Garber A, Klein E, Bruce S, Sankoh S, Mohideen P
Department of Medicine, Baylor College of Medicine, Houston, TX, USA.
Diabetes Obes Metab. 2006 Mar;8(2):156-63. doi: 10.1111/j.1463-1326.2005.00570.x.
This double-blind study evaluated the efficacy and safety of metformin-glibenclamide tablets vs. metformin plus rosiglitazone therapy in patients with type 2 diabetes inadequately controlled on metformin monotherapy.
After an open-label, metformin lead-in phase, 318 patients were randomly assigned to treatment based on metformin-glibenclamide 500/2.5 mg tablets (initial daily dose 1000/5 mg) or metformin 500 mg plus rosiglitazone 4 mg (initial daily dose 1000-2000 mg + 4 mg, depending on previous treatment) for 24 weeks. Doses were titrated to achieve the therapeutic glycaemic target. The primary efficacy variable was the change in HbA1C.
At week 24, metformin-glibenclamide tablets resulted in significantly greater reductions in HbA1C (-1.5%) and fasting plasma glucose [-2.6 mmol/l (-46 mg/dl)] than metformin plus rosiglitazone [-1.1%, p < 0.001; -2 mmol/l (-36 mg/dl), p = 0.03]. More patients receiving metformin-glibenclamide attained HbA1C <7.0% than did those in the metformin plus rosiglitazone group (60 vs. 47%) and had fasting plasma glucose levels <7 mmol/l (<126 mg/dl) by week 24 (34 vs. 25%). Both treatments were well tolerated. Frequency of adverse gastrointestinal events was comparable between groups. Four per cent of patients receiving metformin-glibenclamide withdrew because of symptomatic hypoglycaemia contrasted with 3% of patients receiving metformin plus rosiglitazone who withdrew because of persistent hyperglycaemia. Hypoglycaemic events were mild or moderate in intensity and were easily self-managed.
Metformin-glibenclamide tablets resulted in significantly greater reductions in HbA1C and fasting plasma glucose compared with metformin plus rosiglitazone in patients with type 2 diabetes inadequately controlled on metformin monotherapy.
本双盲研究评估了二甲双胍格列本脲片与二甲双胍联合罗格列酮治疗对二甲双胍单药治疗控制不佳的2型糖尿病患者的疗效和安全性。
在开放标签的二甲双胍导入期后，318例患者被随机分配接受基于二甲双胍格列本脲500/2.5毫克片剂（初始日剂量1000/5毫克）或二甲双胍500毫克加罗格列酮4毫克（初始日剂量1000 - 2000毫克 + 4毫克，取决于先前治疗情况）的治疗，为期24周。剂量进行滴定以实现治疗性血糖目标。主要疗效变量为糖化血红蛋白（HbA1C）的变化。
在第24周时，二甲双胍格列本脲片使HbA1C（-1.5%）和空腹血糖[ -2.6毫摩尔/升（-46毫克/分升）]的降低幅度显著大于二甲双胍联合罗格列酮[ -1.1%，p < 0.001；-2毫摩尔/升（-36毫克/分升），p = 0.03]。到第24周时，接受二甲双胍格列本脲治疗的患者中达到HbA1C <7.0%的比例高于二甲双胍联合罗格列酮组（60%对47%），且空腹血糖水平<7毫摩尔/升（<126毫克/分升）的比例也更高（34%对25%）。两种治疗的耐受性均良好。两组间不良胃肠道事件的发生率相当。接受二甲双胍格列本脲治疗的患者中有4%因症状性低血糖而退出，相比之下，接受二甲双胍联合罗格列酮治疗的患者中有3%因持续性高血糖而退出。低血糖事件的强度为轻度或中度，且易于自我处理。
对于二甲双胍单药治疗控制不佳的2型糖尿病患者，二甲双胍格列本脲片相比二甲双胍联合罗格列酮能使HbA1C和空腹血糖有更显著的降低。
