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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

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

ArmDescriptionAssigned Intervention
Experimental
Baricitinib 		Participants will receive baricitinib orally
  • Drug: Baricitinib
    Administered orally
    Other names:
    • LY3009104
Placebo Comparator
Placebo 		Participants will receive placebo orally
  • Drug: Placebo
    Administered orally

Recruiting Locations

Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa 50266
Contact:
515-329-6800

University of Virginia
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) or
1-317-615-4559
LillyTrials@Lilly.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.