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Insulin degludec's ultra‐long pharmacokinetic properties observed in adults are retained in children and adolescents with type 1 diabetes
Author(s) -
Biester Torben,
Blaesig Sarah,
Remus Kerstin,
Aschemeier Bärbel,
Kordonouri Olga,
Granhall Charlotte,
Søndergaard Flemming,
Kristensen Niels Rode,
Haahr Hanne,
Danne Thomas
Publication year - 2014
Publication title -
pediatric diabetes
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.678
H-Index - 75
eISSN - 1399-5448
pISSN - 1399-543X
DOI - 10.1111/pedi.12116
Subject(s) - medicine , confidence interval , pharmacokinetics , insulin degludec , dosing , crossover study , cmax , type 1 diabetes , diabetes mellitus , insulin , pediatrics , insulin glargine , hypoglycemia , endocrinology , placebo , alternative medicine , pathology
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 IDeg ,0‐∞, SD ) 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 max, IDeg , SD ) was observed. Estimated ratios for C max, IDeg , SD 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.