URLi is a novel prandial insulin lispro formulation developed to more closely match physiological insulin secretion and improve PPG control. In PRONTO-T1D, a phase 3, 26-week, treat-to-target study comparing URLi to Humalog in patients with T1D on a multiple daily injection regimen with insulin glargine or degludec, mealtime URLi was non-inferior to mealtime Humalog for change from baseline HbA1c and superior for PPG control, with a similar safety profile to Humalog. Randomization to treatment was stratified by basal insulin type, baseline HbA1c and prandial insulin dosing plan (carb counting, yes/no). The impact of these subgroups and baseline 2-hour PPG on the efficacy and safety of URLi was assessed from the double-blind treatment groups: mealtime URLi (n=451) and mealtime Humalog (n=442). No significant treatment-subgroup interactions were noted (all p>0.1) but occasional treatment differences were seen within each subgroup (p<0.05) (Table 1.). Numerically, results suggest that basal insulin type, starting PPG, and starting HbA1c, but not prandial dosing plan, may influence the magnitude of the HbA1c improvement and/or hypoglycemia risk reduction among patients treated with URLi.
J.M. Bue-Valleskey: Employee; Self; Eli Lilly and Company. J. Cho: None. T. Hardy: Other Relationship; Self; Eli Lilly and Company.
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