دورية أكاديمية
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. |
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| المؤلفون: | Ruan, Yue, Elleri, Daniela, Allen, Janet M, Tauschmann, Martin, Wilinska, Malgorzata E, Dunger, David B, Hovorka, Roman |
| بيانات النشر: | Springer Verlag //dx.doi.org/10.1007/s00125-014-3483-6 Diabetologia |
| سنة النشر: | 2015 |
| المجموعة: | Apollo - University of Cambridge Repository |
| مصطلحات موضوعية: | Blood Glucose, Child, Preschool, Cross-Over Studies, Diabetes Mellitus, Type 1, Drug Administration Schedule, Drug Monitoring, Female, Humans, Hypoglycemic Agents, Insulin Aspart, Insulin Infusion Systems, Male, Models, Biological, Treatment Outcome |
| 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 (MCR(I)) and background insulin concentration (ins(c)) 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 t max (59.2 ± 14.4 vs 61.6 ± 8.7) min for standard vs diluted, p = 0.59; MCR I (1.98 × 10(-2) ± 0.99 × 10(-2) vs 1.89 × 10(-2) ± 0.82 × 10(-2) 1/kg/min, p = 0.47), and ins c (34 [1-72] vs 23 [3-65] pmol/l, p = 0.66). However, t max 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, ... |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | application/pdf |
| اللغة: | English |
| العلاقة: | https://www.repository.cam.ac.uk/handle/1810/246832Test |
| الإتاحة: | https://www.repository.cam.ac.uk/handle/1810/246832Test |
| حقوق: | Attribution 2.0 UK: England & Wales ; http://creativecommons.org/licenses/by/2.0/ukTest/ |
| رقم الانضمام: | edsbas.BBEF087 |
| قاعدة البيانات: | BASE |
| الوصف غير متاح. |