Eli Lilly's PRONTO-T1D, PRONTO-T2D meet primary efficacy endpoint
Readouts from two phase 3 clinical trials demonstrated that Eli Lilly's Ultra Rapid Lispro, or URLi, met the primary efficacy endpoint of non-inferior A1C reduction from baseline compared to Humalog and also demonstrated significantly improved post-meal glucose control in people with type 1 and type 2 diabetes. URLi is Lilly's novel mealtime insulin formulation that was developed to help better control blood glucose levels after meals by more closely mirroring the way insulin works in people without diabetes. The two phase 3 studies, PRONTO-T1D and PRONTO-T2D, evaluated the safety and efficacy of URLi compared to Humalog in people with type 1 and type 2 diabetes, respectively. The primary efficacy endpoint of non-inferiority to Humalog, as measured by A1C reduction from baseline, was met in both studies at 26 weeks. In both populations, URLi demonstrated superior reduction in glucose excursions at both one and two hours during a meal test. The studies showed no significant difference in severe, nocturnal or overall hypoglycemia rates reported by study participants.