open access

Vol 7, No 6 (2018)
Pharmaceutical news
Published online: 2019-01-07
Get Citation

New faster-acting insulin Fiasp® — do we need a new meal-time insulin?

Katarzyna Cypryk, Anna Wyrębska-Niewęgłowska
DOI: 10.5603/DK.2018.0031
·
Clinical Diabetology 2018;7(6):282-286.

open access

Vol 7, No 6 (2018)
Pharmaceutical news
Published online: 2019-01-07

Abstract

Studies aiming at improving the treatment of patients on insulin therapy are conducted bidirectionally. On the one hand, there are attempts to find modified insulin that acts even faster and has shorter effect than currently used short-acting insulin analogs, and on the other hand researchers work to develop more stable basal insulins. Fiasp® is one of the new developments in this field. Addition of two excipients — niacinamide and L-arginine — resulted in faster hypoglycemic effect of insulin aspart while maintaining the stability of drug formulation. Clinical trials assessing pharmacokinetic parameters of Fiasp® showed a 2 times faster onset of action (4 vs. 9 min), 2 times higher exposure to insulin 30 minutes after its administration and 74% more hypoglycemic activity during the first 30 minutes following subcu­taneous injection. Clinical trials of Fiasp® were conducted under the acronym Onset. Overall, these studies included over 3,000 patients with diabetes, both type 1 and type 2. In patients with type 1 diabetes (DM1) comparable or better diabetes control was observed in the Fiasp® groups compared with groups treated with Novorapid, with significantly lower blood glucose levels in the early postprandial period. It has also been demon­strated that administration of insulin Fiasp® within 20 min of the beginning of the meal was associated with comparable results to Novorapid administered before the meal. Fiasp® is commercially available in Poland, but it is not yet widely used due to the high price and no reimburse­ment from NFZ.

Abstract

Studies aiming at improving the treatment of patients on insulin therapy are conducted bidirectionally. On the one hand, there are attempts to find modified insulin that acts even faster and has shorter effect than currently used short-acting insulin analogs, and on the other hand researchers work to develop more stable basal insulins. Fiasp® is one of the new developments in this field. Addition of two excipients — niacinamide and L-arginine — resulted in faster hypoglycemic effect of insulin aspart while maintaining the stability of drug formulation. Clinical trials assessing pharmacokinetic parameters of Fiasp® showed a 2 times faster onset of action (4 vs. 9 min), 2 times higher exposure to insulin 30 minutes after its administration and 74% more hypoglycemic activity during the first 30 minutes following subcu­taneous injection. Clinical trials of Fiasp® were conducted under the acronym Onset. Overall, these studies included over 3,000 patients with diabetes, both type 1 and type 2. In patients with type 1 diabetes (DM1) comparable or better diabetes control was observed in the Fiasp® groups compared with groups treated with Novorapid, with significantly lower blood glucose levels in the early postprandial period. It has also been demon­strated that administration of insulin Fiasp® within 20 min of the beginning of the meal was associated with comparable results to Novorapid administered before the meal. Fiasp® is commercially available in Poland, but it is not yet widely used due to the high price and no reimburse­ment from NFZ.

Get Citation

Keywords

Fiasp®, type 1 and 2 diabetes, niacinamide, basal insulin, short-acting insulin

About this article
Title

New faster-acting insulin Fiasp® — do we need a new meal-time insulin?

Journal

Clinical Diabetology

Issue

Vol 7, No 6 (2018)

Pages

282-286

Published online

2019-01-07

DOI

10.5603/DK.2018.0031

Bibliographic record

Clinical Diabetology 2018;7(6):282-286.

