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.