RECRUITINGPhase 3INTERVENTIONAL
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
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
Baricitinib
Administered orally
DRUG
Placebo
Administered orally
Locations (20)
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States
Tallahassee Memorial HealthCare
Tallahassee, Florida, United States
Children's Hospital of Philadelphia (CHOP)
Philadelphia, Pennsylvania, United States
Driscoll Children's Hospital
Corpus Christi, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Women's and Children's Hospital
Adelaide, Australia
Centre for Children's Health Research
Brisbane, Australia
Austin Health - Repatriation Hospital
Heidelberg West, Australia
Ipswich Hospital
Ipswich, Australia
Royal Children's Hospital
Melbourne, Australia
Southern Adelaide Diabetes & Endocrine Services
Oaklands Park, Australia
The Royal Melbourne Hospital
Parkville, Australia
Perth Children's Hospital
Perth, Australia
Sydney Children's Hospital
Randwick, Australia
The Children's Hospital at Westmead
Westmead, Australia
Université Libre de Bruxelles - Hôpital Erasme
Brussels, Belgium
UZ Brussel
Brussels, Belgium
Cliniques universitaires Saint-Luc
Brussels, Belgium
Antwerp University Hospital
Edegem, Belgium
UZ Gent
Ghent, Belgium