Profil Institute for Clinical Research, Chula Vista, California, USA.
Diabetes Care. 2011 Mar;34(3):666-8. doi: 10.2337/dc10-1892. Epub 2011 Jan 27.
To compare the pharmacokinetics, pharmacodynamics, and safety of insulin lispro or regular human insulin (RHI) with or without recombinant human hyaluronidase (rHuPH20) administered before a standardized meal.
In this four-way, crossover study, 22 patients with type 1 diabetes received injections of individually optimized doses of lispro or RHI with and without rHuPH20 before a liquid meal.
With rHuPH20 coadministration, early insulin exposure (0-60 min) increased by 54% (P = 0.0011) for lispro and 206% (P < 0.0001) for RHI compared with the respective insulin alone. Peak blood glucose decreased 26 mg/dL for lispro (P = 0.002) and 24 mg/dL for RHI (P = 0.017), reducing hyperglycemic excursions (area under the curve for blood glucose >140 mg/dL) by 79% (P = 0.09) and 85% (P = 0.049), respectively. Rates of hypoglycemia were comparable for lispro with or without rHuPH20, whereas coadministration of RHI and rHuPH20 reduced hypoglycemia.
Lispro or RHI with rHuPH20 produced earlier and greater peak insulin concentrations and improved postprandial glycemic control.
比较经口进食前给予赖脯胰岛素或人胰岛素（RHI）与或不与重组人透明质酸酶（rHuPH20）联用的药代动力学、药效学和安全性。
在这项四交叉研究中，22 例 1 型糖尿病患者接受了个体化优化剂量的赖脯胰岛素或 RHI 与或不与 rHuPH20 的注射，在接受液体餐之前。
与 rHuPH20 联合使用时，赖脯胰岛素（P = 0.0011）和 RHI（P < 0.0001）的早期胰岛素暴露（0-60 分钟）分别增加了 54%和 206%。赖脯胰岛素的血糖峰值降低了 26mg/dL（P = 0.002），RHI 降低了 24mg/dL（P = 0.017），分别减少了 79%（P = 0.09）和 85%（P = 0.049）的高血糖暴露（血糖>140mg/dL 的曲线下面积）。赖脯胰岛素与 rHuPH20 联合使用或不联合使用时，低血糖的发生率相当，而 RHI 与 rHuPH20 联合使用时低血糖发生率降低。
赖脯胰岛素或 RHI 与 rHuPH20 联用可产生更早和更大的胰岛素峰值浓度，并改善餐后血糖控制。
