Insulin degludec's ultra‐long pharmacokinetic properties observed in adults are retained in children and adolescents with type 1 diabetes. Issue 1 (February 2014)

• Record Type: Journal Article
• Authors: Biester, Torben; Blaesig, Sarah; Remus, Kerstin; Aschemeier, Bärbel; Kordonouri, Olga; Granhall, Charlotte; Søndergaard, Flemming; Kristensen, Niels Rode; Haahr, Hanne; Danne, Thomas
• Is Part Of: Pediatric diabetes. Volume 15:Issue 1(2014:Feb.)
• Page Start: 27
• Page End: 33
• Publication Date: 2014-02
• Subjects: Diabetes in children -- Periodicals; 616.462
• DOI: 10.1111/pedi.12116
• Languages: English
• ISSNs: 1399-543X

Abstract

<abstract abstract-type="main" id="pedi12116-abs-0001"> <title> <x xml:space="preserve">Abstract</x> </title> <p id="pedi12116-para-0001">Insulin degludec (IDeg) is a basal insulin with an ultra‐long pharmacokinetic profile in adults that at steady‐state produces remarkably flat and stable insulin levels; however, no studies have yet reported on the pharmacokinetic properties of IDeg in subjects younger than 18 years of age. This was a single‐centre, randomised, single‐dose, double‐blind, two‐period crossover trial conducted in children (6–11 years), adolescents (12–17 years), and adults (18–65 years) with type 1 diabetes. Subjects received a single subcutaneous dose of 0.4 U/kg IDeg or insulin glargine (IGlar), respectively, on two separate dosing visits, with pharmacokinetic blood sampling up to 72‐h postdose. A total of 37 subjects (12 children, 13 adolescents, and 12 adults) completed the trial. Total exposure of IDeg after a single dose (AUC<sub>IDeg</sub><sub>, 0‐∞, </sub><sub>SD</sub>) was higher in children compared to adults [estimated ratio children/adults 1.48 (95% confidence interval, CI: 0.98; 2.24)] and in adolescents compared to adults [estimated ratio adolescents/adults 1.33 (95% CI: 1.08; 1.64)]; however, the difference was only statistically significant for the latter comparison. No statistically significant difference in maximum concentration of IDeg (C<sub>max, </sub><sub>IDeg</sub><sub>, </sub><sub>SD</sub>) was observed. Estimated ratios for C<sub>max, </sub><sub>IDeg</sub><sub>, </sub><sub>SD</sub> were (children/adults) 1.20 (95% CI: 0.90; 1.60) and (adolescents/adults) 1.23 (95% CI: 1.00; 1.51). Simulated mean steady state pharmacokinetic profiles supported a flat and stable IDeg exposure across a 24‐h dosing interval. IDeg was detectable in serum for at least 72 h (end of blood sampling period) in all subjects following single dose. In conclusion, the ultra‐long pharmacokinetic properties of IDeg observed in adults are preserved in children and adolescents with type 1 diabetes.</p> </abstract>