Lyumjev ® ▼ (insulin lispro)

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What are the compatibility and safety data in the Lyumjev®▼ (insulin lispro) PRONTO-Pump study?

In the PRONTO-Pump study, there was no significant difference in the rate of infusion set failures between the Lyumjev and Humalog treatment groups.

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UK_cFAQ_URI059_PHASE_3_PUMP_COMPATIBILITY_SAFETY_DATA
en-GB

PRONTO-Pump Study

PRONTO-Pump was a phase 3, prospective, randomized, double-blind, crossover, active-controlled, outpatient, multinational study that compared Lyumjev (insulin lispro) 100 units/mL with Humalog (insulin lispro) 100 units/mL, both administered via continuous subcutaneous insulin infusion with Dexcom G5® Mobile Continuous Glucose Monitoring System, in adults with type 1 diabetes (T1D).1

The phase 3 pump study was designed to compare Lyumjev with Humalog with respect to the rate of infusion set failures in events/patient/30 days that led to

  • premature infusion set changes due to a pump occlusion alarm, or
  • unexplained hyperglycemia with blood glucose (BG) >13.9 mmol/L (>250 mg/dL) that did not decrease within 1 hour following a correction bolus delivered via pump.1

Compatibility and Safety Results

The rate of infusion set failures met the primary endpoint and was similar for Lyumjev and Humalog.2 

Five events of infusion set failures in 5 patients met the primary endpoint, all due to pump occlusion alarm.2 

The rate of infusion set failure was

  • 0.05 events/patient/30 days with Humalog treatment group, and
  • 0.04 events/patient/30 days with Lyumjev treatment group.2

The infusion set failures occurred on day 1 of infusion set wear in the Lyumjev treatment group and on day 2 of infusion set wear in the Humalog treatment group.1,2

Additional Information on the Study

Unexplained hyperglycemia was defined as a high BG concentration that could not be explained by

  • a missed prior bolus
  • dietary indiscretion
  • rebound or treatment of hypoglycemia
  • a pump failure
  • an empty pump reservoir
  • an infusion set complication such as kinked, came out, or leaking, or
  • an infusion site complication such as pain or redness.2

References

1Bode 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

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

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: 13 October 2022


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