A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Baricitinib to Delay Stage 3 Type 1 Diabetes in At-risk Participants Aged ≥1 to <36 Years
Eli Lilly and Company
Summary
The purpose of this study is to find out if baricitinib can delay the onset of clinical type 1 diabetes (T1D) in people who are at high risk to develop T1D. Participation in the study will last up to approximately 5 years.
Eligibility
- Age range
- 1–35 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Have a history of at least one documented occasion of at least two diabetes-related autoantibodies, AND one occasion of at least two diabetes-related autoantibodies obtained at screening or prescreening * Have Stage 1b or Stage 2 type 1 diabetes * Have a body weight of ≥8 kilograms (kg) (18 pounds) at screening Exclusion Criteria: * Have any other type of diabetes * 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 *…
Interventions
- DrugBaricitinib
Administered orally
- DrugPlacebo
Administered orally
Locations (107)
- Tallahassee Memorial HealthCareTallahassee, Florida
- University of South FloridaTampa, Florida
- University of IowaIowa City, Iowa
- Iowa Diabetes and Endocrinology Research CenterWest Des Moines, Iowa
- Novak Center for Children's HealthLouisville, Kentucky
- Children's Hospital of Philadelphia (CHOP)Philadelphia, Pennsylvania