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
Eli Lilly and Company
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
- Age range
- 1–35 years
- Sex
- All
- Healthy volunteers
- No
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 thromb…
Interventions
- DrugBaricitinib
Administered orally
- DrugPlacebo
Administered orally
Locations (132)
- Barbara Davis Center for Childhood DiabetesAurora, Colorado
- Tallahassee Memorial HealthCareTallahassee, Florida
- Children's Hospital of Philadelphia (CHOP)Philadelphia, Pennsylvania
- Driscoll Children's HospitalCorpus Christi, Texas
- University of VirginiaCharlottesville, Virginia
- Women's and Children's HospitalAdelaide