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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 1 Year and 35 Years
Eligible Sex
All
Accepts 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 thromboembolism, lymphoproliferative disease or malignancy - Have a current or recent clinically serious medical condition or 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

Barbara Davis Center for Childhood Diabetes
Aurora, Colorado 80045
Contact:
303-724-3861

Tallahassee Memorial HealthCare
Tallahassee, Florida 32308
Contact:
850-431-5404

Driscoll Children's Hospital
Corpus Christi, Texas 78411
Contact:
361-739-7250

University of Virginia
Charlottesville, Virginia 22903
Contact:
434-422-2653

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
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.