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# Lilly Plans 2019 NDA for Diabetes Therapy URLi
- URL: https://www.fdaweb.com/lilly-plans-2019-nda-for-diabetes-therapy-urli/
- Published: 2018-10-02T12:00:00.000Z
- Updated: 2026-09-15T00:35:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142491

Eli Lilly plans to submit an NDA for Ultra Rapid Lispro (URLi) in 2019 after reporting favorable clinical trial data from two Phase 3 trials that it says 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 Type 1 and Type 2 diabetes patients. 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, “demonstrated superior reduction in glucose excursions at both one and two hours during a meal test,” Lilly says. “The studies showed no significant difference in severe, nocturnal or overall hypoglycemia rates reported by study participants.”