التفاصيل البيبلوغرافية
| العنوان: |
Insulin degludec's ultra-long pharmacokinetic properties observed in adults are retained in children and adolescents with type 1 diabetes. |
| المؤلفون: |
Biester, Torben, Blaesig, Sarah, Remus, Kerstin, Aschemeier, Bärbel, Kordonouri, Olga, Granhall, Charlotte, Søndergaard, Flemming, Kristensen, Niels Rode, Haahr, Hanne, Danne, Thomas |
| المصدر: |
Pediatric Diabetes; Feb2014, Vol. 15 Issue 1, p27-33, 7p |
| مصطلحات موضوعية: |
INSULIN pharmacokinetics, TREATMENT of diabetes, TYPE 1 diabetes, CLINICAL trials, CONFIDENCE intervals, ENZYME-linked immunosorbent assay, INSULIN, PEDIATRICS, SAFETY, DATA analysis |
| مستخلص: |
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 ( AUCIDeg,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 (Cmax, IDeg, SD) was observed. Estimated ratios for Cmax, 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. [ABSTRACT FROM AUTHOR] |
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| قاعدة البيانات: |
Complementary Index |