Keywords

Fiasp®
type 1 and 2 diabetes
niacinamide
basal insulin
short-acting insulin

Authors

Katarzyna Cypryk
Anna Wyrębska-Niewęgłowska

References (22)
  1. Results from Two Phase 3 Studies Show Lilly's Ultra Rapid Lispro (URLi) Met Primary Efficacy Endpoint in People with Type 1 and Type 2 Diabetes. https://investor.lilly.com/news-releases/news-release-details/results-two-phase-3-studies-show-lillys-ultra-rapid-lispro-urli.
  2. Charakterystyka Produktu Leczniczego Novorapid. https://ec.europa.eu/health/documents/community-register/2017/20170918138961/anx_138961_pl.pdf.
  3. Charakterystyka Produktu Leczniczego Apidra. https://ec.europa.eu/health/documents/community-register/2017/20170803138606/anx_138606_pl.pdf.
  4. Charakterystyka Produktu Leczniczego Humalog. https://ec.europa.eu/health/documents/community-register/2017/20170719138234/anx_138234_pl.pdf.
  5. Biester T, Kordonouri O, Danne T. Pharmacological Properties of Faster-Acting Insulin Aspart. Curr Diab Rep. 2017; 17(11): 101.
  6. US Food and Drug Administration. Inactive ingredient search for approved drug products. http://www.accessdata.fda.gov/scripts/ cder/iig/index.cfm. Accessed 26 Jan 2017.
  7. Buckley ST, Jeppesen CB, Olsen HB, et al. Faster acting insulin aspart: towards an understunding of the mechanism(s) of action of nicotinamide. Diabetes. 2015; 54(1): 1024.
  8. 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.
  9. Heise T, Stender-Petersen K, Hövelmann U, 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. 2017; 56(6): 649–660.
  10. Heise T, Hövelmann U, Zijlstra E, et al. A Comparison of Pharmacokinetic and Pharmacodynamic Properties Between Faster-Acting Insulin Aspart and Insulin Aspart in Elderly Subjects with Type 1 Diabetes Mellitus. Drugs Aging. 2017; 34(1): 29–38.
  11. Heise T, Hövelmann U, Brøndsted L, et al. Faster-acting insulin aspart: earlier onset of appearance and greater early pharmacokinetic and pharmacodynamic effects than insulin aspart. Diabetes Obes Metab. 2015; 17(7): 682–688.
  12. Heise T, Pieber TR, Danne T, et al. A Pooled Analysis of Clinical Pharmacology Trials Investigating the Pharmacokinetic and Pharmacodynamic Characteristics of Fast-Acting Insulin Aspart in Adults with Type 1 Diabetes. Clin Pharmacokinet. 2017; 56(5): 551–559.
  13. Charakterystyka Produktu Leczniczego. https://ec.europa.eu/health/documents/community-register/2017/20170109136674/anx_136674_pl.pdf.
  14. Shiramoto M, Nishida T, Hansen AK, et al. Fast-acting insulin aspart in Japanese patients with type 1 diabetes: Faster onset, higher early exposure and greater early glucose-lowering effect relative to insulin aspart. J Diabetes Investig. 2018; 9(2): 303–310.
  15. Heise T, Zijlstra E, Nosek L, et al. Pharmacological properties of faster-acting insulin aspart vs insulin aspart in patients with type 1 diabetes receiving continuous subcutaneous insulin infusion: A randomized, double-blind, crossover trial. Diabetes Obes Metab. 2017; 19(2): 208–215.
  16. Scientific poster session. Neuroradiology. 2008; 50(S1): 79–131.
  17. Zijlstra E, Demissie M, Graungaard T, et al. Investigation of Pump Compatibility of Fast-Acting Insulin Aspart in Subjects With Type 1 Diabetes. J Diabetes Sci Technol. 2018; 12(1): 145–151.
  18. Klonoff DC, et al. Diabetes Technol Ther. 2018; ATTD D8-0460 onset 5.
  19. Mathieu C, Bode BW, Franek E, et al. Efficacy and safety of fast-acting insulin aspart in comparison with insulin aspart in type 1 diabetes (onset 1): A 52-week, randomized, treat-to-target, phase III trial. Diabetes Obes Metab. 2018; 20(5): 1148–1155.
  20. Bowering K, Case C, Harvey J, et al. Faster Aspart Versus Insulin Aspart as Part of a Basal-Bolus Regimen in Inadequately Controlled Type 2 Diabetes: The onset 2 Trial. Diabetes Care. 2017; 40(7): 951–957.
  21. Rodbard HW, Tripathy D, Vidrio Velázquez M, et al. Adding fast-acting insulin aspart to basal insulin significantly improved glycaemic control in patients with type 2 diabetes: A randomized, 18-week, open-label, phase 3 trial (onset 3). Diabetes Obes Metab. 2017; 19(10): 1389–1396.
  22. Hövelmann U, Heise T, Nosek L, et al. Pharmacokinetic Properties of Fast-Acting Insulin Aspart Administered in Different Subcutaneous Injection Regions. Clin Drug Investig. 2017; 37(5): 503–509.

Important: This website uses cookies. More >>

The cookies allow us to identify your computer and find out details about your last visit. They remembering whether you've visited the site before, so that you remain logged in - or to help us work out how many new website visitors we get each month. Most internet browsers accept cookies automatically, but you can change the settings of your browser to erase cookies or prevent automatic acceptance if you prefer.

 

Wydawcą serwisu jest  "Via Medica sp. z o.o." sp.k., ul. Świętokrzyska 73, 80–180 Gdańsk

tel.:+48 58 320 94 94, faks:+48 58 320 94 60, e-mail:  viamedica@viamedica.pl