Glycemic control with glyburide/metformin tablets in combination with rosiglitazone in patients with type 2 diabetes: A randomized, double-blind trial
Glycemic control with glyburide/metformin tablets in combination with rosiglitazone in patients with type 2 diabetes: A randomized, double-blind trial
复制标题
DOI：
10.1016/j.amjmed.2003.07.022
复制
发表时间：
2004-02-15
影响因子：
5.9
通讯作者：
Fiedorek, FT
中科院分区：
文献类型：
--
作者：
Dailey, GE;Noor, MA;Fiedorek, FT
目的：评估在既定格列本脲/二甲双胍方案中添加罗格列酮对血糖控制未达到适当水平（糖化血红蛋白[HbA(1C)]水平bbb7.0%，小于或等于10.0%）的2型糖尿病患者的有效性和安全性。方法：经过开放标签的引入期，优化格列本脲/二甲双胍片的剂量，365名患者随机接受包括罗格列酮（4mg，每日一次）或安慰剂的附加治疗，持续24周。根据血糖反应，维持或增加罗格列酮剂量至4mg，每日2次。维持格列本脲/二甲双胍剂量或减少2.5/ 500mg治疗症状性低血糖。主要终点是HbA（1C）水平从基线到第24周的变化。还评估了达到HbA（1C）水平< 7%和空腹血糖水平< 126 mg/dL的患者比例。结果：24周后，格列本脲/二甲双胍联合罗格列酮治疗导致HbA（1C）水平明显降低(-1.0%，P
PURPOSE: To assess the efficacy and safety of adding rosiglitazone to an established regimen of glyburide/metformin in patients with type 2 diabetes who had not achieved adequate glycemic control (glycosylated hemoglobin [HbA(1C)] levels >7.0% and less than or equal to 10.0%).METHODS: Following an open-label, lead-in phase to optimize the dosing of glyburide/metformin tablets, 365 patients randomly received additive therapy comprising rosiglitazone (4 mg once daily) or placebo for 24 weeks. Based on glycemic response, rosiglitazone dose was maintained or increased to 4 mg twice daily. Glyburide/metformin dose was maintained or reduced by 2.5/500 mg for symptomatic hypoglycemia. The primary, endpoint was the change in HbA(1C) level from baseline to week 24. The proportions of patients achieving HbA(1C) levels < 7% and a fasting plasma glucose level < 126 mg/dL were also assessed.RESULTS: After 24 weeks, therapy with glyburide/metformin plus rosiglitazone resulted in a greater reduction in HbA(1C), levels (-1.0%, P