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.
Tallahassee Memorial HealthCare
Tallahassee, Florida, United States
NOT_YET_RECRUITINGUniversity of South Florida
Tampa, Florida, United States
NOT_YET_RECRUITINGUniversity of Iowa
Iowa City, Iowa, United States
NOT_YET_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
NOT_YET_RECRUITINGWomen's and Children's Hospital
Adelaide, Australia
RECRUITINGBox Hill Hospital
Box Hill, Australia
RECRUITINGRoyal Brisbane and Women's Hospital
Brisbane, Australia
NOT_YET_RECRUITING...and 97 more locations