Disclaimer

The elements presented on this page are not an exhaustive list of information relating to the clinical trial. The inclusion and exclusion criteria have been simplified and should be interpreted by a physician. For more information please visit CTIS website for BARICADE-DELAY

Study design 

  • Official Title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Baricitinib to Delay Stage 3 Type 1 Diabetes in At-risk Participants Aged ≥1 to <36 Years
  • Study Type: Interventional Clinical Trial
  • Estimated Enrollment: 150 participants
  • Study Design: Participants will be randomized (2:1) to either baricitinib or placebo
  • 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.
  • Duration of Participation: This period of the study will last for up to 117 weeks or longer and will end when you have been diagnosed with Stage 3 T1D or based on other study related factors.

Criteria

Recruitment for this study is only open to people who meet these criteria.

Highlighted Inclusion:

  • Age 1 to <36 years old (For European Countries: participants must be 2 to <36 years old) 
  • Participants diagnosed with Stage 1b or Stage 2 type 1 diabetes 
  • Have a body weight of ≥8 kilograms (kg) (18 pounds) at screening (For European Countries: participants must have body weight ≥10 kg (22 pounds)) 
  • 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 

Highlighted Exclusion: 

  • Having any other type of diabetes 
  • Having uncontrolled high blood pressure 
  • Having had a heart attack, heart disease, stroke, or heart failure 
  • Having a history or high risk of venous thromboembolism, lymphoproliferative disease or malignancy 
  • Having a current or recent clinically serious infection 

Outcome measures

  • Time from randomization to diagnosis of Stage 3 Type 1 Diabetes 

Locations

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Participating INNODIA Sites
Please note that this list will be updated regularly

This does not mean that all INNODIA Clinical Trial Sites will participate in this specific study.   
Some additional sites that are not part of the INNODIA Network may run this study too.   
A complete list of participating sites can be found on CTIS website.

Sponsors and Collaborators

Eli Lilly Co