Clinical Trial Center, Sahlgrenska University Hospital, Gothenburg, Sweden.
Curr Med Res Opin. 2010 Oct;26(10):2355-63. doi: 10.1185/03007995.2010.511090.
To assess 24-hour glycemic control with saxagliptin compared with placebo as add-on treatment to metformin in patients with type 2 diabetes mellitus (T2DM) and inadequate glycemic control.
This was a 4-week, multicenter, randomized, double-blind, placebo-controlled Phase IIIb trial comparing the antihyperglycemic activity of saxagliptin 5 mg once daily in combination with a stable dose of metformin extended release (XR) vs. placebo in combination with metformin XR in patients with T2DM inadequately controlled (screening glycated hemoglobin [HbA(1c)] 7-10%) with stable doses of metformin immediate release or metformin XR ≥ 1500 mg/day. Ninety-three adult patients were randomized and received treatment. The primary outcome measure was change from baseline to week 4 in 24-hour mean weighted glucose (MWG).
The reduction from baseline in 24-hour MWG was significantly greater for saxagliptin 5 mg + metformin XR (-13.8 mg/dL; -0.77 mmol/L) compared with placebo + metformin XR (3.0 mg/dL; 0.17 mmol/L) (p = 0.0001). At week 4, the mean decrease in plasma glucose was sustained through a 24-hour period in saxagliptin-treated patients. Treatment with saxagliptin 5 mg + metformin XR resulted in significant mean reductions from baseline in 4-hour mean weighted postprandial glucose (PPG), 2-hour PPG, 3-day average mean daily glucose, and fasting plasma glucose levels compared with placebo + metformin XR (p ≤ 0.001). The proportion of adverse events (AEs) was similar in the two treatment groups, with no reported hypoglycemic AEs in saxagliptin-treated patients. The 4-week evaluation period may have been insufficient to evaluate longer term effects on hyperglycemia or to identify additional AEs.
In patients with T2DM treated with metformin XR, saxagliptin 5 mg orally administered once daily in the evening for 4 weeks effectively lowered plasma glucose concentrations through the 24-hour dosing interval and was well tolerated.
评估沙格列汀与安慰剂相比作为二甲双胍添加治疗在血糖控制不佳的 2 型糖尿病（T2DM）患者中的 24 小时血糖控制情况。
这是一项为期 4 周、多中心、随机、双盲、安慰剂对照的 IIIb 期试验，比较了沙格列汀 5mg 每日一次与二甲双胍缓释片（XR）联合治疗与安慰剂与二甲双胍 XR 联合治疗在血糖控制不佳（筛选糖化血红蛋白[HbA1c]7-10%）的 T2DM 患者中的抗高血糖活性，同时使用固定剂量的二甲双胍立即释放或二甲双胍 XR ≥ 1500mg/天。93 名成年患者被随机分组并接受治疗。主要结局指标为从基线到第 4 周的 24 小时平均加权血糖（MWG）变化。
与安慰剂+二甲双胍 XR 组（3.0mg/dL；0.17mmol/L）相比，沙格列汀 5mg+二甲双胍 XR 组的 24 小时 MWG 从基线的降低显著更大（-13.8mg/dL；-0.77mmol/L）（p=0.0001）。在第 4 周，沙格列汀治疗患者的血糖在 24 小时内持续下降。与安慰剂+二甲双胍 XR 组相比，沙格列汀 5mg+二甲双胍 XR 治疗可显著降低 4 小时平均餐后加权血糖（PPG）、2 小时 PPG、3 天平均日血糖和空腹血糖水平的平均值（p≤0.001）。两组的不良事件（AE）比例相似，沙格列汀治疗组未报告低血糖 AE。4 周的评估期可能不足以评估对高血糖的长期影响或识别其他 AE。
在接受二甲双胍 XR 治疗的 T2DM 患者中，沙格列汀 5mg 口服，每晚一次，治疗 4 周，可有效降低 24 小时给药间隔内的血浆葡萄糖浓度，且耐受性良好。
