Lyumjev ® ▼ (insulin lispro)

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What is the incidence of infusion site reactions with Lyumjev®▼ (insulin lispro) in PRONTO-Pump-2 Study?

In the PRONTO-Pump-2 study, the incidence of treatment emergent adverse events (TEAEs) was primarily driven by an increase in infusion site reaction and infusion site pain. The majority of these events (94%) were of mild or moderate severity.

UK_cFAQ_URI091_PRONTO_PUMP_2_STUDY_INFUSION_SITE_REACTION
UK_cFAQ_URI091_PRONTO_PUMP_2_STUDY_INFUSION_SITE_REACTION
en-GB

PRONTO-Pump-2 Phase 3 Study

Infusion Site Reactions

In the PRONTO-Pump-2 study, the incidence of TEAEs was higher with the Lyumjev treatment group compared with the Humalog 100 units/mL treatment group including

  • 130 patients (60.5%) in the Lyumjev treatment group, and
  • 97 patients (44.7%) in the Humalog 100 treatment group.1

This incidence of TEAEs was primarily driven by an increase in infusion site reaction and infusion site pain (Incidence of Treatment-Emergent Adverse Events in the PRONTO-Pump-2 Study From Randomization to Week 16 Prior to Discontinuation of Investigational Product). The majority of these events (94%) were of mild or moderate severity.1,2

Incidence of Treatment-Emergent Adverse Events in the PRONTO-Pump-2 Study From Randomization to Week 16 Prior to Discontinuation of Investigational Product1

Parametersa

Lyumjev
(n=215)

Humalog 100
(n=217)

Patients with ≥1 TEAE

130 (60.5)

97 (44.7)

Infusion site reaction

41 (19.1)

15 (6.9)

Infusion site pain

34 (15.8)

6 (2.8)

Abbreviations: PRONTO-Pump-2 = a Prospective, Randomized, double-blind cOmparisoN of LY900014 to humalog in adults with Type 1 diabetes using cOntinuous subcutaneous insulin infusion; TEAE = treatment-emergent adverse event.

aData presented as n (%).

In the Lyumjev treatment group, most infusion site reactions started during the first 4 weeks after randomization, were primarily mild in severity (~76%), and lasted a median of 2 to 6 days, depending on the type of reaction.3

The incidence of potential treatment-emergent infusion site reactions using MedDRA search terms were reported by

  • 37.7% of patients in the Lyumjev treatment group, and
  • 10.6% of patients in the Humalog 100 treatment group.2,3

Even if different infusion site reaction events occurred at different infusion site and/or when the infusion set was changed, the resolution of individual infusion site reactions occurred during the study.3

From the patients on Lyumjev treatment and experiencing TEAEs, 7 (3.3%) discontinued investigational product as a result of infusion site reaction, including

  • 6 patients who discontinued investigational product within the first 4 weeks, and
  • 1 patient who discontinued investigational product between weeks 4 and 6 after starting the treatment.1

Subgroup Analyses

Subgroup analyses for the incidence of infusion site reactions showed no significant treatment-by-subgroup interaction when they have been conducted by

  • age
  • BMI
  • bolus speed
  • duration of continuous subcutaneous insulin infusion (CSII)
  • duration of diabetes
  • gender
  • infusion-set model, and
  • total daily dose.1

Subgroup analyses for the incidence of infusion site reactions showed significant interaction for

The incidence of infusion site reactions with cannula length >6 mm was similar between treatment groups; however, a significant higher incidence of infusion site reactions was observed in the Lyumjev treatment group when the cannula length was 6 mm (p<.001, Incidence of Infusion Site Reactions by Cannula Length and by Regions in the PRONTO-Pump-2 Study From Randomization to Week 16 Prior to Discontinuation of Investigational Product).1,3

In the US region, the incidence of infusion site reactions were similar between treatments; however, a significant higher incidence of infusion site reactions was observed in the Lyumjev treatment group in the non-US regions (p<.001, Incidence of Infusion Site Reactions by Cannula Length and by Regions in the PRONTO-Pump-2 Study From Randomization to Week 16 Prior to Discontinuation of Investigational Product).1,3

Incidence of Infusion Site Reactions by Cannula Length and by Regions in the PRONTO-Pump-2 Study From Randomization to Week 16 Prior to Discontinuation of Investigational Product1-3

Parametersa

Lyumjev
(n=215)

Humalog 100
(n=217)

Cannula length

6 mm

23 of 94 (24.5)b

5 of 103 (4.9)

>6 mm

18 of 118 (15.3)c

10 of 113 (8.8)

Regions

US

7 of 87 (8.0)d

6 of 88 (6.8)

Non-US

34 of 128 (26.6)b

9 of 129 (7.0)

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

aData presented number of patients per subgroup (%).

bp<.001 vs IL-100.

cp=.149 vs IL-100.

dp=.765 vs. IL-100.

Study details

The PRONTO-Pump-2 study was a phase 3, prospective, randomized, outpatient, multicenter, 2-treatment group, parallel, active-controlled, double-blind study conducted in patients with type 1 diabetes mellitus (T1DM) currently using CSII therapy.1

Patients were randomized to receive either Lyumjev or Humalog 100 units/mL treatment as both basal and bolus insulin. The bolus doses were administered 0 to 2 minutes prior to meal.1

The study was designed to demonstrate noninferiority of Lyumjev when compared with Humalog 100 in change in HbA1c level from baseline to week 16, when both were used via CSII and bolus doses were given prior to the start of the meal.

The study periods included

  • 1-week screening
  • 2-week lead-in
  • 16-week treatment, and
  • 4-week safety follow-up.1

References

1Warren 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

2Data on file, Eli Lilly and Company and/or one of its subsidiaries.

3Ignaut DA, Cho JI, Elpers JC, et al. Assessing infusion site reactions with URLi in continuous subcutaneous insulin infusion. Diabetes. 2021;70(suppl 1). American Diabetes Association abstract 104-LB. https://doi.org/10.2337/db21-104-LB

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: 14 April 2021


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