Glycemic Control with Ultra Rapid Lispro (URLi) vs Lispro in Children and Adolescents with Type 1 Diabetes(T1D): PRONTO-Peds

Question Does URLi achieve glycemic control and lower postprandial glucose (PPG) in pediatric patients (pts) with T1D?

Methodology After 4-week lead-in to optimize basal insulin, 716 pts were randomized to double-blind URLi (n=280)/lispro (n=298) injected 0–2 min before meals/open-label URLi (n=138) injected up to 20 min after meals (URLi+20). Pts remained on prestudy basal insulin (degludec/detemir/glargine).

Results Noninferiority was shown in HbA1c change with URLi vs lispro: 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). Postprandial glucose (PPG) measured by self-monitored blood glucose was lower with URLi vs lispro 1h after breakfast (p<0.001) and dinner (p=0.006). URLi significantly reduced 1h postmeal-glucose daily mean vs lispro (p=0.001). There were no significant group differences in rate or incidence of severe/nocturnal/documented hypoglycemia (< 54mg/dL). With URLi vs lispro, rate of postdose hypoglycemia (< 54mg/dL) was higher at ≤ 2h (p=0.034). Incidence of treatment-emergent adverse events (TEAEs) was similar between groups. More pts reported an injection site reaction (ISR) related event with URLi (7.9%) and URLi+20 (2.9%) vs lispro (2.7%). All ISRs were mild or moderate in severity.

Conclusion URLi demonstrated similar overall glycemic control and greater PPG lowering with an acceptable safety and tolerability profile vs lispro. URLi (at start of /up to 20min after meals) showed noninferiority for HbA1c change from baseline vs lispro; URLi dosed at the beginning of meals showed lower PPG at 1h after breakfast and dinner and lower 1h postmeal-glucose daily mean vs lispro.

 

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Interessenkonflikt

This study was funded by Eli Lilly and Company. Previously presented at Association of Diabetes Care & Education Specialists – 2022 Annual Conference; Baltimore, MD; August 12-15, 2022. Authors' conflict of interest information: R. Paul Wadwa received research support, paid to University of Colorado, from Dexcom, Eli Lilly and Company and Tandem Diabetes Care. He has received travel support from Eli Lilly and Company and Dexcom. He has received speaker honorarium from Dexcom. Lori M. Laffel has received research support from Eli Lilly and Company that was granted to her academic institution and has served as a consultant to Eli Lilly and Company. Denise R. Franco is part of advisory boards for Eli Lilly and Company, Novo Nordisk, Medtronic, Sanofi, Abbott, and Biomm. She receives fees to give lectures by Novo Nordisk, Eli Lilly and Company, Novartis, AstraZeneca, Medtronic, Biomm, Sanofi, Abbott, and Roche She has received grants for research from Eli Lilly and Company, Novo Nordisk, Sanofi, and AstraZeneca. Mary Anne Dellva and Robyn K. Pollom are employees and shareholders of Eli Lilly and Company.

Publication History

Article published online:
02 May 2023