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Lyumjev ® ▼ (insulin lispro)
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What are the safety outcomes in the Lyumjev® (insulin lispro) pediatric study?
Overall, treatment-emergent adverse events (TEAEs) were similar between treatment groups for each preferred term, with the exception of injection site reactions that had a significantly higher frequency in the Lyumjev mealtime treatment group.
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 regimen.1
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.1,2
Safety Outcomes at week 26
The incidence of all treatment-emergent adverse events (TEAEs) reported during the study was similar between the treatment groups (Adverse Events 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 TEAEs |
131 (46.8)c |
52 (37.7)d |
144 (48.3) |
Treatment-related TEAEse |
28 (10.0) |
6 (4.3) |
9 (3.0) |
Deaths |
0 |
0 |
0 |
SAEs |
6 (2.1) |
2 (1.4) |
12 (4.0) |
AEs leading to discontinuation from study |
2 (0.7) |
0 |
0 |
AEs leading to discontinuation from treatment |
2 (0.7) |
0 |
0 |
Abbreviations: AE = adverse event; Humalog = Humalog® (insulin lispro) 100 units/mL; Lyumjev = Lyumjev® (insulin lispro) 100 units/mL; SAE = severe adverse event; 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=.739 vs Humalog.
dp=.039 vs Humalog.
eRelatedness determined by investigator. Patients can be counted in more than 1 category.
Adverse Events by Preferred Term
The frequency of patients with at least 1 TEAE was
- similar between the Lyumjev (46.8%) and Humalog (48.3%) mealtime treatment groups, and
- lower with the Lyumjev postmeal (37.7%) treatment group (The 10 Most Frequent Treatment-emergent Adverse Events per Preferred Terms From Randomization to Week 26 Prior to Discontinuation of Investigational Product in the PRONTO-Peds Study in Children and Adolescents With Type 1 Diabetes). 2
The most frequently reported TEAE was nasopharyngitis (The 10 Most Frequent Treatment-emergent Adverse Events per Preferred Terms From Randomization to Week 26 Prior to Discontinuation of Investigational Product in the PRONTO-Peds Study in Children and Adolescents With Type 1 Diabetes).2
The injection site reaction preferred term was significantly (p<.001) more frequent in patients in the Lyumjev mealtime treatment group (3.9%) compared with the Humalog treatment group (0%) (The 10 Most Frequent Treatment-emergent Adverse Events per Preferred Terms From Randomization to Week 26 Prior to Discontinuation of Investigational Product in the PRONTO-Peds Study in Children and Adolescents With Type 1 Diabetes). All the injection site reactions were characterized as mild or moderate in severity.2
Preferred Terma |
Lyumjev |
Lyumjev |
Humalog |
Subjects with ≥1 TEAEs |
131 (46.8)b |
52 (37.7)c |
144 (48.3) |
Nasopharyngitis |
22 (7.9) |
7 (5.1) |
21 (7.0) |
URTI |
15 (5.4) |
2 (1.4) |
15 (5.0) |
Headache |
12 (4.3) |
3 (2.2) |
12 (4.0) |
Vomiting |
9 (3.2) |
3 (2.2) |
9 (3.0) |
Rhinitis |
6 (2.1) |
4 (2.9) |
9 (3.0) |
Abdominal pain |
5 (1.8) |
3 (2.2) |
7 (2.3) |
Pharyngitis |
8 (2.9) |
3 (2.2) |
4 (1.3) |
Respiratory tract infection |
8 (2.9) |
2 (1.4) |
5 (1.7) |
Injection site reaction |
11 (3.9)d |
2 (1.4) |
0 (0.0) |
Oropharyngeal pain |
5 (1.8) |
3 (2.2) |
5 (1.7) |
Abbreviations: Humalog = Humalog® (insulin lispro) 100 units/mL; Lyumjev = Lyumjev® (insulin lispro) 100 units/mL; TEAE = treatment-emergent adverse event; URTI = upper respiratory tract infection;
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 (%).
bp=.739 vs Humalog.
cp=.039 vs Humalog.
dp<.001 vs Humalog.
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. Efficacy and safety of ultra-rapid lispro versus lispro in children and adolescents with type 1 diabetes: The PRONTO-Peds trial. Diabetes Obes Metab. 2022;1–9. https://doi.org/10.1111/dom.14849
2Data on file, Eli Lilly and Company and/or one of its subsidiaries.
3Wadwa 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
▼ 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