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Lyumjev ® (insulin lispro - aabc) injection
100 units/mL, 200 units/mL
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How does the insulin absorption and the postprandial glycemic excursion of Lyumjev® (insulin lispro) compare with other rapid-acting insulin analogues?-aabc
In a head-to-head comparison study, Lyumjev demonstrated the fastest absorption and the lowest PPG excursions compared with Humalog, NovoRapid, and Fiasp in patients with T1DM.
Lyumjev - Phase 1 Comparison Study With Fiasp
The phase 1 head-to-head study was a randomized, double-blind, 4-period, crossover, pharmacokinetic (PK)/ glucodynamic (GD) study in patients with type 1 diabetes mellitus (T1DM).1 Treatments were administered as a single individualized subcutaneous dose just before a standardized mixed-meal tolerance test (MMTT) to compare
- 2 formulations of insulin lispro, Lyumjev 100 units/mL and Humalog® (insulin lispro injection) 100 units/mL, and
- 2 formulations of insulin aspart, Fiasp® (insulin aspart injection) 100 units/mL and NovoRapid® (insulin aspart injection) 100 units/mL.2
Methods
A healthy cohort of 12 subjects, which approximately matched the cohort of patients with T1DM with regard to the mean body mass index 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 Humalog. Ninety-five percent of power was used to demonstrate a 2-fold increase in the serum insulin lispro area under the curve from time 0 to 30 minutes (AUC(0-30min)) between Lyumjev and Humalog.1
The primary objective of the head-to-head comparison study was to evaluate the differences in PK between Lyumjev and Humalog following a single dose in patients with T1DM.1
The secondary objectives of the comparison study were to
- characterize the PK profiles of Lyumjev, Humalog, NovoRapid, and Fiasp after a single dose in patients with T1DM
- evaluate the differences in GD between Lyumjev and Humalog after a single dose in patients with T1DM, and
- characterize the GD response to Lyumjev, Humalog, NovoRapid, and Fiasp, as assessed by the MMTT, in patients with T1DM.1
Results
In this study, Lyumjev showed
- the fastest insulin absorption
- the greatest reduction in late insulin exposure, and
- the shortest exposure duration compared with Humalog, NovoRapid, Fiasp ().2
In this study, Lyumjev showed a greatest reduction of PPG excursions compared with all insulins tested, with a significant (p<.05) improvement in postprandial glucose excursions versus Humalog and NovoRapid ().2
The early postprandial glucose profile following Lyumjev administration more closely matched that of healthy subjects compared with Humalog ().2
During the mixed-meal tolerance test, the hypoglycemic profile was similar between insulin groups.2
Enclosed Prescribing Information
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
Date of Last Review: July 11, 2022