A multicenter, phase III evaluation of the efficacy and safety of a new fixed-dose pioglitazone/glimepiride combination tablet in Japanese patients with type 2 diabetes.
A multicenter, phase III evaluation of the efficacy and safety of a new fixed-dose pioglitazone/glimepiride combination tablet in Japanese patients with type 2 diabetes.
复制标题
对新型固定剂量吡格列酮/格列美脲组合片剂在日本 2 型糖尿病患者中的有效性和安全性进行多中心 III 期评估。
DOI：
10.1089/dia.2012.0246
复制
发表时间：
2013
影响因子：
5.4
通讯作者：
K. Kawakami
中科院分区：
文献类型：
--
作者：
S. Hiroi;Kenkichi Sugiura;K. Matsuno;M. Hirayama;K. Kuriyama;K. Kaku;K. Kawakami
背景
本研究旨在确定吡格列酮/格列美脲作为固定剂量组合 (FDC) 对日本 2 型糖尿病患者的疗效和安全性。
主题和方法
在这项多中心、III 期、开放标签评估中，符合条件的患者在 4 周的磨合期中途，糖化血红蛋白 (HbA(1c)) 水平必须≥7.4% 且 <10.4%，同时接受格列美脲 1 或 3mg 每日一次治疗，加上饮食和运动。基线时，根据磨合期间的格列美脲剂量，患者被分配接受为期 8 周的吡格列酮/格列美脲（15mg/1mg）FDC 每日一次（A 组；n=31）或吡格列酮/格列美脲（30mg/3mg）FDC 每日一次（B 组；n=31）治疗。
结果
吡格列酮/格列美脲使 A 组平均 HbA(1c) 水平较基线（主要终点）显着降低 0.59±0.556%（P<0.0001），B 组显着降低 0.55±0.637%（P<0.0001）。平均空腹血糖水平相应降低为12.5±21.67mg/dL（P=0.0032）和29.1±35.38mg/dL（P<0.0001）。在一个或两个治疗组中，还注意到以下参数从基线到第8周的显着变化：1,5-脱水葡萄糖醇、糖白蛋白、甘油三酯、高密度脂蛋白胆固醇和游离脂肪酸水平。 A组中有5名患者（16.1%）发生了5起治疗相关不良事件，B组有10名患者（32.3%）发生了13起此类事件；所有事件都很温和。
结论
吡格列酮/格列美脲作为 FDC（30mg/3mg 和 15mg/1mg 每日一次）可显着改善血糖控制和血脂状况，并且在日本 2 型糖尿病患者中具有良好的耐受性。
BACKGROUND
This study aimed to determine the efficacy and safety of pioglitazone/glimepiride as a fixed-dose combination (FDC) in Japanese patients with type 2 diabetes.
SUBJECTS AND METHODS
In this multicenter, phase III, open-label evaluation, eligible patients had to have a glycosylated hemoglobin (HbA(1c)) level of ≥7.4% and <10.4% halfway through a 4-week run-in period while being treated with glimepiride 1 or 3 mg once daily plus diet and exercise. At baseline, patients were assigned to 8 weeks of treatment with pioglitazone/glimepiride (15 mg/1 mg) FDC once daily (group A; n=31) or pioglitazone/glimepiride (30 mg/3 mg) FDC once daily (group B; n=31) according to their glimepiride dose during run-in.
RESULTS
Pioglitazone/glimepiride significantly reduced the mean HbA(1c) level from baseline (primary end point) by 0.59±0.556% in group A (P<0.0001) and by 0.55±0.637% in group B (P<0.0001). Corresponding reductions in the mean fasting blood glucose level were 12.5±21.67 mg/dL (P=0.0032) and 29.1±35.38 mg/dL (P<0.0001). Significant alterations from baseline to week 8 in either one or both treatment groups were also noted for the following parameters: 1,5-anhydroglucitol, glycoalbumin, triglycerides, high-density lipoprotein cholesterol, and free fatty acid levels. Five patients in group A (16.1%) had five treatment-related adverse events, and 10 patients in group B (32.3%) had 13 such events; all events were mild.
CONCLUSIONS
Pioglitazone/glimepiride as a FDC (30 mg/3 mg and 15 mg/1 mg once daily) significantly improved glycemic control and lipid profiles and was well tolerated in Japanese patients with type 2 diabetes.