Lyumjev® Insulin Lispro

Die folgenden Informationen werden als Antwort auf Ihre Anfrage zur Verfügung gestellt und können Informationen über Dosierung, Formulierungen und Bevölkerungsgruppen enthalten, die sich von der Zulassung unterscheiden.

Was sind die Phase 3 Studien zu Lyumjev® (Insulin lispro)?

Phase 3 Sicherheits- und Wirksamkeitsstudien zu Lyumjev begannen Juli 2017 und wurden Q3 2018 abgeschlossen. Die Studie zur Pumpenanwendung begann Februar 2019 und wurde Q1 2020 abgeschlossen. Die PRONTO-Peds Studie wurde Juli 2021 abgeschlossen.

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Phase 3 klinisches Entwicklungsprogramm

In klinischen Phase-3-Studien wird Lyumjev mit Humalog 100 Einheiten/mL (IL-100) bei der Behandlung von Patienten mit Typ 1Diabetes Mellitus (T1DM) oder Typ 2 Diabetes Mellitus (T2DM) verglichen (Phase 3 Studien zu Lyumjev).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 in 20196-8und in 20209-11 auf wissenschaftlichen Tagungen vorgestellt. 

Eine zweite Phase-3-Studie zur Anwendung in Insulinpumpen, PRONTO-Pump-2 (ITRO) bei Patienten mit T1DM, wurde am 14. Februar 2019 begonnen und am 6. Januar 2020 abgeschlossen.4,12

Eine klinische Phase 3 Studie PRONTO-Peds (ITSB) zum Vergleich von Lyumjev mit Humalog 100 Einheiten/mL bei Kindern und Jugendlichen mit T1DM wurde am 8. März 2019 eingeleitet und im Juli 2021 abgeschlossen. Die Daten wurden auf wissenschaftlichen Tagungen in 2022 vorgestellt.13,14

Phase 3 Studien zu Lyumjev

Lilly-Studien-Kennung 

ClinicalTrials.gov Kennung 

Offizieller Titel

I8B-MC-ITRM (PRONTO-T1D)1,15-17

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)2,18

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)3,19

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)4,12

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)13,14

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: Lilly = Eli Lilly und Company; LY900014 = ultraschnelles Insulin lispro; 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

1A study of LY900014 in participants with type 1 diabetes (PRONTO-T1D). ClinicalTrials.gov identifier: NCT03214367. Updated May 1, 2020. Accessed July 25, 2022. https://clinicaltrials.gov/show/NCT03214367

2A study of LY900014 compared to insulin lispro in participants with type 2 diabetes (PRONTO-T2D). ClinicalTrials.gov identifier: NCT03214380. Updated March 27, 2020. Accessed July 25, 2022. https://clinicaltrials.gov/show/NCT03214380

3A 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 July 25, 2022. https://clinicaltrials.gov/show/NCT03433677

4A study comparing LY900014 to insulin lispro (Humalog) in adults with type 1 diabetes using insulin pump therapy (PRONTO-Pump-2). ClinicalTrials.gov identifier: NCT03830281. Updated January 22, 2021. Accessed July 25, 2022. https://clinicaltrials.gov/ct2/show/NCT03830281

5A study comparing LY900014 to insulin lispro (Humalog) in adults with type 1 diabetes using insulin pump therapy (PRONTO-Pump-2). ClinicalTrials.gov identifier: NCT03830281. Updated January 21, 2020. Accessed July 28, 2020. https://clinicaltrials.gov/ct2/show/NCT03830281

6Klaff LJ, Cao D, Dellva MA, et al. Ultra rapid lispro (URLi) improves postprandial glucose (PPG) control vs. Humalog (lispro) in T1D: PRONTO-T1D study. Diabetes. 2019;68(suppl 1). American Diabetes Association abstract 144-OR. https://doi.org/10.2337/db19-144-OR

