A randomized pharmacokinetic and pharmacodynamic trial of two regular human insulins demonstrates bioequivalence in type 1 diabetes and availability of biosimilar insulin may improve access to this medication.
A randomized pharmacokinetic and pharmacodynamic trial of two regular human insulins demonstrates bioequivalence in type 1 diabetes and availability of biosimilar insulin may improve access to this medication.
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DOI：
10.1111/dom.14724
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发表时间：
2022-08
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影响因子：
--
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比较Bioton S.A.生产的常规胰岛素（实验药物）治疗剂量的药代动力学（PK）和药效学（PD）效应和安全性。（Warsaw，波兰）与Humulin® R（Eli Lilly（Indianapolis，印第安纳州）生产的常规胰岛素（参比药物））进行比较。在一项单中心、随机、双盲、I期交叉研究中，我们使用手动正常血钳夹技术比较了1型糖尿病（T1 DM）受试者单次皮下注射两种常规胰岛素（0.3单位/kg）的PK和PD特征，两次试验之间的洗脱期为14（± 7）天。我们评估了56名参与者。平均参与者年龄和体重指数分别为32.9岁和22.9 kg/m2。最大血浆胰岛素浓度和血浆胰岛素曲线下面积（AUC）的几何平均值比值（实验/参比）分别为0.909（90%置信区间[CI] 0.822-1.01）和0.993（90% CI 0.944-1.04）。最大葡萄糖输注速率（GIR）和GIR AUC的几何平均值比值分别为0.999（95% CI 0.912-1.09）和1.04（95% CI 0.962-1.12）。试验产品常规人胰岛素和对照药物优泌林® R在T1 DM患者中具有生物等效性。更广泛地进入医药市场的负担得起的，生物类似的常规胰岛素可能会大大改善获得胰岛素的许多社会经济上处于不利地位的糖尿病患者。
To compare the pharmacokinetic (PK) and pharmacodynamic (PD) effects and safety of therapeutic dosages of a regular insulin (experimental drug) produced by Bioton S.A. (Warsaw, Poland) versus Humulin® R, a regular insulin (reference drug) produced by Eli Lilly (Indianapolis, Indiana). In a single-centre, randomized, double-blinded phase 1 crossover study, we used the manual euglycaemic clamp technique to compare PK and PD profiles between single subcutaneous doses (0.3 units/kg) of the two regular insulins in participants with type 1 diabetes (T1DM) with a washout period of 14 (± 7) days between tests. We evaluated 56 participants. The mean participant age and body mass index were 32.9 years and 22.9 kg/m2, respectively. The ratios (experimental/reference) of the geometric means of maximum plasma insulin concentration and for plasma insulin area under the curve (AUC) were 0.909 (90% confidence interval [CI] 0.822-1.01) and 0.993 (90% CI 0.944-1.04), respectively. The ratios of the geometric means of maximum glucose infusion rate (GIR) and for GIR AUC were 0.999 (95% CI 0.912-1.09) and 1.04 (95% CI 0.962-1.12), respectively. The experimental product regular human insulin and comparator Humulin® R are bioequivalent in patients with T1DM. Wider entry to the pharmaceutical market of affordable, biosimilar regular insulins may substantially improve access to insulin for many socioeconomically disadvantaged patients with diabetes.
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影响因子：
16.2
作者：
Davidson MB
通讯作者：
Davidson MB
影响因子：
16.2
作者：
Cefalu, William T.;Dawes, Daniel E.;Yatvin, Alan L.
通讯作者：
Yatvin, Alan L.
影响因子：
5.1
作者：
Gomes, Marilia B.;Coral, Marisa;Negrato, Carlos Antonio
通讯作者：
Negrato, Carlos Antonio
影响因子：
16.2
作者：
Lucidi, Paola;Porcellati, Francesca;Fanelli, Carmine G.
通讯作者：
Fanelli, Carmine G.
影响因子：
5.1
作者：
Gomes, M. B.;Negrato, C. A.
通讯作者：
Negrato, C. A.