التفاصيل البيبلوغرافية
| العنوان: |
The association between anti‐insulin aspart antibodies and the pharmacokinetic and pharmacodynamic characteristics of fast‐acting insulin aspart in children and adolescents with type 1 diabetes. |
| المؤلفون: |
Biester, Torben, von dem Berge, Thekla, Bendtsen, Line Quist, Bendtsen, Mette Dahl, Rathor, Naveen, Danne, Thomas, Haahr, Hanne |
| المصدر: |
Pediatric Diabetes; Aug2020, Vol. 21 Issue 5, p781-790, 10p, 4 Charts, 3 Graphs |
| مصطلحات موضوعية: |
SUBCUTANEOUS injections, BLOOD sugar, CROSSOVER trials, IMMUNOGLOBULINS, INGESTION, TYPE 1 diabetes, RANDOMIZED controlled trials, BLIND experiment, INSULIN aspart, PHARMACODYNAMICS |
| مستخلص: |
Background: Fast‐acting insulin aspart (faster aspart) is a novel formulation of insulin aspart (IAsp) ensuring ultrafast absorption and effect. Aim: To compare the pharmacokinetics between faster aspart and IAsp, based on free or total IAsp measurement, and investigate the association between anti‐IAsp antibodies and faster aspart and IAsp pharmacological properties in children and adolescents with type 1 diabetes (T1D). Methods: In a randomized, two‐period crossover trial, 12 children, 16 adolescents, and 15 adults (6‐11, 12‐17, and 18‐64 years) received 0.2 U/kg double‐blindsingle‐dose subcutaneous faster aspart or IAsp followed by a standardized liquid meal test. Results: Across age groups, the pharmacokinetic profile was left‐shifted including greater early exposure for faster aspart vs IAsp irrespective of free or total IAsp assay. Onset of appearance occurred 2.4 to 5.0 minutes (free) or 1.8 to 3.0 minutes (total) earlier for faster aspart vs IAsp (P <.05). Treatment ratios (faster aspart/IAsp) for 0 to 30 minutes IAsp exposure were 1.60 to 2.11 and 1.62 to 1.96, respectively (children, free: P =.062; otherwise P <.05). The ratio of free/total IAsp for overall exposure (AUCIAsp,0‐t) was negatively associated with anti‐IAsp antibody level across age. Pooling with a previous similar trial showed no clear association between anti‐IAsp antibodies and meal test 1‐ or 2‐hour postprandial glucose increment independent of age and insulin treatment (R2 ≤.070; P ≥.17). Conclusions: In children and adolescents with T1D, faster aspart provides ultrafast pharmacokinetics irrespective of free or total IAsp assay. Elevated anti‐IAsp antibodies are associated with higher total IAsp concentration, but do not impact faster aspart and IAsp glucose‐lowering effect. [ABSTRACT FROM AUTHOR] |
|
Copyright of Pediatric Diabetes is the property of Hindawi Limited and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.) |
| قاعدة البيانات: |
Complementary Index |
Full Text Finder