Similar pharmacokinetics and pharmacodynamics of a new biosimilar and reference insulin aspart in healthy Chinese males.
Adult
Asian People
Biosimilar Pharmaceuticals
/ pharmacokinetics
Blood Glucose
/ drug effects
Cross-Over Studies
Drug Combinations
Glucose Clamp Technique
/ methods
Humans
Hypoglycemic Agents
/ pharmacokinetics
Insulin Aspart
/ pharmacokinetics
Insulin, Long-Acting
/ pharmacokinetics
Male
Young Adult
Journal
Scientific reports
ISSN: 2045-2322
Titre abrégé: Sci Rep
Pays: England
ID NLM: 101563288
Informations de publication
Date de publication:
04 05 2021
04 05 2021
Historique:
received:
02
09
2020
accepted:
19
03
2021
entrez:
5
5
2021
pubmed:
6
5
2021
medline:
25
2
2023
Statut:
epublish
Résumé
Insulin aspart (IAsp) is one of the main therapies used to control blood glucose after a meal. This study aimed to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of 2 rapid-acting IAsp products: a new IAsp biosimilar (RD10046) and NovoRapid. In a single-center, randomized, single-dose, 2-period, crossover, euglycemic clamp study (registry number: CTR20180517, registration date: 2018-05-30), healthy Chinese males were randomized to receive 0.2 U/kg of the IAsp biosimilar RD10046 and NovoRapid under fasted conditions on two separate occasions. PK and PD were assessed for up to 10 h. Of the 30 randomized subjects, all 30 completed both treatment periods. The PK (area under the curve [AUC] of total IAsp; maximum observed IAsp concentration [C
Identifiants
pubmed: 33947913
doi: 10.1038/s41598-021-88782-8
pii: 10.1038/s41598-021-88782-8
pmc: PMC8096952
doi:
Substances chimiques
Biosimilar Pharmaceuticals
0
Blood Glucose
0
Drug Combinations
0
Hypoglycemic Agents
0
Insulin, Long-Acting
0
insulin degludec, insulin aspart drug combination
0
Insulin Aspart
D933668QVX
Types de publication
Clinical Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
9495Commentaires et corrections
Type : ErratumIn
Références
Listed, N. A. Insulin aspart. Asp-B28 NovoRapid. Drugs R D 2, 103–106 (1999).
doi: 10.2165/00126839-199902020-00004
Whittingham, J. L., Edwards, D. J., Antson, A. A., Clarkson, J. M. & Dodson, G. G. Interactions of phenol and m-cresol in the insulin hexamer, and their effect on theassociation properties of B28 pro → asp insulin analogues. Biochemistry 37, 11516–11523 (1998).
doi: 10.1021/bi980807s
Mudaliar, S. R. et al. Insulin aspart (B28 asp-insulin): A fast-acting analog of human insulin: absorption kinetics and action profile compared with regular human insulin in healthy nondiabetic subjects. Diabetes Care 22, 1501–1506. https://doi.org/10.2337/diacare.22.9.1501 (1999).
doi: 10.2337/diacare.22.9.1501
Nosek, L. et al. Insulin aspart has a shorter duration of action than human insulin over a wide dose-range. Diabetes Obes. Metab. 15, 77–83. https://doi.org/10.1111/j.1463-1326.2012.01677.x (2013).
doi: 10.1111/j.1463-1326.2012.01677.x
Ma, Z. et al. A comparison of pharmacokinetics and pharmacodynamics of insulin aspart, biphasic insulin aspart 70, biphasic insulin aspart 50, and human insulin: a randomized, quadruple crossover study. Diabetes Technol. Ther. 14, 589–595. https://doi.org/10.1089/dia.2011.0299 (2012).
doi: 10.1089/dia.2011.0299
Agency, E. M. Guideline on non‐clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues. (2015).
Food and Drug Administration. Guidance for industry: statistical approaches to establishing bioequivalence. (2001).
Food and Drug Administration. Guidance for industry: bioavailability and bioequivalence studies submitted in NDAs or INDs-general considerations-draft guidance. (2014).
China Food and Drug Administration. Draft Guideline on Development and Evaluation of Biosimilars (Chinese Version). (2014).
Heise, T. et al. Euglycaemic glucose clamp: What it can and cannot do, and how to do it. Diabetes Obes. Metab. 18, 962–972 (2016).
doi: 10.1111/dom.12703
Andres, R., Swerdloff, R., Pozefsky, T., Coleman, D. & Coleman, D. Manual feedback technique for the control of blood glucose concentration. Automation in Analytical Chemistry (1966).
DeFronzo, R. A., Tobin, J. D. & Andres, R. Glucose clamp technique: a method for quantifying insulin secretion and resistance. Am. J. Physiol. 237, E214-223. https://doi.org/10.1152/ajpendo.1979.237.3.E214 (1979).
doi: 10.1152/ajpendo.1979.237.3.E214
Becker, R. H. A. Pharmacodynamic Evaluation: Diabetes Methodologies (Springer, 2011).