7Bode BW, Cao D, Liu R, et al. Ultra rapid lispro (URLi) improves postprandial glucose (PPG) control and time in range (TIR) in T1D compared to Humalog® (lispro): PRONTO-T1D continuous glucose monitoring (CGM) sub-study. Diabetes. 2019;68(suppl 1). American Diabetes Association abstract 1089-P. http://dx.doi.org/10.2337/db19-1089-P

8Blevins 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. Diabetes. 2019;68(suppl 1). American Diabetes Association abstract 145-OR. https://doi.org/10.2337/db19-145-OR

9Klaff LJ, Cho JI, Dellva MA, et al. Long-term safety and efficacy of ultra rapid lispro (URLi) in PRONTO-T1D. Diabetes. 2020;69(Suppl 1). American Diabetes Association abstract 232-OR. https://doi.org/10.2337/db20-232-OR

10Bue-Valleskey JM, Cho JIK, Hardy T. The impact of basal insulin type, prandial dosing plan, and baseline postprandial glucose (PPG) on glycemic control after treatment with ultra-rapid lispro (URLi) or Humalog in type 1 diabetes: planned subgroup analyses from PRONTO-T1D. Diabetes. 2020;69(Suppl 1). American Diabetes Association abstract 1044-P. https://doi.org/10.2337/db20-1044-P

11Chang AM, Hardy T, Zhang Q. Effect of age on HbA1c, postprandial glucose (PPG) control, and hypoglycemia in patients with T2D treated with ultra rapid lispro (URLi) or Humalog®: PRONTO-T2D. Diabetes. 2020;69(Suppl 1). American Diabetes Association abstract 1046-P. https://doi.org/10.2337/db20-1046-P

12Warren M, Bode B, Cho JI, et al. Improved postprandial glucose control with ultra rapid lispro versus lispro with continuous subcutaneous insulin infusion in type 1 diabetes: PRONTO-Pump-2. Diabetes Obes Metab. 2021;23(7):1552-1561. https://doi.org/10.1111/dom.14368

13A Study Comparing LY900014 to Insulin Lispro (Humalog) in Children and Adolescents With Type 1 Diabetes (PRONTO-Peds). ClinicalTrials.gov identifier: NCT03740919. Updated January 24, 2022. Accessed July 25, 2022. https://clinicaltrials.gov/ct2/show/NCT03740919

14Wadwa 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

15Klaff L, Cao D, Dellva MA, et al. Ultra rapid lispro improves postprandial glucose control compared with lispro in patients with type 1 diabetes: results from the 26-week PRONTO-T1D study. Diabetes Obes Metab. 2020;22(10):1799-1807. https://doi.org/10.1111/dom.14100

16Malecki MT, Cao D, Liu R, et al. Ultra-rapid lispro improves postprandial glucose control and time in range in type 1 diabetes compared to lispro: PRONTO-T1D continuous glucose monitoring substudy. Diabetes Technol Ther. 2020;22(11):853-860. https://doi.org/10.1089/dia.2020.0129

17Bue-Valleskey J, Klaff L, Cho JI, et al. Long-term efficacy and safety of ultra rapid lispro (URLi) in adults with type 1 diabetes: the PRONTO-T1D extension. Diabetes Ther. 2021;12(2):569-580. https://doi.org/10.1007/s13300-020-00987-8

18Blevins T, Zhang Q, Frias JP, et al; PRONTO-T2D Investigators. Randomized double-blind clinical trial comparing ultra rapid lispro with lispro in a basal-bolus regimen in patients with type 2 diabetes: PRONTO-T2D. Diabetes Care. 2020;43(12):2991-2998. https://doi.org/10.2337/dc19-2550

19Bode BW, Garg SK, Norwood P, et al. Compatibility and safety of ultra rapid lispro with continuous subcutaneous insulin infusion in patients with type 1 diabetes: PRONTO-Pump study. Diabetes Technol Ther. 2021;23(1):41-50. https://doi.org/10.1089/dia.2020.0224

Datum der letzten Prüfung: 25. Juli 2022


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