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Lyumjev ® ▼ (insulin lispro)
Lyumjev® ▼ (insulin lispro): Local Tolerance of Treprostinil
No patients in the Lyumjev phase 3 PRONTO studies discontinued treatment due to injection site pain. The role of treprostinil in injection site pain is unknown.
In the phase 3 efficacy and safety studies, the incidence of injection site pain was significantly higher in patients treated with Lyumjev compared with those treated with IL-100 (1.2% vs 0.0%, p=.002). Overall, injection site pain was reported in
8 patients (0.7%, p=.06) in the PRONTO-T1D study, and
5 patients (0.7%, p=.031) in the PRONTO-T2D study.1-3
In the PRONTO-Pump study, the incidence of infusion site pain was similar between treatment groups with >90% of the events reported as mild. Infusion site pain was reported in
9 patients (18.4%) in the Lyumjev treatment group, and
1. Blevins T, Zhang Q, Frias JP, et al. Ultra rapid lispro (URLi) improves postprandial glucose (PPG) control vs. Humalog (lispro) in patients with type 2 diabetes (T2D): PRONTO-T2D [abstract 145-OR]. Diabetes. 2019;68(suppl 1). http://dx.doi.org/10.2337/db19-145-OR
3. Klaff LJ, Cao D, Dellva MA, et al. Ultra rapid lispro (URLi) improves postprandial glucose (PPG) control vs. Humalog (lispro) in T1D: PRONTO-T1D study [abstract 144-OR]. Diabetes. 2019;68(suppl 1). http://dx.doi.org/10.2337/db19-144-OR
4. A study of LY900014 and insulin lispro with an external continuous subcutaneous insulin infusion system in adult participants with type 1 diabetes (PRONTO-Pump). ClinicalTrials.gov identifier: NCT03433677. Updated October 8, 2019. Accessed June 23, 2020. https://clinicaltrials.gov/show/NCT03433677
5. Bode BW, Liu R, Hardy TA, Ignaut DA. Compatibility and safety of ultra rapid lispro (URLi) with continuous subcutaneous insulin infusion (CSII) in patients with type 1 diabetes: PRONTO-pump study [abstract]. Diabetologia. 2019;62(suppl 1):S383. http://dx.doi.org/10.1007/s00125-019-4946-6
6. Simonneau G, Barst RJ, Galie N, et al; Treprostinil Study Group. Continuous subcutaneous infusion of treprostinil, a prostacyclin analogue, in patients with pulmonary arterial hypertension: a double-blind, randomized, placebo-controlled trial. Am J Respir Crit Care Med. 2002;165(6):800-804. https://doi.org/10.1164/ajrccm.165.6.2106079
7. Skoro-Sajer N, Lang IM, Harja E, et al. A clinical comparison of slow- and rapid-escalation treprostinil dosing regimens in patients with pulmonary hypertension. Clin Pharmacokinet. 2008;47(9):611-618. http://dx.doi.org/10.2165/00003088-200847090-00004
AE = adverse event
IL-100 = Humalog® (insulin lispro injection) 100 units/mL
PRONTO-Pump = a Prospective, Randomized, double-blind, crossover cOmparison evaluating compatibility and safety of LY900014 and iNsulin lispro with an exTernal cOntinuous subcutaneous insulin infusion system in adult patients with type 1 diabetes
PRONTO-T1D = a Prospective, Randomized, double-blind cOmparison of LY900014 to iNsulin lispro with an open-label postprandial LY900014 Treatment group, in cOmbination with insulin glargine or insulin degludec, in adults with Type 1 Diabetes
PRONTO-T2D = a Prospective, Randomized, double-blind cOmparison of LY900014 to iNsulin lispro, boTh in cOmbination with insulin glargine or insulin degludec in adults with Type 2 Diabetes
URLi = ultra rapid lispro
▼ 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: October 25, 2019