URLi is a novel prandial insulin lispro formulation developed to more closely match physiological insulin secretion. PRONTO-T2D, a Phase 3, double-blind, treat-to-target study in pts with T2D, showed URLi, in a basal-bolus regimen with glargine or degludec, was non-inferior for HbA1c with superior PPG control vs. Humalog. Subgroup analyses were performed in pts <65 vs. ≥65 years. Baseline characteristics were similar except age and duration of T2D (Table 1). With 26 weeks of study treatment, HbA1c improved in both treatment/age groups with endpoint mean HbA1c 6.8-6.9%. URLi significantly reduced 1- and 2-hour PPG excursions with standardized meal tests vs. Humalog in both age groups. Insulin dosing was not significantly different. Severe hypoglycemia incidence was low. While there was no treatment difference in documented hypoglycemia (glucose <54 mg/dL), relative rate (URLi/Humalog) was lower in pts ≥65 vs. < 65 years, with a significant treatment-by-age interaction. Nocturnal hypoglycemia was not significantly different between groups. Incidence of overall treatment-emergent adverse events was similar between treatment/age groups. URLi in a basal-bolus regimen resulted in endpoint HbA1c <7% and significantly lower PPG excursions vs. Humalog in both age groups, with reduced documented hypoglycemia in older vs. younger pts.
A.M. Chang: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. T. Hardy: Other Relationship; Self; Eli Lilly and Company. Q. Zhang: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company.
Eli Lilly and Company