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

NCT07222332

RecruitingPhase 3

Sponsor: Eli Lilly and Company

Conditions: Diabetes Mellitus, Type 1

Interventions: Baricitinib, Placebo

Countries: United States, Australia, Belgium, Brazil, Canada, Czechia, Finland, France

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 overview

Sex: ALL

Age: 1 Year to 35 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (138)
  • Aurora, Colorado, United States
  • Tallahassee, Florida, United States
  • Philadelphia, Pennsylvania, United States
  • Corpus Christi, Texas, United States
  • Charlottesville, Virginia, United States
  • Adelaide, Australia
  • Brisbane, Australia
  • Heidelberg West, Australia
  • Ipswich, Australia
  • Melbourne, Australia
  • Oaklands Park, Australia
  • Parkville, Australia
  • Perth, Australia
  • Randwick, Australia
  • Westmead, Australia
  • Brussels, Belgium
  • Brussels, Belgium
  • Brussels, Belgium
  • Edegem, Belgium
  • Ghent, Belgium
  • Leuven, Belgium
  • Liège, Belgium
  • Namur, Belgium
  • Yvoir, Belgium
  • Campo Grande, Brazil
  • Curitiba, Brazil
  • Curitiba, Brazil
  • Fortaleza, Brazil
  • Goiânia, Brazil
  • Marília, Brazil
  • + 108 more on CT.gov