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ORLANDO, Fla. — Eli Lilly’s ultra rapid lispro (URLi) led to improved and sustained blood sugar control after meals in people with type 1 and type 2 diabetes, according to results from three phase 1b studies evaluating URLi compared to Humalog. URLi is Lilly’s novel mealtime insulin currently in phase 3 development. The data was presented in three poster presentations at the American Diabetes Association (ADA) 78th Scientific Sessions last weekend here.
Two of the studies evaluated URLi administered through multiple daily injections in people with type 1 and type 2 diabetes to understand the differences in the pharmacokinetics (the amount of insulin in the blood) and pharmacodynamics (how insulin works to control blood glucose levels) between URLi and Humalog. The third study evaluated URLi delivered through an insulin pump in people with type 1 diabetes. Across all three studies, URLi was absorbed faster than Humalog, which led to improved post-meal blood sugar control that was sustained over time.
Researchers used solid mixed meal tolerance tests (MMTT) to evaluate URLi in people with type 1 and type 2 diabetes, measuring post-meal blood sugar response based on injections 15 minutes before a meal, at the start of the meal, or 15 minutes after the start of a meal. Results showed that compared to Humalog, URLi reduced post-meal blood sugar over the first five hours after eating by 44% in people with type 1 diabetes and 105% in people with type 2 diabetes when dosed at mealtime. URLi was also evaluated in people with type 1 diabetes using insulin pumps. Results of MMTTs conducted on days 1 and 3 of pump treatment showed that URLi reduced post-meal blood sugar by 20 to 57% over the five-hour period after eating.
Overall, URLi and Humalog had similar safety and tolerability profiles across all three studies.
“This data bolsters our confidence in ultra rapid lispro as the next advancement for people who require mealtime insulin,” said Tom Hardy, senior medical director at Lilly. “Managing diabetes with mealtime insulin can be difficult, often requiring a strict schedule around what and how much people eat, as well as when they take their insulin. URLi has the potential to improve mealtime blood sugar control for people with type 1 and type 2 diabetes.”
URLi is currently in phase 3 studies in people with type 1 and type 2 diabetes. These trials are expected to complete later this year.
