Assessing Infusion Site Reactions with Ultra Rapid Lispro (URLi) in Continuous Subcutaneous Insulin Infusion

Background In phase-3 trials, URLi showed superior postprandial glucose control and non-inferior HbA1c reduction versus Lispro. Infusion site reactions (ISRs) were more frequent with URLi.

Methods We analyzed data from the 16-week PRONTO-Pump-2 trial in T1D patients (URLi, N=215; Lispro, N=217).

Results The most frequently reported adverse events (AEs) were infusion site reaction (URLi, n=41[19.1%]; Lispro, n=15[6.9%]) and infusion site pain (URLi, n=34[15.8%]; Lispro, n=6[2.8%]). ISRs were reported by 37.7% of patients on URLi and 10.1% on Lispro. Most ISRs with URLi started in the first 4-weeks after randomization were primarily mild in severity (~76%) and lasted a median of 2-6 days. Overall, 7 (3.3%) patients discontinued URLi treatment due to ISRs.

Gender, age, BMI, ethnicity, race, infusion set model, bolus speed, total daily dose, duration of diabetes and duration of insulin pump use did not impact incidence of ISRs between treatments. Significant treatment-by-subgroup interactions were observed for cannula length (6mm vs > 6mm; p=0.070) and region (US vs non-US; p=0.046): incidence of ISRs with cannula length > 6mm and incidence of ISRs in US was similar between treatments, but a higher incidence of ISRs was observed with URLi when cannula length was 6 mm or in non-US regions.

Conclusions Infusion site reaction and infusion site pain were the most frequently reported AEs. Most were mild and resolved in less than a week. Differential treatment effects on ISR occurrence were seen with cannula length and region. Further studies are needed to confirm these findings.

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Artikel online veröffentlicht:
26. Mai 2022