Efficacy and safety of a single-pill combination of vildagliptin and metformin in Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled trial.
Efficacy and safety of a single-pill combination of vildagliptin and metformin in Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled trial.
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DOI：
10.1007/s13300-015-0099-x
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发表时间：
2015-03
期刊：
影响因子：
3.8
通讯作者：
Kothny, Wolfgang
中科院分区：
文献类型：
--
作者：
Odawara, Masato;Yoshiki, Mika;Sano, Misako;Hamada, Izumi;Lukashevich, Valentina;Kothny, Wolfgang
关键词：
在日本 2 型糖尿病 (T2DM) 患者中，二肽基肽酶 4 抑制剂与二甲双胍联合使用的情况越来越多，但日本目前尚无单药联合用药 (SPC)。本研究的目的是评估维格列汀/二甲双胍 SPC 对维格列汀单药治疗未充分控制的日本 T2DM 患者的疗效和安全性。这是一项为期 14 周的随机、双盲、平行组、安慰剂对照试验。 171 名接受维格列汀 50 mg 每日两次（每日两次）控制不佳的 T2DM 患者 [HbA1c（糖化血红蛋白）7.0–10.0%] 被随机 (2:1) 接受维格列汀/二甲双胍 SPC (n = 115) 或匹配的维格列汀/安慰剂 SPC (n = 56)。治疗组之间的基线人口统计数据和背景特征通常具有可比性。维格列汀/二甲双胍 SPC（基线 HbA1c，7.9 ± 0.1%）组的 HbA1c 变化[平均值±标准误差 (SE)] 为 -0.8 ± 0.1%，维格列汀/安慰剂 SPC（基线 HbA1c，8.0 ± 0.1%）组的 HbA1c 变化为 0.1 ± 0.1%，其中维格列汀/二甲双胍 SPC 组的治疗间差异为 -1.0 ± 0.1% (P <0.001)。与维格列汀/安慰剂 SPC 相比，维格列汀/二甲双胍 SPC 实现 HbA1c 目标 <7.0% 的患者比例显着更高（45.8% vs. 13.5%，P <0.001）。维格列汀/二甲双胍 SPC 组的不良事件 (AE) 总体发生率为 43.5%，维格列汀/安慰剂 SPC 组为 67.9%。两个治疗组的严重 AE 发生率均较低（分别为 0.9% 和 3.6%）。在整个研究过程中，两个治疗组的体重均保持恒定。研究期间没有死亡或低血糖事件。将需要强化治疗的日本 T2DM 患者从维格列汀单药治疗转为维格列汀/二甲双胍 SPC（50/250 或 50/500 mg）是有效且安全的，可显着降低 HbA1c，且不会增加低血糖和体重增加的风险。本文的在线版本 (doi:10.1007/s13300-015-0099-x) 包含补充材料，可供授权用户使用。
The use of dipeptidyl peptidase-4 inhibitors in combination with metformin is increasing in Japanese patients with type 2 diabetes mellitus (T2DM), but no single-pill combination (SPC) is currently available in Japan. The objective of this study was to assess the efficacy and safety of vildagliptin/metformin SPC in Japanese patients with T2DM inadequately controlled with vildagliptin monotherapy. This was a 14-week, randomized, double-blind, parallel-group, placebo-controlled trial. 171 patients with T2DM inadequately controlled [HbA1c (glycosylated hemoglobin) 7.0–10.0%] with vildagliptin 50 mg twice daily (bid) were randomized (2:1) to receive either a vildagliptin/metformin SPC (n = 115) or matching vildagliptin/placebo SPC (n = 56). Baseline demographics and background characteristics were generally comparable between the treatment groups. The change in HbA1c [mean ± standard error (SE)] was −0.8 ± 0.1% in the vildagliptin/metformin SPC (baseline HbA1c, 7.9 ± 0.1%) group and 0.1 ± 0.1% in the vildagliptin/placebo SPC (baseline HbA1c, 8.0 ± 0.1%) group, with a between-treatment difference of −1.0 ± 0.1% (P <0.001) in favor of the vildagliptin/metformin SPC group. The proportion of patients achieving target HbA1c <7.0% was significantly higher with vildagliptin/metformin SPC compared with vildagliptin/placebo SPC (45.8% vs. 13.5%, P <0.001). The overall incidences of adverse events (AEs) were 43.5% in the vildagliptin/metformin SPC and 67.9% in the vildagliptin/placebo SPC group. The incidences of serious AEs were low in both the treatment groups (0.9% vs. 3.6%, respectively). Body weight remained constant throughout the study in both the treatment groups. There were no deaths or hypoglycemic events during the study. Switching Japanese patients with T2DM requiring treatment intensification, from vildagliptin monotherapy to a vildagliptin/metformin SPC (50/250 or 50/500 mg) was efficacious and safe, eliciting significant reduction in HbA1c without increased risk of hypoglycemia and weight gain. The online version of this article (doi:10.1007/s13300-015-0099-x) contains supplementary material, which is available to authorized users.
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