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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
150
Administered orally
Administered orally
Time from Baseline to Diagnosis of Stage 3 Type 1 Diabetes
Time frame: Baseline up to approximately 5 years
Change from Baseline in Glucose-Stimulated C-peptide Area Under the Curve (AUC)
Time frame: Baseline, Week 52
Change from Baseline in Glucose AUC
Time frame: Baseline, Week 52
Change from Baseline in AUC Ratio (AUC C-peptide/AUC Glucose × 1000)
Time frame: Baseline, Week 52
Change from Baseline in Height
Time frame: Baseline, Week 52
Change from Baseline in Body Mass Index (BMI) Percentile
Time frame: Baseline, Week 52
Change in Glucose Time in Range Between 70 and 180 mg/dL (inclusive)
Time frame: Baseline, Week 52
Change from Baseline in Short Form 36 Version 2 Health Survey, Acute (SF-36v2)
Time frame: Baseline, Week 52
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib
Time frame: Predose through Week 24
PK: Area Under the Concentration Versus Time Curve (AUC) of Baricitinib
Time frame: Predose through Week 24
Change from Baseline in Matsuda Index
Time frame: Baseline, Week 52
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Sansum Diabetes Research Institute
Santa Barbara, California, United States
NOT_YET_RECRUITINGTallahassee Memorial HealthCare
Tallahassee, Florida, United States
RECRUITINGUniversity of South Florida
Tampa, Florida, United States
SUSPENDEDUniversity of Iowa
Iowa City, Iowa, United States
RECRUITINGIowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, United States
RECRUITINGNovak Center for Children's Health
Louisville, Kentucky, United States
NOT_YET_RECRUITINGChildren's Hospital of Philadelphia (CHOP)
Philadelphia, Pennsylvania, United States
NOT_YET_RECRUITINGUniversity of Virginia
Charlottesville, Virginia, United States
RECRUITINGWomen's and Children's Hospital
Adelaide, Australia
RECRUITINGBox Hill Hospital
Box Hill, Australia
RECRUITING...and 103 more locations