Lyumjev® (Insulin lispro): Phase-3-Studien

Detaillierte Informationen

Lilly hat die klinische Entwicklung von URLi (LY900014) in die Phase-3-Studien , die im Juli 2017 begannen, vorangebracht.^1,2

In klinischen Phase-3-Studien wird URLi (LY900014) mit IL-100 bei der Behandlung von Patienten mit T1DM oder T2DM verglichen (Tabelle 1).^1-5 

Die Wirksamkeits- und Sicherheitsstudien PRONTO-T1D (ITRM) mit 6-monatigem primärem Endpunkt und PRONTO-T2D (ITRN) sowie die Studie PRONTO-Pump (ITSI) wurden im dritten Quartal 2018 abgeschlossen.^1-3 Die Daten dieser drei Studien wurden ab 2019 auf wissenschaftlichen Tagungen vorgestellt.^6-8

Eine zweite Phase-3-Studie zur Anwendung in Insulinpumpen, PRONTO-Pump-2 (ITRO) bei Patienten mit T1DM, wurde am 14. Februar 2019 begonnen und im ersten Quartal 2020 abgeschlossen.⁴

Eine klinische Phase-III-Studie PRONTO-Peds (ITSB) zum Vergleich von URLi (LY900014) mit IL-100 bei Kindern und Jugendlichen mit T1DM wurde am 8. März 2019 eingeleitet. Der Abschluss der Studie wird für das zweite Quartal 2021 erwartet.⁵

Tabelle 1. Phase-3-Studien für URLi (LY900014)

Lilly-Studien-Kennung	ClinicalTrials.gov-Kennung	Offizieller Titel
I8B-MC-ITRM (PRONTO-T1D)1	NCT03214367	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-T1D
I8B-MC-ITRN (PRONTO-T2D)2	NCT03214380	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 PRONTO-T2D
I8B-MC-ITSI (PRONTO-Pump)3	NCT03433677	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-Pump
I8B-MC-ITRO (PRONTO-Pump-2)4	NCT03830281	A prospective, randomized, double-blind comparison of LY900014 to Humalog in adults with type 1 diabetes using continuous subcutaneous insulin infusion  PRONTO-Pump-2
I8B-MC-ITSB (PRONTO-Peds)5	NCT03740919	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  PRONTO-Peds

Abkürzungen: LY900014 = ultraschnelles Insulin lispro; Lilly = Eli Lilly and Company; NCT = National Clinical Trial; 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; 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-Pump-2 = a Prospective, Randomized, double-blind cOmparisoN of LY900014 to humalog in adults with Type 1 diabetes using cOntinuous subcutaneous insulin infusion; 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 .

Referenzen

1. A study of LY900014 in participants with type 1 diabetes (PRONTO-T1D). ClinicalTrials.gov website. https://clinicaltrials.gov/show/NCT03214367. Updated October 4, 2019. Accessed April 20, 2020.

2. A study of LY900014 compared to insulin lispro in participants with type 2 diabetes (PRONTO-T2D). ClinicalTrials.gov website. https://clinicaltrials.gov/show/NCT03214380. Updated March 27, 2020. Accessed April 20, 2020.

3. 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 website. https://clinicaltrials.gov/show/NCT03433677. Updated October 8, 2019. Accessed April 20, 2020.

4. A study comparing LY900014 to insulin lispro (Humalog) in adults with type 1 diabetes using insulin pump therapy (PRONTO-Pump-2). ClinicalTrials.gov website. https://clinicaltrials.gov/ct2/show/NCT03830281. Updated January 21, 2020. Accessed April 20, 2020.

5. A study comparing LY900014 to insulin lispro (Humalog) in children and adolescents with type 1 diabetes (PRONTO-Peds). ClinicalTrials.gov website. https://clinicaltrials.gov/ct2/show/NCT03740919. Updated March 17, 2020. Accessed April 20, 2020.

6. 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

7. 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

8. Blevins T, Zhang Q, Frias JP, et al. Ultra rapid lispro (URLi) improves postprandial glucose control vs. Humalog® (lispro) in patients with type 2 diabetes: PRONTO-T2D study. Talk presented at: 79th Scientific Sessions of the American Diabetes Association; June 9, 2019; San Francisco, CA.

Glossar

IL-100 = Humalog® (Insulin-lispro) 100 Einheiten/ml

Lilly = Eli Lilly and Company

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

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-Pump-2 = a Prospective, Randomized, double-blind cOmparisoN of LY900014 to humalog in adults with Type 1 diabetes using cOntinuous subcutaneous insulin infusion

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

T1DM = Typ 1 Diabetes mellitus

T2DM = Typ 2 Diabetes mellitus 

URLi = ultra rapid lispro