Plank Johannes, Wutte Andrea, Brunner Gernot, Siebenhofer Andrea, Semlitsch Barbara, Sommer Romana, Hirschberger Sabine, Pieber Thomas R
Diabetes und Metabolism, Department of Internal Medicine, Karl-Franzens University of Graz, Graz, Austria.
Diabetes Care. 2002 Nov;25(11):2053-7. doi: 10.2337/diacare.25.11.2053.
Both rapid-acting insulin analogs, insulin aspart and lispro, attenuate prandial glucose excursion compared with human soluble insulin. This trial was performed to study the pharmacokinetic and pharmacodynamic profiles of insulin aspart and insulin lispro in type 1 diabetic patients in a direct comparison and to investigate whether the administration of one analog results in favorable effects on prandial blood glucose control.
A total of 24 type 1 diabetic patients (age 36 +/- 8 years, 16 men and 8 women, BMI 24.3 +/- 2.6 kg/m(2), diabetes duration 17 +/- 11 years, HbA(1c) 7.9 +/- 0.8%) on intensified insulin therapy were recruited into a single-center, randomized, double-blind, two-period, cross-over, glucose clamp trial. The subjects were given an individual need-derived dose of prandial insulin lispro or aspart immediately before a standard mixed meal.
With respect to blood glucose excursions from time 0 to 6 h (Exc(glu(0-6 h))) and from time 0 to 4 h (Exc(glu(0-4 h))), the pharmacodynamic effect of insulin aspart and insulin lispro can be declared equivalent. This was supported by comparison with maximum postprandial blood glucose excursions (C(max(glu))) (estimated ratio aspart/lispro ANOVA [90% CI]: 0.95 [0.80-1.13], 0.97 [0.82-1.17], and 1.01 [0.95-1.07] for Exc(glu(0-6 h)), Exc(glu(0-4 h)), and C(max(glu)), respectively). For pharmacokinetic end points (maximum postprandial insulin excursions and area under the curve for insulin from time 0 to 6 h and from time 0 to 4 h), equivalence was indicated. No difference concerning absorption or elimination for time to maximal insulin concentration, time to half-maximum insulin concentration, and time to decrease to 50% of maximum insulin concentration was observed.
These data suggest that in type 1 diabetic patients, both insulin analogs are equally effective for control of postprandial blood glucose excursions.
与可溶性人胰岛素相比，速效胰岛素类似物门冬胰岛素和赖脯胰岛素均可减弱餐后血糖波动。开展此项试验以直接比较门冬胰岛素和赖脯胰岛素在1型糖尿病患者中的药代动力学和药效学特征，并研究给予其中一种类似物是否会对餐后血糖控制产生有利影响。
强化胰岛素治疗的24例1型糖尿病患者（年龄36±8岁，男性16例，女性8例，体重指数24.3±2.6kg/m²，糖尿病病程17±11年，糖化血红蛋白7.9±0.8%）被纳入一项单中心、随机、双盲、两阶段、交叉、葡萄糖钳夹试验。在标准混合餐之前，给受试者按个体需求给予一剂餐时赖脯胰岛素或门冬胰岛素。
就0至6小时（Exc(glu(0 - 6 h))）和0至4小时（Exc(glu(0 - 4 h))）的血糖波动而言，门冬胰岛素和赖脯胰岛素的药效学效应可认为是等效的。这一点通过与餐后最大血糖波动（C(max(glu))）比较得到支持（门冬胰岛素/赖脯胰岛素方差分析估计比值[90%置信区间]：Exc(glu(0 - 6 h))为0.95[0.80 - 1.13]，Exc(glu(0 - 4 h))为0.97[0.82 - 1.17]，C(max(glu))为1.01[0.95 - 1.07]）。对于药代动力学终点（餐后最大胰岛素波动以及0至6小时和0至4小时胰岛素曲线下面积），显示出等效性。在达到最大胰岛素浓度的时间、达到最大胰岛素浓度一半的时间以及降至最大胰岛素浓度50%的时间方面，未观察到吸收或消除的差异。
这些数据表明，在1型糖尿病患者中，两种胰岛素类似物在控制餐后血糖波动方面同样有效。
