URLi is a novel formulation of insulin lispro developed to better mimic the physiological glucose response postmeal. This analysis was to evaluate URLi vs. lispro in Chinese subpopulation from a phase 3 global study (PRONTO-Peds) in pediatric patients with T1D. Chinese patients were randomized to double-blind mealtime URLi (n=7) , lispro (n=11) , or open-label URLi dosed up to 20 minutes postmeal (URLi+20; n=4) . The primary endpoint was the difference between URLi and lispro in HbA1c change from baseline to Week 26, with the difference between URLi+20 and lispro in HbA1c change being also assessed. The mixed-effect model repeated measure model was used for analyzing the primary endpoint. Same trend in the treatment difference in HbA1c change from baseline to Week 26 was observed in Chinese patients as the overall population (URLi minus lispro: -0.09% vs. -0.02%; URLi+20 minus lispro: -0.31% vs. -0.02%) , with HbA1c increases in URLi, lispro, and URLi+20 groups by 1.06%, 1.15%, and 0.85%, respectively. In Chinese patients, the premeal to 1-hour postmeal daily mean glucose excursion was numerically lower with URLi (-31.1 mg/dL) than with lispro (15.3 mg/dL) or with URLi+20 (39.2 mg/dL) at Week 26. No clinically meaningful treatment differences were observed at baseline and Week 26 for basal, bolus, and total insulin dose. No death, serious adverse events including severe hypoglycemia, discontinuations due to adverse events, and treatment-emergent injection site reactions occurred. At Weeks 0 to 26, the rate of all documented hypoglycemia and documented hypoglycemia at ≤4 h and >4 h postdose for blood glucose ≤70 mg/dL showed numerically greater decrease from baseline with URLi and URLi+20 than with lispro. Overall, mealtime and postmeal URLi vs. lispro demonstrated same trend in the glycemic control as assessed by HbA1c in Chinese pediatric patients with T1D as the overall population and a similar safety profile.
W.Gu: None. Y.Yang: Employee; Eli Lilly and Company. Y.Yuan: None. F.Luo: None.
Eli Lilly and Company
