Readouts from two phase 3 clinical trials demonstrated that Eli Lilly and Company’s Ultra Rapid Lispro (URLi) met the primary efficacy endpoint of non-inferior A1C reduction from baseline compared to Humalog (insulin lispro) 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.
“Despite progress in insulin and diabetes management, many people with diabetes find controlling high blood sugar levels after meals frustrating. If approved, URLi will be a new option in mealtime insulin therapy designed to help keep blood sugar in range after eating,” said Thomas Hardy, senior medical director, Insulins Product Development, Lilly Diabetes. “We are encouraged by these data showing that URLi was non-inferior to Humalog in controlling A1C, an overall measure of glucose control, while significantly lowering blood glucose levels during a meal test.”
In both studies, URLi showed overall safety and tolerability similar to Humalog. Lilly plans to present detailed results from these studies in 2019. Based on these results, Lilly will submit URLi to regulatory authorities in 2019.
About the Pronto Studies
Pronto-T1D and Pronto-T2D were randomized, double-blind, controlled, treat-to-target comparisons of ultra rapid lispro (URLi) and Humalog (insulin lispro), both in combination with either insulin glargine or insulin degludec in adults with type 1 and type 2 diabetes, respectively. The primary objective of each study, conducted in 1,222 and 673 participants, respectively, was to evaluate whether URLi is non-inferior to Humalog in reducing A1C from baseline after 26 weeks of treatment. Comparisons of one and two hour post-prandial glucose and A1C superiority were included in the statistical plan. Those comparisons were performed after the primary endpoint of non-inferiority was achieved.
(Source: Eli Lilly and Company)
Filed Under: Drug Discovery