Baricitinib for Beta Cell Preservation in Newly Diagnosed Type 1 Diabetes
Baricitinib
+ Placebo
Autoimmune Diseases+5
+ Diabetes Mellitus
+ Diabetes Mellitus, Type 1
Treatment Study
Summary
Study start date: March 1, 2026
Actual date on which the first participant was enrolled.This study aims to determine if a medication called baricitinib can help maintain the function of beta cells in people who have recently been diagnosed with type 1 diabetes. Beta cells are responsible for producing insulin, which is crucial for managing blood sugar levels. The study focuses on individuals aged 1 to 35 years who have just been diagnosed with type 1 diabetes. By potentially preserving beta cell function, the study hopes to improve long-term health outcomes and manage diabetes more effectively for these patients. Participants in the study will receive either baricitinib or a placebo over a period of about 60 weeks. The treatment is given in a double-blind manner, meaning neither the participants nor the researchers know who is receiving the actual medication and who is getting the placebo. This approach helps ensure the results are unbiased. The main focus is to observe changes in beta cell function, which may influence how well the body can regulate blood sugar levels. As with any medical study, there may be risks and benefits associated with the treatment, which will be closely monitored by the research team.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.300 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 1 to 35 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 128 locations
Barbara Davis Center for Childhood Diabetes
Aurora, United StatesOpen Barbara Davis Center for Childhood Diabetes in Google MapsChildren's Hospital of Philadelphia (CHOP)
Philadelphia, United StatesDriscoll Children's Hospital
Corpus Christi, United StatesUniversity of Virginia
Charlottesville, United States