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The DOI matches its Crossref record; 5 of the 5 references it cites were found in a registry or an index.

Insulin degludec's ultra-long pharmacokinetic properties observed in adults are retained in children and adolescents with type 1 diabetes: Insulin degludec in children/adolescents

Biester, Torben, Blaesig, Sarah, Remus, Kerstin, Aschemeier, Bärbel, Kordonouri, Olga, Granhall, Charlotte, Søndergaard, Flemming, Kristensen, Niels Rode, Haahr, Hanne, Danne, Thomas·2014·Pediatric Diabetes
DOI 10.1111/pedi.12116
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Abstract

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.

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Crossref · 10.1111/pedi.12116

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  • Total exposure and maximum concentration of IDeg after a single dose were higher in children and adolescents than in adults, but the difference was only statistically significant for total exposure in adolescents versus adults.

    “the total exposure (AUCIDeg,0–∞,SD) and maximum concentration (C max) of IDeg after a SD (C max,IDeg,SD) were higher in children and adolescents than in adults [estimated ratio for AUCIDeg,0–∞,SD children/adults 1.48 (95 % CI 0.98–2.24) and adolescents/adults 1.33 (95 % CI 1.08–1.64); estimated ratio for C max,IDeg,SD children/adults 1.20 (95 % CI 0.90–1.60) and adolescents/adults 1.23 (95 % CI 1.”

    From A Review of the Pharmacological Properties of Insulin Degludec and Their Clinical Relevance (2014) · cites this paper as [29]

  • A single-centre, randomised, single-dose, double-blind, two-period crossover trial with IDeg was conducted in children (6-11 years), adolescents (12-17 years) and adults (18-65 years) with T1DM.

    “a single-centre, randomised, SD, double-blind, two-period crossover trial with IDeg was conducted in children (6–11 years), adolescents (12–17 years) and adults (18–65 years) with T1DM [29].”

    From A Review of the Pharmacological Properties of Insulin Degludec and Their Clinical Relevance (2014) · cites this paper as [29]

  • Simulated mean steady-state pharmacokinetic profiles supported a flat and stable IDeg exposure across a 24-h dosing interval in all sub-populations.

    “The simulated mean SS pharmacokinetic profiles supported a flat and stable IDeg exposure across a 24-h dosing interval in all of the sub-populations [29].”

    From A Review of the Pharmacological Properties of Insulin Degludec and Their Clinical Relevance (2014) · cites this paper as [29]

  • The pharmacokinetic properties of IDeg observed in adults are preserved in children and adolescents with T1DM.

    “In general, the study found that the pharmacokinetic properties of IDeg observed in adults are preserved in children and adolescents with T1DM.”

    From A Review of the Pharmacological Properties of Insulin Degludec and Their Clinical Relevance (2014) · cites this paper as [29]

Citations

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Research works printed but not linked: 21

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  11. Heise, 2012, Insulin degludec: four times lower pharmacodynamic variability than insulin glargine under steady-state conditions in type 1 diabetes, Diabetes Obes Metab, 14, 859, 10.1111/j.1463-1326.2012.01627.x · DOI · Paper page
  12. Heise, 2012, Insulin degludec: two-fold longer half-life and a more consistent pharmacokinetic profile than insulin glargine, Endocr Abstr, 28, 188
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Metadata

Authors
Biester, T., Blaesig, S., Remus, K., Aschemeier, B., Kordonouri, O., Granhall, C., Søndergaard, F., Kristensen, N. R., Haahr, H., & Danne, T.
Affiliations
  • Kinderkrankenhaus auf der Bult (DE)
  • Diabetes Centre for Children and Adolescents; Kinder- und Jugendkrankenhaus auf der Bult; Hannover Germany
  • Novo Nordisk (Denmark) (DK)
Corresponding author
Danne, Thomas
ORCID
Venue
Pediatric Diabetes
Publisher
Hindawi Limited
Published
2014-01-28
Volume
15
Issue
1
Pages
27-33
ISSN
1399-543X (ISSN-L)
DOI
10.1111/pedi.12116
OpenAlex
W1709260067
Cited by
53
References
5
Citations by year
2025: 3 · 2024: 2 · 2023: 2 · 2022: 4 · 2021: 4 · 2020: 3 · 2019: 7 · 2018: 4 · 2016: 7 · 2015: 10 · 2014: 7
FWCI
6.44
Type
journal article
Language
en
Open access
closed
Licence
doi.wiley.com/10.1002/tdm_license_1.1 (tdm, 581 d)
Locations
  • Pediatric Diabetes (publishedVersion)
  • PubMed (publishedVersion)
Funders
Sanofi
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Diabetes and associated disorders
Keywords
insulin degludec, type 1 diabetes, pediatric patients, adolescents, pharmacokinetics, ultra-long-acting insulin, insulin glargine
MeSH terms
Insulin Glargine, Adolescent, Adult, Child, Diabetes Mellitus, Type 1, Double-Blind Method, Female, Humans, Hypoglycemic Agents, Insulin, Male, Insulin, Long-Acting

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