A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Baricitinib to Preserve Beta Cell Function in Participants Newly Diagnosed With Type 1 Diabetes Aged 1 to 36 Years

What this Trial Is About

Researchers are evaluating whether baricitinib can help preserve beta-cell function in children and adults newly diagnosed with type 1 diabetes. This Phase 3 study focuses on participants aged 1 to less than 36 years and aims to understand how baricitinib affects the progression of the disease by comparing it to a placebo. The study is led by Eli Lilly and Company and will last about 60 weeks. Participants are randomly assigned to receive either baricitinib or a placebo, both administered orally. The study is double-blind, meaning neither participants nor researchers know who receives which treatment during the trial. The main treatment period will last up to 52 weeks, during which various health measures related to diabetes control and beta-cell function will be monitored. During the study, participants will undergo regular assessments including measurements of C-peptide levels, hemoglobin A1c, insulin doses, and hypoglycemic events. Researchers will also evaluate physical growth, health survey responses, and pharmacokinetics of baricitinib. Safety monitoring and follow-up visits will continue throughout the approximately 60-week participation period to gather comprehensive data on the impact of the treatment.

A Study of Baricitinib (LY3009104) to Preserve Beta Cell Function in Children and Adults Newly Diagnosed With Type 1 Diabetes (BARICADE-PRESERVE)