Lyumjev ® (insulin lispro)

För fullständig produktresumé för Lyumjev se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Lyumjev® ▼ (insulin lispro): Fas 3-studier

Lyumjev Fas 3-studier om säkerhet och effekt inleddes i juli 2017 och slutfördes under Q3 2018. En andra fas 3-pumpstudie startade i februari 2019 och slutfördes under Q1 2020. Fas 3 PRONTO-Peds bör slutföras under Q2 2021.

Detailed Information

Lilly has moved the clinical development of URLi (LY900014) into phase 3 studies that began in July 2017.1,2

The phase 3 clinical studies compare URLi (LY900014) with IL-100 in the treatment of patients with T1DM or T2DM (Table 1).1-5 

The efficacy and safety studies, PRONTO-T1D (ITRM) 6-month primary endpoint and PRONTO-T2D (ITRN), along with the study PRONTO-Pump (ITSI), were completed in the third quarter of 2018.1-3 The data of these 3 studies were presented at scientific meetings starting in 2019.6-8

A second phase 3 pump PRONTO-Pump-2 (ITRO) study in patients with T1DM was initiated on February 14, 2019 and was completed in first quarter of 2020.4

A phase 3 clinical study PRONTO-Peds (ITSB) comparing URLi (LY900014) with IL-100 in children and adolescents with T1DM was initiated on March 8, 2019. The study's estimated completion is second quarter 2021.5

Table 1. Phase 3 Studies for URLi (LY900014)

Lilly Study Identifier

ClinicalTrials.gov Identifier 

Official Title 

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

Abbreviations: LY900014 = ultra rapid 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 .

References

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.

Glossary

IL-100 = Humalog® (insulin lispro injection) 100 units/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 = type 1 diabetes mellitus

T2DM = type 2 diabetes mellitus

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.

Datum fӧr senaste ӧversyn 2020 M04 20


Kontakta Medicinsk Information på Lilly

Kontakta oss på telefon

Kontorstid vardagar 9.00-17.00

Eller så kan du

Klicka för att chatta är tillgänglig

Klicka för att chatta är offline

Skriv din fråga till oss