Ultra rapid lispro showed greater reduction in postprandial glucose versus Humalog in children, adolescents and adults with type 1 diabetes mellitus.
insulin therapy
pharmacodynamics
pharmacokinetics
type 1 diabetes mellitus
ultra rapid insulin
Journal
Diabetes, obesity & metabolism
ISSN: 1463-1326
Titre abrégé: Diabetes Obes Metab
Pays: England
ID NLM: 100883645
Informations de publication
Date de publication:
07 2023
07 2023
Historique:
revised:
15
03
2023
received:
06
01
2023
accepted:
20
03
2023
medline:
5
6
2023
pubmed:
29
3
2023
entrez:
28
3
2023
Statut:
ppublish
Résumé
This study compared the pharmacokinetics, glucodynamics and tolerability following single subcutaneous doses of ultra rapid lispro (URLi) versus Humalog in children (6-11 years), adolescents (12-17 years) and adults (18-64 years) with type 1 diabetes mellitus (T1D). The study was a randomized, two-period, subject- and investigator-blind, crossover design in participants with T1D. Participants received a 0.2 U/kg bolus dose immediately before a liquid mixed meal tolerance test. Insulin lispro and glucose concentrations were measured. The study included 13 children, 14 adolescents and 15 adults. Consistently across the age groups, onset of appearance was 4-5 min faster, the early 50% t URLi showed an accelerated insulin lispro absorption and greater postprandial glucose reduction compared with Humalog in children, adolescents and adults with T1D.
Substances chimiques
Insulin Lispro
0
Hypoglycemic Agents
0
Glucose
IY9XDZ35W2
Blood Glucose
0
Insulin
0
Types de publication
Randomized Controlled Trial
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1964-1972Informations de copyright
© 2023 Eli Lilly and Company and The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.
Références
Ward ZJ, Yeh JM, Reddy CL, et al. Estimating the total incidence of type 1 diabetes in children and adolescents aged 0-19 years from 1990 to 2050: a global simulation-based analysis. Lancet Diabetes Endocrinol. 2022;10(12):848-858. doi:10.1016/S2213-8587(22)00276-5
White NH, Sun W, Cleary PA, et al. Effect of prior intensive therapy in type 1 diabetes on 10-year progression of retinopathy in the DCCT/EDIC: comparison of adults and adolescents. Diabetes. 2010;59(5):1244-1253. doi:10.2337/db09-1216
Grunberger G. Insulin analogs-are they worth it? Yes! Diabetes Care. 2014;37(6):1767-1770. doi:10.2337/dc14-0031
Kalra S, Gupta Y. Ultra-fast acting insulin analogues. Recent Pat Endocr Metab Immune Drug Discov. 2014;8(2):117-123. doi:10.2174/1872214808666140714112644
Heinemann L, Muchmore DB. Ultrafast-acting insulins: state of the art. J Diabetes Sci Technol. 2012;6(4):728-742. doi:10.1177/193229681200600402
Cengiz C, Danne T, Ahmad T, et al. ISPAD Clinical Practice Consensus Guidelines 2022: insulin treatment in children and adolescents with diabetes. Pediatr Diabetes. 2022;23:1277-1296.
Heise T, Piras de Oliveira C, Juneja R, Ribeiro A, Chigutsa F, Blevins T. What is the value of faster acting prandial insulin? Focus on ultra rapid lispro. Diabetes Obes Metab. 2022;24(9):1689-1701. doi:10.1111/dom.14773
Kazda C, Leohr J, Liu R, et al. Ultra rapid lispro (URLi) shows accelerated pharmacokinetics and greater reduction in postprandial glucose versus Humalog(R) in patients with type 1 diabetes mellitus in a randomized, double-blind meal test early-phase study. Diabetes Obes Metab. 2022;24(2):196-203. doi:10.1111/dom.14563
Linnebjerg H, Zhang Q, LaBell E, et al. Pharmacokinetics and Glucodynamics of ultra rapid Lispro (URLi) versus Humalog((R)) (Lispro) in younger adults and elderly patients with type 1 diabetes mellitus: a randomised controlled trial. Clin Pharmacokinet. 2020;59(12):1589-1599. doi:10.1007/s40262-020-00903-0
Klaff L, Cao D, Dellva MA, et al. Ultra rapid lispro improves postprandial glucose control compared with lispro in patients with type 1 diabetes: results from the 26-week PRONTO-T1D study. Diabetes Obes Metab. 2020;22(10):1799-1807. doi:10.1111/dom.14100
Wadwa RP, Laffel LM, Franco DR, Dellva MA, Knights AW, Pollom RK. Efficacy and safety of ultra-rapid lispro versus lispro in children and adolescents with type 1 diabetes: the PRONTO-Peds trial. Diabetes Obes Metab. 2022;25:89-97. doi:10.1111/dom.14849
WHO. WHO. BMI-for-Age (5-19 years). https://www.who.int/tools/growth-reference-data-for-5to19-years/indicators/bmi-for-age. Accessed December 8, 2022.
Chow S-C, Liu J-P. Design and Analysis of Bioavailability and Bioequivalence Studies. Boca Raton, FL: CRC Press; 1999.
Fath M, Danne T, Biester T, Erichsen L, Kordonouri O, Haahr H. Faster-acting insulin aspart provides faster onset and greater early exposure vs insulin aspart in children and adolescents with type 1 diabetes mellitus. Pediatr Diabetes. 2017;18(8):903-910. doi:10.1111/pedi.12506
Biester T, von dem Berge T, Bendtsen LQ, et al. 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. Pediatr Diabetes. 2020;21(5):781-790. doi:10.1111/pedi.13026
Bruttomesso D, Pianta A, Mari A, et al. Restoration of early rise in plasma insulin levels improves the glucose tolerance of type 2 diabetic patients. Diabetes. 1999;48(1):99-105. doi:10.2337/diabetes.48.1.99