Bequette, B. W. Glucose clamp algorithms and insulin time-action profiles. J. Diabetes Sci. Technol. 3, 1005–1013. https://doi.org/10.1177/193229680900300503 (2009).
doi: 10.1177/193229680900300503
pubmed: 2769898
pmcid: 2769898
Linnebjerg, H. et al. Comparison of the pharmacokinetics and pharmacodynamics of LY2963016 insulin glargine and EU- and US-approved versions of lantus insulin glargine in healthy subjects: Three randomized euglycemic clamp studies. Diabetes Care 38, 2226–2233. https://doi.org/10.2337/dc14-2623 (2015).
doi: 10.2337/dc14-2623
Benesch, C., Heise, T., Klein, O., Heinemann, L. & Arnolds, S. How to assess the quality of glucose clamps? Evaluation of clamps performed with ClampArt, a novel automated clamp device. J. Diabetes Sci. Technol. 9, 792–800. https://doi.org/10.1177/1932296815576957 (2015).
doi: 10.1177/1932296815576957
pubmed: 4525648
pmcid: 4525648
Kapitza, C., Nosek, L., Schmider, W., Teichert, L. & Nowotny, I. Single-dose euglycemic clamp study demonstrating pharmacokinetic and pharmacodynamic similarity between SAR341402 insulin aspart and US- and EU-approved versions of insulin aspart in subjects with type 1 diabetes. Diabetes Technol. Ther. 22, 278–284. https://doi.org/10.1089/dia.2019.0351 (2020).
doi: 10.1089/dia.2019.0351
pubmed: 7104901
pmcid: 7104901
Leohr, J. et al. Pharmacokinetic and glucodynamic responses of ultra rapid lispro vs lispro across a clinically relevant range of subcutaneous doses in healthy subjects. Clin. Ther. 42, 1762–1777. https://doi.org/10.1016/j.clinthera.2020.07.005 (2020).
doi: 10.1016/j.clinthera.2020.07.005
Bhatia, A. et al. Comparative evaluation of pharmacokinetics and pharmacodynamics of insulin glargine (Glaritus((R))) and Lantus((R)) in healthy subjects: a double-blind, randomized clamp study. Acta Diabetol. 55, 461–468. https://doi.org/10.1007/s00592-018-1113-3 (2018).
doi: 10.1007/s00592-018-1113-3
Heinemann, L., Weyer, C., Rauhaus, M., Heinrichs, S. & Heise, T. Variability of the metabolic effect of soluble insulin and the rapid-acting insulin analog insulin aspart. Diabetes Care 21, 1910–1914. https://doi.org/10.2337/diacare.21.11.1910 (1998).
doi: 10.2337/diacare.21.11.1910
Heinemann, L., Kapitza, C., Starke, A. A. & Heise, T. Time-action profile of the insulin analogue B28Asp. Diabet Med. 13, 683–684. https://doi.org/10.1002/(SICI)1096-9136(199607)13:7%3c683::AID-DIA144%3e3.0.CO;2-1 (1996).
doi: 10.1002/(SICI)1096-9136(199607)13:7<683::AID-DIA144>3.0.CO;2-1
Engwerda, E. E. C., Tack, C. J. & de Galan, B. E. A comparison of the pharmacodynamic profiles of jet-injected regular human insulin versus conventionally administered insulin aspart in healthy volunteers. Diabetes Res. Clin. Pract. 121, 86–90. https://doi.org/10.1016/j.diabres.2016.09.001 (2016).
doi: 10.1016/j.diabres.2016.09.001
Heise, T. et al. Faster-acting insulin aspart: earlier onset of appearance and greater early pharmacokinetic and pharmacodynamic effects than insulin aspart. Diabetes Obes. Metab. 17, 682–688. https://doi.org/10.1111/dom.12468 (2015).
doi: 10.1111/dom.12468
pubmed: 5054830
pmcid: 5054830
Heise, T. et al. Pharmacokinetic and pharmacodynamic properties of faster-acting insulin aspart versus insulin aspart across a clinically relevant dose range in subjects with type 1 diabetes mellitus. Clin. Pharmacokinet. 56, 649–660. https://doi.org/10.1007/s40262-016-0473-5 (2017).
doi: 10.1007/s40262-016-0473-5
Heise, T., Eckers, U., Kanc, K., Nielsen, J. N. & Nosek, L. The pharmacokinetic and pharmacodynamic properties of different formulations of biphasic insulin aspart: A randomized, glucose clamp, crossover study. Diabetes Technol. Ther. 10, 479–485. https://doi.org/10.1089/dia.2008.0019 (2008).
doi: 10.1089/dia.2008.0019
Zhang, Y., Huo, M., Zhou, J. & Xie, S. PKSolver: An add-in program for pharmacokinetic and pharmacodynamic data analysis in Microsoft Excel. Comput. Methods Programs Biomed. 99, 306–314. https://doi.org/10.1016/j.cmpb.2010.01.007 (2010).
doi: 10.1016/j.cmpb.2010.01.007