Chien Hsin-Hsi, Chang Chwen-Tzuei, Chu Nain-Feng, Hsieh Sheng-Hwu, Huang Yu-Yao, Lee I-Te, Lee Wen-Jane, Tang Yih-Jing, Sheu Wayne H H
Division of Endocrinology and Metabolism, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Taiwan, ROC.
J Chin Med Assoc. 2007 Nov;70(11):473-80. doi: 10.1016/S1726-4901(08)70044-3.
To evaluate the efficacy and safety of glyburide/metformin combined tablet compared to glyburide or metformin alone in patients with type 2 diabetes.
In this 16-week, multicenter, randomized, double-blind, 4-arm and parallel clinical trial study, 100 patients with type 2 diabetes mellitus were recruited and 76 patients were available for statistical analysis at the end of the study. After 1 week of placebo washout period, eligible patients were randomly assigned into 1 of 4 treatment groups: glyburide 5 mg b.i.d.; metformin 500 mg b.i.d.; glyburide/metformin 2.5 mg/500 mg b.i.d.; or glyburide/metformin 5.0 mg/500 mg b.i.d. The doses were titrated every 2 weeks to a maximum of 4 tablets per day if the patients fasting plasma glucose (FPG) still exceeded 140 mg/dL. Efficacy was evaluated by the changes from baseline in glycosylated hemoglobin (HbA1c) and FPG at week 16. Adverse events were recorded and summarized by treatment group.
At week 16, patients who received glyburide/metformin 2.5 mg/500 mg or 5.0 mg/500 mg tablets had greater reductions in FPG (all p<0.001) compared with glyburide or metformin monotherapy. Patients who took glyburide/ metformin 2.5 mg/500 mg tablet and glyburide/metformin 5.0 mg/500 mg tablet had significant decreases in HbA1c (both p<0.0125). Furthermore, treatment with glyburide/metformin 2.5 mg/500 mg resulted in significantly greater reduction in HbA1c compared to glyburide or metformin (-1.77%, p<0.001 and -1.34%, p=0.002), and treatment with glyburide/metformin 5.0 mg/500 mg resulted in significant lowering of HbA1c compared to glyburide or metformin alone (-1.73%, p<0.001 and -1.30%, p=0.005). Both the glyburide/metformin 2.5 mg/500 mg and glyburide/metformin 5.0 mg/500 mg combination therapy groups experienced fewer gastrointestinal adverse events than the metformin monotherapy group.
Both glyburide/metformin 2.5 mg/500 mg and glyburide/metformin 5.0 mg/500 mg combination therapy were efficacious and well tolerated in the treatment of Chinese patients with type 2 diabetes mellitus.
评估格列本脲/二甲双胍复方片剂与单用格列本脲或二甲双胍相比，在2型糖尿病患者中的疗效和安全性。
在这项为期16周的多中心、随机、双盲、四臂平行临床试验研究中，招募了100例2型糖尿病患者，研究结束时76例患者可进行统计分析。经过1周的安慰剂洗脱期后，符合条件的患者被随机分为4个治疗组之一：格列本脲5毫克，每日两次；二甲双胍500毫克，每日两次；格列本脲/二甲双胍2.5毫克/500毫克，每日两次；或格列本脲/二甲双胍5.0毫克/500毫克，每日两次。如果患者空腹血糖（FPG）仍超过140毫克/分升，每2周调整一次剂量，最大剂量为每日4片。通过第16周糖化血红蛋白（HbA1c）和FPG相对于基线的变化评估疗效。按治疗组记录并汇总不良事件。
在第16周时，与格列本脲或二甲双胍单药治疗相比，接受格列本脲/二甲双胍2.5毫克/500毫克或5.0毫克/500毫克片剂治疗的患者FPG降低幅度更大（所有p<0.001）。服用格列本脲/二甲双胍2.5毫克/500毫克片剂和格列本脲/二甲双胍5.0毫克/500毫克片剂的患者HbA1c显著降低（均p<0.0125）。此外，与格列本脲或二甲双胍相比，格列本脲/二甲双胍2.5毫克/500毫克治疗导致HbA1c降低幅度显著更大（-1.77%，p<0.001和-1.34%，p=0.002），与单用格列本脲或二甲双胍相比，格列本脲/二甲双胍5.0毫克/500毫克治疗导致HbA1c显著降低（-1.73%，p<0.001和-1.30%，p=0.005）。格列本脲/二甲双胍2.5毫克/500毫克和格列本脲/二甲双胍5.0毫克/500毫克联合治疗组的胃肠道不良事件均少于二甲双胍单药治疗组。
格列本脲/二甲双胍2.5毫克/500毫克和格列本脲/二甲双胍5.0毫克/500毫克联合治疗在治疗中国2型糖尿病患者中疗效显著且耐受性良好。
