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Lyumjev™ (insulin lispro – aabc) injection100 units/mL, 200 units/mL
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
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
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
In this study, Lyumjev showed
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 ().2
The early PPG profile following Lyumjev administration more closely matched that of healthy subjects compared with IL-100 ().2
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.
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.
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