EASD 2022: Glycaemic Control with Ultra Rapid Lispro (URLi) Vs Lispro in Children and Adolescents with Type 1 Diabetes: PRONTO-PEDS
The abstract demonstrates the results of a phase 3, treat-to-target study examining the efficacy and safety of URLi vs lispro in paediatric patients (pts) with type 1 diabetes (T1D).
In this analysis, the children were randomized to double-blind URLi (n=280) or lispro (n=298) injected 0-2 min prior to meals, or open-label URLi (n=138) injected up to 20 min after meals (URLi+20) post a 4-week lead-in to optimize basal insulin. The patients were continued on pre-study basal insulin. A change in HbA1c at 26 weeks from baseline was observed as the primary endpoint.
The study results demonstrated that URLi is non-inferior to insulin lispro with respect to HbA1c reduction [estimated treatment difference (ETD) -0.02% (95% CI -0.17, 0.13) and with URLi+20 vs lispro: ETD -0.02% (95% CI -0.20, 0.17)]. As measured by self-monitored blood glucose (SMBG), URLi group had lower postprandial glucose as compared to insulin lispro, 1 hour after breakfast (p<0.001) and dinner (p=0.006; URLi also significantly lowered the daily mean 1 hour post meal glucose as compared to lispro (p=0.001). The total insulin dose and treatment emergent adverse events was similar in both treatments. The rate of incidence of severe, nocturnal or documented hypoglycaemia (<3.00 mmol/L [<54 mg/dL]) showed no significant difference between the two groups. More patients reported an injection site reaction related event with URLi (7.9%) and URLi+20 (2.9%) vs lispro (2.7%). All injection site reactions were mild or moderate in severity. Two URLi patients discontinued the study due to injection site reactions.
This study elucidates that URLi offers similar overall glycaemic control and when dosed at beginning of meals, there was greater PPG lowering than insulin lispro in children and adolescents with type 1 diabetes. It also demonstrates a favourable safety and tolerability profile among these individuals.
Abstract 688 European Association for the Study of Diabetes (EASD) International Congress 2022, 19th – 23rd Sept. 2022, Stockholm
