caa a22 4500 47578474X CHVBK 20180406123654.0 cr unu---uuuuu 170329e20000601xx s 000 0 eng 10.1007/s004310051315 doi (NATIONALLICENCE)springer-10.1007/s004310051315 Rapid appearance and onset of action of insulin aspart in paediatric subjects with type 1 diabetes [Elektronische Daten] [Henrik B. Mortensen, Anders Lindholm, Birthe S. Olsen, Birgitte Hylleberg] The pharmacokinetics of the novel, rapid-acting insulin aspart were compared with those of soluble human insulin following subcutaneous administration in nine children (aged 6-12 years) and nine adolescents (aged 13-17 years) with stable type 1 diabetes. The study had a randomised, double-blind, two-period crossover design. Each patient received a single subcutaneous dose of insulin aspart or human insulin (0.15 IU/kg body weight) 5 min before breakfast and the plasma insulin and glucose concentrations were measured at intervals during the following 5 h. The pharmacokinetic profile of insulin aspart differed significantly from that of human insulin with a higher mean maximum serum insulin (Cmax ins), 881 ± 321 (SD) pmol/l versus 422 ± 193 pmol/l for human insulin (P < 0.001); and with a shorter median serum insulin t max ins, 40.0 min (interquartile range: 40-50 min) versus 75.0 min (interquartile range: 60-120 min) for human insulin, (P < 0.001). An age-related effect on Cmax ins and area under the curve (AUC0-5h ins) was observed with higher values in adolescents than in children for both insulin aspart and human insulin. Postprandial glycaemic control was improved with insulin aspart; the baseline-adjusted ΔCmax glu being lower for insulin aspart compared with human insulin (increase of 7.6 ± 5.1 versus 9.4 ± 4.4 mmol/l respectively, P < 0.05). The incidence of adverse events was similar for the two insulin types. Conclusion The more rapid onset of action of insulin aspart versus human insulin, previously observed in adults, is confirmed in a paediatric population with type 1 diabetes. Springer-Verlag Berlin Heidelberg, 2000 Key words Insulin aspart nationallicence Insulin analogue nationallicence Type 1 diabetes nationallicence Pharmacokinetics nationallicence Children nationallicence Mortensen Henrik B. Paediatric Department, University Hospital 2600 Glostrup, Denmark e-mail: hbm@dad1net.dk Tel.: +45-43-232967; Fax: +45-43-233964, DK aut Lindholm Anders Novo Nordisk A/S, Novo Allé, 2880 Bagsvaerd, Denmark, DK aut Olsen Birthe S. Paediatric Department, University Hospital 2600 Glostrup, Denmark e-mail: hbm@dad1net.dk Tel.: +45-43-232967; Fax: +45-43-233964, DK aut Hylleberg Birgitte Novo Nordisk A/S, Novo Allé, 2880 Bagsvaerd, Denmark, DK aut https://doi.org/10.1007/s004310051315 text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/s004310051315 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Mortensen Henrik B. Paediatric Department, University Hospital 2600 Glostrup, Denmark e-mail: hbm@dad1net.dk Tel.: +45-43-232967; Fax: +45-43-233964, DK aut NATIONALLICENCE 700 1- Lindholm Anders Novo Nordisk A/S, Novo Allé, 2880 Bagsvaerd, Denmark, DK aut NATIONALLICENCE 700 1- Olsen Birthe S. Paediatric Department, University Hospital 2600 Glostrup, Denmark e-mail: hbm@dad1net.dk Tel.: +45-43-232967; Fax: +45-43-233964, DK aut NATIONALLICENCE 700 1- Hylleberg Birgitte Novo Nordisk A/S, Novo Allé, 2880 Bagsvaerd, Denmark, DK aut Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer