Full Press Release Details
INDIANAPOLIS , Oct. 2, 2018 /PRNewswire/ -- Readouts from two phase 3 clinical trials demonstrated that Eli Lilly and Company's (NYSE: LLY ) 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.
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HI CON ISI 06JUN2017
About Diabetes Approximately 30 million Americans 1 and an estimated 425 million adults worldwide have diabetes. 2 Type 2 diabetes is the most common type internationally, accounting for an estimated 90 to 95 percent of all diabetes cases in the United States alone. 1 Diabetes is a chronic disease that occurs when the body does not properly produce or use the hormone insulin.
About Eli Lilly and Company Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and www.lilly.com/newsroom/social-channels . P-LLY
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Ultra Rapid Lispro as a treatment of type 1 and type 2 diabetes, and Lilly's current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that future study results will be consistent with study findings to date, that Ultra Rapid Lispro will receive regulatory approvals or that Ultra Rapid Lispro will prove to be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.
| Refer to: | DeShong Perry-Smitherman; [email protected] ; 317-719-4612 (media) |
| Greg Kueterman; [email protected] ; 317-432-5195 (media) | |
| Kevin Hern; [email protected] ; 317-277-1838 (investors) |
SOURCE Eli Lilly and Company