A Comparison of Pharmacokinetic and Pharmacodynami

Authors: Tim Heise Ulrike Hövelmann Eric Zijlstra Kirstine StenderPetersen Jacob Bonde Jacobsen Hanne Haahr

Publish Date: 2016/11/21

Volume: 34, Issue: 1, Pages: 29-38

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Abstract

Due to population aging an increasing number of elderly patients with diabetes use insulin It is therefore important to investigate the characteristics of new insulins in this population Fasteracting insulin aspart faster aspart is insulin aspart IAsp in a new formulation with faster absorption This study investigated the pharmacological properties of faster aspart in elderly subjects with type 1 diabetes mellitus T1DMIn a randomised doubleblind twoperiod crossover trial 30 elderly ≥65 years and 37 younger adults 18–35 years with T1DM received single subcutaneous faster aspart or IAsp dosing 02 U/kg and underwent an euglycaemic clamp target 55 mmol/L for up to 12 hThe pharmacokinetic and pharmacodynamic time profiles were leftshifted for faster aspart versus IAsp In each age group onset of appearance occurred approximately twice as fast ~3 min earlier and early exposure area under the concentration–time curve AUC for serum IAsp from time zero to 30 min AUCIAsp030 min was greater by 86 in elderly and 67 in younger adults for faster aspart than for IAsp Likewise onset of action occurred 10 min faster in the elderly and 9 min faster in younger adults and early glucoselowering effect AUC for the glucose infusion rate GIR from time zero to 30 min AUCGIR030 min was greater by 109 for faster aspart than for IAsp in both age groups Total exposure AUCIAsp0t and the maximum concentration C max for faster aspart were greater by 30 and 28 respectively in elderly than in younger adults No age group differences were seen for the total AUCGIR0t or maximum GIRmax glucoselowering effect

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