A Study of Baricitinib (LY3009104) for the Delay of Stage 3 Type 1 Diabetes in At-Risk Children and Adults
Phase 3 – large-scale trial before approval
Conditions:
Diabetes Mellitus, Type 1
Sponsor: Eli Lilly and Company
trial.available_in:
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Overview
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 can participate
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