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首页> 外文期刊>Journal of diabetes investigation. >Insulin degludec/insulin aspart in Japanese patients with type 1 diabetes mellitus: Distinct prandial and basal glucose‐lowering effects
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Insulin degludec/insulin aspart in Japanese patients with type 1 diabetes mellitus: Distinct prandial and basal glucose‐lowering effects

机译：日本1型糖尿病患者的地高卢德胰岛素/门冬胰岛素：明显的餐后和基础降糖作用

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Aims/Introduction Insulin degludec/insulin aspart (IDegAsp) is a soluble co-formulation of long-acting insulin degludec (IDeg) and rapid-acting insulin aspart (IAsp). The present study investigated the pharmacodynamic properties of IDegAsp in Japanese patients with type 1 diabetes mellitus. Materials and Methods In this randomized, double-blind, two-period, cross-over trial, 21 Japanese patients with type 1 diabetes mellitus received single doses of 0.5 U/kg IDegAsp and biphasic insulin aspart 30 in a randomized sequence (13–21 days washout between treatments). The pharmacodynamic response was evaluated in a 26-h euglycemic glucose clamp (target 5.5 mmol/L). Single-dose IDegAsp glucose infusion rate (GIR) profiles were extrapolated to steady state using modeling. Results The IDegAsp single-dose GIR profile showed a clear distinction between the effects of the bolus (IAsp) and basal (IDeg) components in IDegAsp. When simulated to steady state, the GIR profile of IDegAsp was shifted upwards compared with the single-dose profile, and showed a rapid onset of action and a distinct peak from the IAsp component followed by a separate and sustained basal action from the long-acting IDeg component. For biphasic insulin aspart 30, the initial shape of the GIR profile was similar to IDegAsp, but GIR continuously decreased from maximum and reached zero 18–20 h post-dosing. The characteristics of the GIR profile for IDegAsp were retained when simulated to steady state in a twice-daily dosing regimen. Discussion In Japanese patients with type 1 diabetes mellitus, the pharmacodynamic profile of IDegAsp is characterized by distinct prandial and basal effects from the IAsp and IDeg components, consistent with what has been reported previously in Caucasian patients with type 1 diabetes mellitus.
机译：目标/简介地格胰岛素/门冬胰岛素（IDegAsp）是长效胰岛素地格胰岛素（IDeg）和速效门冬胰岛素（IAsp）的可溶性共制剂。本研究调查了IDegAsp在日本1型糖尿病患者中的药效学特性。资料和方法在这项随机，双盲，两期，交叉试验中，21名日本1型糖尿病患者接受了随机分配的单剂量0.5 U / kg IDegAsp和双相门冬胰岛素30（13–21）。两次治疗之间的冲洗天数）。在26小时的正常血糖钳夹（目标5.5 mmol / L）中评估药效学反应。使用建模将单剂量IDegAsp葡萄糖输注速率（GIR）曲线外推至稳态。结果IDegAsp单剂量GIR谱显示在IDegAsp中推注（IAsp）和基础（IDeg）成分的作用之间有明显区别。当模拟为稳态时，IDegAsp的GIR图谱与单剂量图谱相比向上移动，并且显示出快速起效和IAsp组分的明显峰，随后是与长效分离且持续的基础作用IDeg组件。对于双相胰岛素门冬氨酸30，GIR曲线的初始形状与IDegAsp相似，但是GIR从最大值连续降低，并在给药后18-20 h达到零。在每天两次的给药方案中模拟达到稳态时，IDegAsp的GIR谱特征得以保留。讨论在日本的1型糖尿病患者中，IDegAsp的药效学特征是IAsp和IDeg成分具有明显的餐后和基础作用，这与以前在白种人的1型糖尿病患者中所报道的一致。

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