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Recruiting
NCT07222332
A Study of Baricitinib (LY3009104) to Preserve Beta Cell Function in Children and Adults Newly Diagnosed With Type 1 Diabetes (BARICADE-PRESERVE)
Conditions: Diabetes Mellitus, Type 1
Sex: All
Ages: 1 Year – 35 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 300
Sponsor: Eli Lilly and Company
Location: Barbara Davis Center for Childhood Diabetes Aurora Colorado
Summary
The purpose of this study is to find out if baricitinib can preserve beta-cell function in participants newly diagnosed with type 1 diabetes. Participation in the study will last about 60 weeks.
Eligibility Criteria
Inclusion Criteria:
* Have a new diagnosis of type 1 diabetes within 100 days prior to starting study intervention
* Have at least one diabetes-related autoantibody found at screening
* Show signs of remaining beta-cell function
* stimulated (peak or 90 min) C-peptide ≥0.2 nmol/L (0.6 ng/mL) at screening
* Weigh at least 8 kilograms (kg) (18 pounds) at screening
Exclusion Criteria:
* Have any other type of diabetes including gestational
* Have uncontrolled high blood pressure
* Have had a heart attack, heart disease, stroke, or heart failure
* Have a history or high risk of venous thromboembolism, lymphoproliferative disease or malignancy
* Have a current or recent clinically serious medical condition or infection
Source: ClinicalTrials.gov (NCT07222332). StuddyBuddy aggregates publicly available trial information.