Eli Lilly ultra rapid lispro provides similar A1C reductions compared to Humalog
Two phase 3 studies show that Eli Lilly's ultra rapid lispro provided non-inferior A1C reductions compared to Humalog at 26 weeks in people with type 1 and type 2 diabetes. The data from these treat-to-target studies showed URLi also significantly reduced the rise in blood glucose one hour and two hours after a test meal compared to Humalog. Additional data from the study in people with type 1 diabetes demonstrated URLi significantly improved glucose time in range during the day.3 URLi is an investigational novel mealtime insulin formulation being developed to better manage blood glucose levels. These data and several other studies were presented at the American Diabetes Association's 79th Scientific Sessions. The two phase 3 studies, PRONTO-T1D and PRONTO-T2D, evaluated the safety and efficacy of URLi compared to Humalog in adults with type 1 and type 2 diabetes, respectively. Both studies met the primary endpoint of non-inferior A1C reduction from baseline compared to Humalog at 26 weeks, when the insulins were dosed at mealtime. Further, URLi demonstrated superior reduction in blood glucose spikes at both one hour after a test meal compared to Humalog. The PRONTO studies were designed as treat-to-target, which enables clinicians to determine differences in other important treatment effects - such as rates of hypoglycemia, post-meal glucose control and glucose time in range - at the same level of glycemic control. A sub-set of participants in PRONTO-T1D were evaluated using blinded continuous glucose monitoring to provide more complete information on daily blood glucose patterns. At 26 weeks, URLi demonstrated a significantly better blood glucose profile up to four hours after breakfast compared to Humalog. The study further showed that URLi had significantly longer time in range during the day and similar time in range during the night compared to Humalog. Data from a phase 1 clinical pharmacology study in people with type 1 diabetes also demonstrated URLi's effect on post-meal blood glucose control. Results showed URLi was absorbed significantly faster into the blood stream compared to Humalog, insulin aspart and fast-acting insulin aspart. URLi also showed lower blood glucose spikes after a test meal compared to the insulins tested, which was significant compared to Humalog and insulin aspart. Additionally, the early blood glucose profile with URLi closely matched that of participants without diabetes. Lilly submitted applications for URLi with regulatory authorities in Europe and Japan and plans to submit in the U.S. later this year.