A 16-week comparison of the novel insulin analog insulin glargine (HOE 901) and NPH human insulin used with insulin lispro in patients with type 1 diabetes
A 16-week comparison of the novel insulin analog insulin glargine (HOE 901) and NPH human insulin used with insulin lispro in patients with type 1 diabetes
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DOI：
10.2337/diacare.23.11.1666
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发表时间：
2000-11-01
期刊：
影响因子：
16.2
通讯作者：
Mecca, T
中科院分区：
文献类型：
--
作者：
Raskin, P;Klaff, L;Mecca, T
研究设计和方法-接受NPH人胰岛素和赖脯胰岛素基础-餐时胰岛素治疗的1型糖尿病患者随机接受甘精胰岛素（HOE 901），一种长效基础胰岛素类似物，一天一次（n = 310）或NPH人胰岛素（n = 309）作为基础治疗，持续餐时赖脯胰岛素16周，在一项开放标签研究中，NPH胰岛素患者维持其先前的每天一次或两次给药的时间表，而甘精胰岛素患者在睡前接受基础胰岛素一天一次。甘精胰岛素治疗患者在家中测量的空腹血糖显著降低（平均值+/-SEM，-42.0 +/-4.7 vs. -12.4 +/-4.7 mg/dl [-2.33 +/-0.26 vs. -0.69 +/-0.26 mmol/l]; P = 0.0001）。这些差异在早期就很明显，并在整个研究过程中持续存在。甘精胰岛素组（29.6%）达到目标空腹血糖119 mg/dl的患者多于NPH组（16.8%）。(
OBJECTIVE - To determine the safety and efficacy of the long-acting insulin analog, insulin glargine, as a component of basal bolus therapy in patients with type I diabetes.RESEARCH DESIGN AND METHODS - Patients with type 1 diabetes receiving basal-bolus insulin treatment with NPH human insulin and insulin lispro mere randomized to receive insulin glargine (HOE 901), a long-acting basal insulin analog, once a day (n = 310) or NPH human insulin (n = 309) as basal treatment with continued bolus insulin lispro for 16 weeks in an open-label study NPH insulin patients maintained their prior schedule of administration once or twice a day, whereas insulin glargine patients received basal insulin once a day at bedtime.RESULTS - Compared with all NPH insulin patients, insulin glargine patients had significant decreases in fasting blood glucose measured at home (means +/- SEM, -42.0 +/- 4.7 vs. - 12.4 +/- 4.7 mg/dl [-2.33 +/- 0.26 vs. -0.69 +/- 0.26 mmol/l]; P = 0.0001). These differences were evident early and persisted throughout the study. More patients in the insulin glargine group (29.6%) than in the NPH group (16.8%) reached a target fasting blood glucose of 119 mg/dl. (