Kaku, K.
目的：在二甲双胍治疗血糖控制不佳的日本2型糖尿病患者中，评价阿格列汀加用二甲双胍与二甲双胍单药治疗的疗效和安全性（500或750毫克/天）+饮食/运动。方法：在一项随机双盲试验中，288例2型糖尿病T2 DM患者接受12.5或25 mg阿格列汀每日一次+二甲双胍或安慰剂+二甲双胍治疗12周。此后，276例患者继续接受两种阿格列汀剂量之一+二甲双胍的开放标签扩展治疗40周。随机化、双盲期的主要疗效终点为HbA 1c自基线（第0周）至治疗结束（第12周）的变化。结果：12周后，阿格列汀+二甲双胍两种剂量的HbA 1c较基线的变化均显著大于安慰剂（二甲双胍单药治疗：LS均值变化分别为-0.55和-0.64% vs. 0.22%; p
Aims: To evaluate the efficacy and safety of alogliptin added to metformin versus metformin monotherapy in Japanese patients with type 2 diabetes who achieved inadequate glycaemic control on metformin (500 or 750 mg/day) + diet/exercise.Methods: In a randomized, double-blind trial, 288 patients with type 2 diabetes mellitus T2DM received either 12.5 or 25mg alogliptin once daily + metformin or placebo + metformin for 12 weeks. Thereafter, 276 patients continued on one of the two alogliptin dosages + metformin in an open-label extension for 40 weeks. The primary efficacy endpoint in the randomized, double-blind phase was the change in HbA1c from baseline (week 0) to the end of treatment (week 12). The primary endpoint during the long-term extension phase was adverse events.Results: After 12 weeks both dosages of alogliptin + metformin produced significantly greater changes from baseline in HbA1c than placebo (metformin monotherapy: with changes in LS means -0.55 and -0.64% vs. 0.22%, respectively; p