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RecruitingPhase 3

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

A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Baricitinib to Preserve Beta Cell Function in Participants Newly Diagnosed With Type 1 Diabetes Aged ≥1 to <36 Years

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
1 Year to 35 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether baricitinib can help protect beta cells, the cells that make insulin. It is for children and adults newly diagnosed with type 1 diabetes. Taking part lasts about 60 weeks.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Were diagnosed with type 1 diabetes within 100 days before starting study treatment.
  • Have at least one diabetes-related autoantibody at screening. These are proteins that can attack the body's own cells.
  • Still make some insulin, shown by a C-peptide blood test result of at least 0.2 nmol/L (0.6 ng/mL) after stimulation at screening.
  • Weigh at least 8 kilograms (18 pounds) at screening.

Who can't join

  • Have another type of diabetes, including diabetes during pregnancy.
  • Have high blood pressure that is not controlled.
  • Have had a heart attack, heart disease, stroke, or heart failure.
  • Have a history of, or high risk for, blood clots in veins, cancer, or a disease that causes too many lymphocytes (a type of white blood cell).
  • Have a current or recent serious medical condition or infection.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (5)

CO

FL

PA

TX

VA