A Study of Baricitinib (LY3009104) for the Delay of Stage 3 Type 1 Diabetes in At-Risk Children and Adults
Purpose
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.
Condition
- Diabetes Mellitus, Type 1
Eligibility
- Eligible Ages
- Between 1 Year and 35 Years
- Eligible Sex
- All
- Accepts 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 - Have a current or recent clinically serious infection
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Baricitinib |
Participants will receive baricitinib orally |
|
|
Placebo Comparator Placebo |
Participants will receive placebo orally |
|
Recruiting Locations
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa 50266
West Des Moines, Iowa 50266
Contact:
515-329-6800
515-329-6800
University of Virginia
Charlottesville, Virginia 22903
Charlottesville, Virginia 22903
More Details
- Status
- Recruiting
- Sponsor
- Eli Lilly and Company
Study Contact
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or1-317-615-4559
LillyTrials@Lilly.com