Pharmacokinetics of diluted (U20) insulin aspart compared with standard (U100) in children aged 3–6 years with type 1 diabetes during closed-loop insulin delivery: a randomised clinical trial
| العنوان: | Pharmacokinetics of diluted (U20) insulin aspart compared with standard (U100) in children aged 3–6 years with type 1 diabetes during closed-loop insulin delivery: a randomised clinical trial |
|---|---|
| المؤلفون: | Ruan, Yue, Elleri, Daniela, Allen, Janet M, Tauschmann, Martin, Wilinska, Malgorzata E, Dunger, David B, Hovorka, Roman |
| المساهمون: | Tauschmann, Martin [0000-0002-2305-2490], Wilinska, Gosia [0000-0003-2739-1753], Dunger, David [0000-0002-2566-9304], Hovorka, Roman [0000-0003-2901-461X], Apollo - University of Cambridge Repository |
| المصدر: | Diabetologia |
| بيانات النشر: | Springer Berlin Heidelberg, 2014. |
| سنة النشر: | 2014 |
| مصطلحات موضوعية: | Blood Glucose, Male, Cross-Over Studies, Insulin concentration, Endocrinology, Diabetes and Metabolism, Short Communication, Aspart, Young children, Insulin absorption, Rapid-acting insulin, Models, Biological, Drug Administration Schedule, Type 1 diabetes, Diabetes Mellitus, Type 1, Insulin Infusion Systems, Treatment Outcome, Child, Preschool, Internal Medicine, Humans, Hypoglycemic Agents, Pharmacokinetics, Female, Drug Monitoring, Child, Insulin Aspart |
| الوصف: | Aims/hypothesis The aim of this study was to compare the pharmacokinetics of two different concentrations of insulin aspart (B28Asp human insulin) in children aged 3–6 years with type 1 diabetes. Methods Young children with type 1 diabetes underwent an open-label, randomised, two-period crossover study in a clinical research facility, 2–6 weeks apart. In random order, diluted (1:5 dilution with saline [154 mmol/l NaCl]; 20 U/ml) or standard strength (100 U/ml) insulin aspart was administered via an insulin pump as a meal bolus and then overnight by closed-loop insulin delivery as determined by a model predictive algorithm. Plasma insulin was measured every 30–60 min from 17:00 hours on day 1 to 8:00 hours on day 2. We measured the time-to-peak insulin concentration (tmax), insulin metabolic clearance rate (MCRI) and background insulin concentration (insc) using compartmental modelling. Results Eleven children (six male; age range 3.75–6.96 years, HbA1c 7.6% ± 1.3% [60 ± 14 mmol/mol], BMI standard deviation score 1.0 ± 0.8, duration of diabetes 2.2 ± 1.0 years, total daily dose 12.9 [10.6–16.5] U, fasting C-peptide concentration 5 [5–17.1] pmol/l; mean ± SD or median [interquartile range]) participated in the study. No differences between standard and diluted insulin were observed in terms of tmax (59.2 ± 14.4 vs 61.6 ± 8.7) min for standard vs diluted, p = 0.59; MCRI (1.98 × 10−2 ± 0.99 × 10−2 vs 1.89 × 10−2 ± 0.82 × 10−2 1/kg/min, p = 0.47), and insc (34 [1–72] vs 23 [3–65] pmol/l, p = 0.66). However, tmax showed less intersubject variability following administration of diluted aspart (SD 14.4 vs 8.7 min, p = 0.047). Conclusions/interpretation Diluting insulin aspart does not change its pharmacokinetics. However, it may result in less variable absorption and could be used in young children with type 1 diabetes undergoing closed-loop insulin delivery. Trial registration: Clinicaltrials.gov NCT01557634 Funding: Funding was provided by the JDRF, 7th Framework Programme of the European Union, Wellcome Trust Strategic Award and the National Institute for Health Research Cambridge Biomedical Research Centre. Electronic supplementary material The online version of this article (doi:10.1007/s00125-014-3483-6) contains peer-reviewed but unedited supplementary material, which is available to authorised users. |
| وصف الملف: | application/pdf |
| اللغة: | English |
| تدمد: | 1432-0428 0012-186X |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=pmid_dedup__::42d09f25f99d22ab31b720b34c3b42a2Test http://europepmc.org/articles/PMC4351431Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.pmid.dedup....42d09f25f99d22ab31b720b34c3b42a2 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 14320428 0012186X |
|---|