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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age1-35
SponsorEli Lilly and Company

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Baricitinib
  • Placebo

Treatment groups

300 Participants
are divided into 2 treatment groups

Sponsors and collaborators