Lyumjev ® (insulin lispro)

För fullständig produktresumé för Lyumjev se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Lyumjev® ▼ (insulin lispro): Formulering jämfört med Fiasp®

URLi (LY900014) innehåller 2 hjälpämnen: citrat och treprostinil för att påskynda dess absorption, och Fiasp innehåller nikotinamid för en snabbare initial absorption jämfört med NovoRapid.

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Formulation Compared With Fiasp®

The formulation of URLi (LY900014) contains citrate and treprostinil that act to accelerate the absorption of insulin lispro.1-4

Citrate is a GRAS excipient used in multiple pharmaceutical formulations.5

Treprostinil is the active ingredient in approved products with well-known safety profiles. In the URLi (LY900014) formulation, a microdose of treprostinil (1 mcg/mL) is used as excipient. After dosing with URLi (LY900014), treprostinil systemic circulating levels were undetectable up to the dose of 400 ng; equivalent to a 40 units dose of URLi (LY900014), and no systemic effects were observed.6

Fiasp is a mealtime insulin aspart formulation in which the addition of nicotinamide (vitamin B3) results in a faster initial absorption of insulin compared to NovoRapid.7

Pharmacokinetic and Glucodynamic Comparison Study

In this comparison study, the Fiasp formulation includes the excipients of NovoRapid, and also nicotinamide (vitamine B3) that results in a faster initial absorption of insulin compared to NovoRapid.7

The phase 1 head-to-head study was a randomized, double-blind, 4-period, crossover, PK/GD study in patients with T1DM.8 Treatments were administered as a single individualized SC dose just before a standardized MMTT to compare

  • 2 formulations of insulin lispro, URLi (LY900014) and IL-100, and
  • 2 formulations of insulin aspart, Fiasp and NovoRapid.8

The primary objective of the head-to-head comparison study was to evaluate the differences in PK between URLi (LY900014) and IL-100 following a single dose in patients with T1DM.6

In this study, URLi (LY900014) showed 

  • the fastest insulin absorption
  • the greatest reduction in late insulin exposure, and
  • the shortest exposure duration compared with IL-100, NovoRapid, Fiasp.8,9

References

1Michael MD, Zhang C, Siesky AM, et al. Exploration of the mechanism of accelerated absorption for a novel insulin lispro formulation [abstract]. Diabetes. 2017;66(suppl 1):A250. http://dx.doi.org/10.2337/db17-890-1488

2Paavola CD, Sperry AE, Hansen RJ, et al. A stable, hexameric, ultra rapid insulin formulation containing citrate [abstract]. Diabetes. 2017;66(suppl 1):A254. http://dx.doi.org/10.2337/db17-890-1488

3Pratt E, Leohr J, Heilmann C, et al. Treprostinil causes local vasodilation, is well tolerated, and results in faster absorption of insulin lispro [abstract]. Diabetes. 2017;66(suppl 1):A253. http://dx.doi.org/10.2337/db17-890-1488

4Lyumjev [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

5US Food and Drugs Administration (FDA)/Code of Federal Regulations (CFR) Title 21: Part 184. Direct food substances affirmed as generally recognized as safe. Updated April 1, 2019. Accessed January 10, 2020. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=184

6Data on file, Eli Lilly and Company and/or one of its subsidiaries.

7Fiasp [summary of product characteristics]. Novo Nordisk A/S, Denmark.

8Heise T, Linnebjerg H, Cao D, et al. Ultra rapid lispro (URLi) lowers postprandial glucose (PPG) and more closely matches normal physiological glucose response compared with other rapid insulin analogs [abstract 1112-P]. Diabetes. 2019;68(suppl 1). https://doi.org/10.2337/db19-1112-P

9Heise T, Linnebjerg H, Cao D, et al. Ultra rapid lispro lowers postprandial glucose (PPG) and more closely matches normal physiological glucose response compared to other rapid insulin analogs. Poster presented at: 79th Scientific Sessions of the American Diabetes Association; June 8, 2019; San Francisco, CA.

Glossary

Fiasp = Fiasp® (insulin aspart injection) 100 units/mL

GRAS = generally recognized as safe

IL-100 = Humalog® (insulin lispro injection) 100 units/mL

Lilly = Eli Lilly and Company

NovoRapid = NovoRapid® (insulin aspart injection) 100 units/mL

PK = pharmacokinetic

T1DM = type 1 diabetes mellitus

URLi = ultra rapid lispro

Datum fӧr senaste ӧversyn 2020 M01 10


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