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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):903-910PD

Abstract

BACKGROUND

Faster-acting insulin aspart (faster aspart) is insulin aspart (IAsp) in a new formulation with additional excipients (L-arginine and niacinamide). In adults, faster aspart provides faster onset and greater early exposure and action vs IAsp.

AIM

This randomized, double-blind, 2-period crossover trial investigated the pharmacological properties of faster aspart vs IAsp in 12 children (6-11 years), 13 adolescents (12-17 years), and 15 adults (18-64 years) with type 1 diabetes mellitus.

METHODS

Subjects received 0.2 U/kg subcutaneous dosing (mean of 8.3, 12.8, and 15.6 U, respectively) immediately prior to a standardized meal (17.3 g carbohydrate/100 mL; amount adjusted by body weight).

RESULTS

Consistently across age groups, onset of appearance occurred approximately twice-as-fast (5-7 minutes earlier) and early exposure (AUCIAsp,0-30min ; area under the IAsp curve from 0 to 30 minutes) was greater (by 78%-147%) for faster aspart vs IAsp, with no treatment differences in total exposure (AUCIAsp,0-t) or maximum concentration (C max). Two-hour postmeal plasma glucose excursion was reduced for faster aspart vs IAsp (although only reaching statistical significance in children). In accordance with the absolute dose administered for each age group, AUCIAsp,0-t for faster aspart was lower in children (estimated ratio children/adults [95% confidence interval]: 0.59 [0.50;0.69], P < .001) and adolescents (0.78 [0.67;0.90], P = .002) vs adults. No age group differences were seen in C max (0.91 [0.70;1.17], P = .445, and 0.99 [0.77;1.26], P = .903). The age effect on AUCIAsp,0-t and C max did not differ statistically significantly between treatments. Faster aspart and IAsp were well-tolerated.

CONCLUSION

The current findings in children and adolescents suggest a potential for faster aspart to improve postprandial glycemia over current rapid-acting insulins also in younger age groups. http://ClinicalTrials.gov identifier: NCT02035371.

Authors+Show Affiliations

Diabetes Centre for Children and Adolescents, Kinder- und Jugendkrankenhaus AUF DER BULT, Hannover, Germany.Diabetes Centre for Children and Adolescents, Kinder- und Jugendkrankenhaus AUF DER BULT, Hannover, Germany.Diabetes Centre for Children and Adolescents, Kinder- und Jugendkrankenhaus AUF DER BULT, Hannover, Germany.Biostatistics, Novo Nordisk A/S, Søborg, Denmark.Diabetes Centre for Children and Adolescents, Kinder- und Jugendkrankenhaus AUF DER BULT, Hannover, Germany.Clinical Pharmacology, Novo Nordisk A/S, Søborg, Denmark.

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

28165180

Citation

Fath, Maryam, et al. "Faster-acting Insulin Aspart Provides Faster Onset and Greater Early Exposure Vs Insulin Aspart in Children and Adolescents With Type 1 Diabetes Mellitus." Pediatric Diabetes, vol. 18, no. 8, 2017, pp. 903-910.
Fath M, Danne T, Biester T, et al. 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.
Fath, M., Danne, T., Biester, T., Erichsen, L., Kordonouri, O., & Haahr, H. (2017). Faster-acting insulin aspart provides faster onset and greater early exposure vs insulin aspart in children and adolescents with type 1 diabetes mellitus. Pediatric Diabetes, 18(8), pp. 903-910. doi:10.1111/pedi.12506.
Fath M, et al. 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. PubMed PMID: 28165180.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Faster-acting insulin aspart provides faster onset and greater early exposure vs insulin aspart in children and adolescents with type 1 diabetes mellitus. AU - Fath,Maryam, AU - Danne,Thomas, AU - Biester,Torben, AU - Erichsen,Lars, AU - Kordonouri,Olga, AU - Haahr,Hanne, Y1 - 2017/02/06/ PY - 2016/09/20/received PY - 2017/01/06/revised PY - 2017/01/06/accepted PY - 2017/2/7/pubmed PY - 2018/7/13/medline PY - 2017/2/7/entrez KW - adolescents KW - children KW - pharmacodynamics KW - pharmacokinetics KW - type 1 diabetes mellitus SP - 903 EP - 910 JF - Pediatric diabetes JO - Pediatr Diabetes VL - 18 IS - 8 N2 - BACKGROUND: Faster-acting insulin aspart (faster aspart) is insulin aspart (IAsp) in a new formulation with additional excipients (L-arginine and niacinamide). In adults, faster aspart provides faster onset and greater early exposure and action vs IAsp. AIM: This randomized, double-blind, 2-period crossover trial investigated the pharmacological properties of faster aspart vs IAsp in 12 children (6-11 years), 13 adolescents (12-17 years), and 15 adults (18-64 years) with type 1 diabetes mellitus. METHODS: Subjects received 0.2 U/kg subcutaneous dosing (mean of 8.3, 12.8, and 15.6 U, respectively) immediately prior to a standardized meal (17.3 g carbohydrate/100 mL; amount adjusted by body weight). RESULTS: Consistently across age groups, onset of appearance occurred approximately twice-as-fast (5-7 minutes earlier) and early exposure (AUCIAsp,0-30min ; area under the IAsp curve from 0 to 30 minutes) was greater (by 78%-147%) for faster aspart vs IAsp, with no treatment differences in total exposure (AUCIAsp,0-t) or maximum concentration (C max). Two-hour postmeal plasma glucose excursion was reduced for faster aspart vs IAsp (although only reaching statistical significance in children). In accordance with the absolute dose administered for each age group, AUCIAsp,0-t for faster aspart was lower in children (estimated ratio children/adults [95% confidence interval]: 0.59 [0.50;0.69], P < .001) and adolescents (0.78 [0.67;0.90], P = .002) vs adults. No age group differences were seen in C max (0.91 [0.70;1.17], P = .445, and 0.99 [0.77;1.26], P = .903). The age effect on AUCIAsp,0-t and C max did not differ statistically significantly between treatments. Faster aspart and IAsp were well-tolerated. CONCLUSION: The current findings in children and adolescents suggest a potential for faster aspart to improve postprandial glycemia over current rapid-acting insulins also in younger age groups. http://ClinicalTrials.gov identifier: NCT02035371. SN - 1399-5448 UR - https://www.unboundmedicine.com/medline/citation/28165180/Faster_acting_insulin_aspart_provides_faster_onset_and_greater_early_exposure_vs_insulin_aspart_in_children_and_adolescents_with_type_1_diabetes_mellitus_ L2 - https://doi.org/10.1111/pedi.12506 DB - PRIME DP - Unbound Medicine ER -