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RECRUITINGPhase 3INTERVENTIONAL

A Study of Baricitinib (LY3009104) for the Delay of Stage 3 Type 1 Diabetes in At-Risk Children and Adults

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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. Participation in the study will last up to approximately 5 years.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 - Have Stage 1b or Stage 2 type 1 diabetes - Have a body weight of ≥8 kilograms (kg) (18 pounds) at screening Who Should NOT Join This Trial: - Have any other type of diabetes - 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 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 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 * Have Stage 1b or Stage 2 type 1 diabetes * Have a body weight of ≥8 kilograms (kg) (18 pounds) at screening Exclusion Criteria: * Have any other type of diabetes * 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 infection

Treatments Being Tested

DRUG

Baricitinib

Administered orally

DRUG

Placebo

Administered orally

Locations (20)

Tallahassee Memorial HealthCare
Tallahassee, Florida, United States
University of South Florida
Tampa, Florida, United States
University of Iowa
Iowa City, Iowa, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, United States
Novak Center for Children's Health
Louisville, Kentucky, United States
Children's Hospital of Philadelphia (CHOP)
Philadelphia, Pennsylvania, United States
University of Virginia
Charlottesville, Virginia, United States
Women's and Children's Hospital
Adelaide, Australia
Box Hill Hospital
Box Hill, Australia
Royal Brisbane and Women's Hospital
Brisbane, Australia
Centre for Children's Health Research
Brisbane, Australia
Royal Children's Hospital
Melbourne, 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
UZ Brussel
Brussels, Belgium
Cliniques universitaires Saint-Luc
Brussels, Belgium
Antwerp University Hospital
Edegem, Belgium
UZ Leuven
Leuven, Belgium