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Lyumjev ® ▼ (insulin lispro)
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What is the incidence of injection site reactions in the Lyumjev® (insulin lispro) pediatric study?
A total of 4.7% patients experienced at least 1 treatment-emergent adverse event of injection site reactions, mild and moderate in severity. Significantly (p<.001) more patients in the Lyumjev mealtime treatment group were impacted.
PRONTO-Peds Study
PRONTO-Peds was a phase 3, prospective, randomized, outpatient, multinational, multicenter, parallel, active-controlled study conducted in children and adolescent patients aged at least 1 to less than 18 years with type 1 diabetes mellitus who were using a multiple-daily-injection (MDI) regimen.1,2
Study Objectives
The efficacy objectives were to test
- the noninferiority of the Lyumjev premeal and postmeal treatment groups with the Humalog mealtime treatment group on glycated hemoglobin (HbA1c) level, and also
- the superiority with respect to the change from baseline to week 26 in HbA1c for Lyumjev compared with Humalog administered as prandial insulin, 0 to 2 minutes prior to the meal.2
The safety analyses including the injection site reactions were conducted on the safety population defined as all randomized patients who received at least 1 dose of the randomly assigned investigational product.2
Injection Site Reaction Incidence Safety
Treatment-emergent injection site reactions were identified using the Medical Dictionary for Regulatory Activities search terms.2
A total of 34 patients (4.7%) experienced ≥1 treatment-emergent adverse event (TEAE) of injection site reactions. The infusion site reactions were all mild and moderate in severity. Significantly (p<.001) more patients in the Lyumjev mealtime treatment group experienced ≥1 injection site reaction TEAE compared with the Humalog treatment group (Treatment-Emergent Injection Site Reactions From Randomization to Safety Follow-up in the PRONTO-Peds Study in Children and Adolescents With Type 1 Diabetes).2
For treatment-emergent injection site reactions related to investigational product, there were
- 20 patients (7.1%) with ≥1 injection site reaction TEAE in the Lyumjev mealtime treatment groups compared with
- 5 patients (1.7%) in the Humalog mealtime treatment group.
In the Lyumjev postmeal treatment group, 4 patients (2.9%) showed ≥1 injection site reaction TEAE (Treatment-Emergent Injection Site Reactions From Randomization to Safety Follow-up in the PRONTO-Peds Study in Children and Adolescents With Type 1 Diabetes).2
Parametersa |
Lyumjev |
Lyumjev |
Humalog |
Subjects with ≥1 TEAE |
22 (7.9) |
4 (2.9) |
8 (2.7) |
Injection site reaction |
11 (3.9)c |
2 (1.4) |
0 (0.0) |
Injection site erythema |
4 (1.4) |
0 (0.0) |
1 (0.3) |
Injection site pain |
4 (1.4) |
1 (0.7) |
0 (0.0) |
Lipohypertrophy |
1 (0.4) |
0 (0.0) |
3 (1.0) |
Lipohypertrophy acquired |
0 (0.0) |
0 (0.0) |
3 (1.0) |
Injection site bruising |
1 (0.4) |
1 (0.7) |
0 (0.0) |
Injection site induration |
0 (0.0) |
0 (0.0) |
2 (0.7) |
Injection site mass |
0 (0.0) |
1 (0.7) |
0 (0.0) |
Injection site pruritus |
1 (0.4) |
0 (0.0) |
0 (0.0) |
Abbreviations: Humalog = Humalog® (insulin lispro) 100 units/mL; Lyumjev = Lyumjev® (insulin lispro) 100 units/mL; TEAE = treatment-emergent adverse event;
PRONTO-Peds = a Prospective, Randomized, double-blind cOmparisoN of LY900014 to humalog with an open-label postprandial LY900014 Treatment grOup in children and adolescents with type 1 diabetes.
aData presented as n (%).
bTreatment given 20 min after the meal.
cp<.001.
Injection Site Reaction Leading to Discontinuation of Investigational Product at Week 26
The adverse events leading to treatment discontinuation were reported by 2 patients (0.7%) in the Lyumjev mealtime treatment groups. One patient reported moderate injection site pain, and the second patient reported mild injection site reaction.2
Appendix: study design
PRONTO-Peds was a 3-treatment group design study that included
Patients included in this study were treated in combination with basal insulin including
- insulin glargine 100 units/mL daily or twice daily
- insulin detemir 100 units/mL daily or twice daily, or
- insulin degludec 100 units/mL daily.2
References
1Wadwa RP, Laffel LM, Franco DR, et al. Glycemic control with ultrarapid lispro (URLi) vs. lispro in children and adolescents with T1D: PRONTO-Peds. Diabetes. 2022;71(suppl 1). American Diabetes Association abstract 38-OR. https://doi.org/10.2337/db22-38-OR
2Data on file, Eli Lilly and Company and/or one of its subsidiaries.
▼ 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.
Date of Last Review: 25 January 2022