Lyumjev™ (insulin lispro – aabc) injection

100 units/mL, 200 units/mL

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LYUMJEV™ (insulin lispro-aabc): Comparison With Rapid Insulin Analogs

In a head-to-head comparison study, Lyumjev demonstrated the fastest absorption and the lowest PPG excursions compared with IL-100, NovoRapid, and Fiasp in patients with T1DM.

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Lyumjev - 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, Lyumjev and IL-100, and
  • 2 formulations of insulin aspart, Fiasp and NovoRapid.2

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 Lyumjev 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 Lyumjev and IL-100.1

The primary objective of the head-to-head comparison study was to evaluate the differences in PK between Lyumjev and IL-100 following a single dose in patients with T1DM.1

The secondary objectives of the comparison study were to

  • characterize the PK profiles of Lyumjev, IL-100, NovoRapid, and Fiasp after a single dose in patients with T1DM
  • evaluate the differences in GD between Lyumjev and IL-100 after a single dose in patients with T1DM, and 
  • characterize the GD response to Lyumjev, IL-100, NovoRapid, and Fiasp, as assessed by the MMTT, in patients with T1DM.1

Results

In this study, Lyumjev showed 

Insulin Absorption After Subcutaneous Injection of Rapid or Ultra Rapid Insulins in Patients With T1DM2,3

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

In this study, Lyumjev 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 (Postprandial Glucose Excursions During MMTT After Subcutaneous injection of Rapid or Ultra Rapid Insulins in Patients With T1DM).2

Postprandial Glucose Excursions During MMTT After Subcutaneous injection of Rapid or Ultra Rapid Insulins in Patients With T1DM2

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

The early PPG profile following Lyumjev administration more closely matched that of healthy subjects compared with IL-100 (Postprandial Glucose Excursions Change from Baseline During MMTT After Subcutaneous Injection of Rapid and Ultra Rapid Insulins in Patients With T1DM Compared With Healthy Subjects).2

Postprandial Glucose Excursions Change from Baseline During MMTT After Subcutaneous Injection of Rapid and Ultra Rapid Insulins in Patients With T1DM Compared With Healthy Subjects2

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

During the MMTT, the hypoglycemic profile was similar between insulin groups.2

More detailed information of the head-to-head comparison study between Lyumjev and other rapid insulins can be accessed in the comparison with rapid insulin analogs video.

References

The published reference below is available by contacting 1-800-LillyRx (1-800-545-5979).

1Data on file, Eli Lilly and Company and/or one of its subsidiaries.

2Heise 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. Diabetes. 2019;68(suppl 1). American Diabetes Association abstract 1112-P. https://doi.org/10.2337/db19-1112-P

3Heise 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 time 0 to 30 minutes

BMI = body mass index

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

GD = glucodynamic

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

Lyumjev = Lyumjev™ (insulin lispro-aabc)

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

Date of Last Review: August 06, 2019


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