A Study of Baricitinib (LY3009104) to Preserve Beta Cell Function in Children and Adults Newly Diagnosed With Type 1 Diabetes (BARICADE-PRESERVE)

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

  • Diabetes Mellitus, Type 1

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

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