URLi is a novel formulation of insulin lispro developed to better match physiological insulin response to a meal that demonstrates faster absorption and onset of action than HL. This study aimed to evaluate the efficacy and safety of URLi vs. HL in predominantly Chinese adult patients with T2D. It was a Phase 3, randomized, double-blind study, in which patients with T2D randomly received URLi (395 patients) or HL (200 patients) plus glargine or degludec for 26 weeks. The primary endpoint was the treatment difference in the change in HbA1c from baseline to Week 26 (noninferiority margin 0.4%) . The treatment differences in the 1- and 2-hour PPG excursions at Week 26 were assessed as the multiplicity-adjusted endpoints. URLi achieved noninferiority to HL on change in HbA1c with least squares mean difference (95% confidence interval) of 0.07% (-0.07, 0.21) . URLi was superior to HL in controlling 1-hour (4.8 mmol/L vs. 5.6 mmol/L, P <0.001) and 2-hour PPG excursions (6.2 mmol/L vs. 7.4 mmol/L, P <0.001) at Week 26. A greater decrease in daily mean 1- and 2-hour PPG excursions with URLi than HL from baseline to Week 26 was observed in the 10-point self-monitored blood glucose profile. Increase in the dose of bolus insulin from baseline to Week 26 was slightly higher with URLi than HL (0.21 U/kg/day vs. 0.18 U/kg/day, P=0.045) . During the 26-week treatment period, both groups showed similar and low rate and incidence of severe hypoglycemia and documented symptomatic hypoglycemia. The incidences of serious adverse events and treatment-emergent adverse events were comparable between both groups. URLi vs. HL in a basal-bolus regimen demonstrated noninferior glycemic control as assessed by HbA1c and superior control on PPG excursions in predominantly Chinese adult patients with T2D with a similar safety profile.

Disclosure

J. Zhou: n/a. S. Chen: None. J. Cheng: Employee; Eli Lilly and Company. L. Shen: Employee; Eli Lilly and Company. J. Zhu: Employee; Eli Lilly and Company. Y. Lou: None. Y. Bao: None. W. Jia: None.

Funding

Eli Lilly and Company

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