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): Jämförelse med snabbverkande insulinanaloger

I en jämförande studie hade Lyumjev den snabbaste absorptionen och den lägsta PPG-förändringen över tid jämfört med IL-100, NovoRapid och Fiasp hos patienter med T1DM.

URLi - Phase 1 Comparison Study With Fiasp

The phase 1 head-to-head study was a randomized, double-blind, 4-period, crossover, PK/GD study in patients with T1DM.1 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.1

Methods

A healthy cohort of 12 subjects, which approximately matched the cohort of patients with T1DM with regard to the mean BMI and age, was included with the intention of characterizing the insulin secretory and glucose response to the standardized MMTT with normal physiology.1,2

The study was powered to demonstrate the PK differences between URLi (LY900014) and IL-100. Ninety-five percent of power was used to demonstrate a 2-fold increase in the serum insulin lispro AUC(0-30min) between URLi (LY900014) and IL-100.2

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.2

The secondary objectives of the comparison study were to

  • characterize the PK profiles of URLi (LY900014), IL-100, NovoRapid, and Fiasp after a single dose in patients with T1DM

  • evaluate the differences in GD between URLi (LY900014) and IL-100 after a single dose in patients with T1DM, and 

  • characterize the GD response to URLi (LY900014), IL-100, NovoRapid, and Fiasp, as assessed by the MMTT, in patients with T1DM.2

Results

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 (Figure 1).1,3

Figure 1. Insulin Absorption After Subcutaneous Injection of Rapid or Ultra Rapid Insulins in Patients With T1DM.1,3

Abbreviations: Aspart = insulin aspart; Fiasp = Fiasp® (insulin aspart injection) 100 units/mL; IL-100 = Humalog® (insulin lispro injection) 100 units/mL; NovoRapid = NovoRapid® (insulin aspart injection) 100 units/mL; T1DM = type 1 diabetes mellitus; URLi = ultra rapid lispro.

In this study, URLi (LY900014) showed a numerically greatest reduction of PPG excursions compared with all insulins tested, with a significant (p<.05) improvement in PPG excursions vs IL-100 and NovoRapid (Figure 2).1

Figure 2. Postprandial Glucose Excursions During MMTT After Subcutaneous injection of Rapid or Ultra Rapid Insulins in Patients With T1DM1

Abbreviations: Fiasp = Fiasp® (insulin aspart injection) 100 units/mL; IL-100 = Humalog® (insulin lispro injection) 100 units/mL; MMTT = mixed-meal tolerance test; NovoRapid = NovoRapid® (insulin aspart injection) 100 units/mL; T1DM = type 1 diabetes mellitus: URLi = ultra rapid lispro.

The early PPG profile following URLi (LY900014) administration more closely matched that of healthy subjects compared with IL-100 (Figure 3).1

Figure 3. Postprandial Glucose Excursions Change from Baseline During MMTT After Subcutaneous Injection of Rapid and Ultra Rapid Insulins in Patients With T1DM Compared With Healthy Subjects1

Fiasp = Fiasp® (insulin aspart injection) 100 units/mL; IL-100 = Humalog® (insulin lispro injection) 100 units/mL; MMTT = mixed-meal tolerance test; NovoRapid = NovoRapid® (insulin aspart injection) 100 units/mL; T1DM = type 1 diabetes mellitus; URLi = ultra rapid lispro.

During the MMTT, the hypoglycemic profile was similar between insulin groups.1

References

1. Heise 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

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

3. Heise 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

AUC(0-30min) = area under the curve  from 0 to 30 minutes after administration

BMI = body mass index

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

GD = glucodynamic

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

MMTT = mixed-meal tolerance test

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

PK = pharmacokinetic

PPG = postprandial glucose

SC = subcutaneous

T1DM = type 1 diabetes mellitus

URLi = ultra rapid lispro

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Datum fӧr senaste ӧversyn 2019 M08 06


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