Addition of biphasic, prandial, or basal insulin to oral therapy in type 2 diabetes
Addition of biphasic, prandial, or basal insulin to oral therapy in type 2 diabetes
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DOI：
10.1056/nejmoa075392
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发表时间：
2007-10-25
影响因子：
158.5
通讯作者：
Levy, Jonathan C.
中科院分区：
文献类型：
--
作者：
Holman, Rury R.;Thorne, Kerensa I.;Levy, Jonathan C.
背景：当2型糖尿病患者血糖控制不佳时，通常在口服治疗中加入胰岛素，尽管支持特定胰岛素治疗方案的证据有限。方法在一项开放标签、对照、多中心试验中，我们随机分配708例糖化血红蛋白水平不理想（7.0 - 10.0%）的患者，这些患者正在接受最大耐受剂量的二甲双胍和磺脲治疗，分别接受每日2次双相天冬氨酸胰岛素治疗、每日3次膳食天冬氨酸胰岛素治疗或每日1次基础地冬氨酸胰岛素治疗（必要时2次）。1年的结局指标是平均糖化血红蛋白水平、糖化血红蛋白水平为6.5%或更低的患者比例、低血糖率和体重增加。结果1年平均糖化血红蛋白水平在双相组（7.3%）和正餐组（7.2%）相似（P=0.08），但在基础组（7.6%，P=0.08）较高
BackgroundAdding insulin to oral therapy in type 2 diabetes mellitus is customary when glycemic control is suboptimal, though evidence supporting specific insulin regimens is limited.MethodsIn an open-label, controlled, multicenter trial, we randomly assigned 708 patients with a suboptimal glycated hemoglobin level (7.0 to 10.0%) who were receiving maximally tolerated doses of metformin and sulfonylurea to receive biphasic insulin aspart twice daily, prandial insulin aspart three times daily, or basal insulin detemir once daily (twice if required). Outcome measures at 1 year were the mean glycated hemoglobin level, the proportion of patients with a glycated hemoglobin level of 6.5% or less, the rate of hypoglycemia, and weight gain.ResultsAt 1 year, mean glycated hemoglobin levels were similar in the biphasic group (7.3%) and the prandial group (7.2%) (P=0.08) but higher in the basal group (7.6%, P