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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Baricitinib
DrugAdministered orally
Placebo
DrugAdministered orally
Treatment groups
Trial outcomes
Primary outcomes
Time from Baseline to Diagnosis of Stage 3 Type 1 Diabetes
Secondary outcomes
Change from Baseline in Glucose-Stimulated C-peptide Area Under the Curve (AUC)
Change from Baseline in Glucose AUC
Change from Baseline in AUC Ratio (AUC C-peptide/AUC Glucose × 1000)
Change from Baseline in Height
Sponsors and contacts
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