The purpose of this study is to find out if baricitinib can preserve beta-cell function in participants newly diagnosed with type 1 diabetes. Participation in the study will last about 60 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
300
Administered orally
Administered orally
Change from Baseline in C-peptide Area Under the Curve (AUC)
Time frame: Baseline, Week 52
Change from Baseline in Hemoglobin A1c (HbA1c)
Time frame: Baseline, Week 52
Change from Baseline in Number of Manual Insulin Boluses
Time frame: Baseline, Week 52
Rate of Clinically Significant Hypoglycemic Events
Time frame: Baseline through Week 52
Change from Baseline in Fasting C-Peptide
Time frame: Baseline, Week 52
Change from Baseline in Height
Time frame: Baseline, Week 52
Change from Baseline in Mean Total Daily Insulin Dose
Measured during the two weeks prior to the assessment
Time frame: Baseline, Week 52
Change from Baseline in Short Form 36 Version 2 Health Survey, Acute (SF-36v2)
Time frame: Baseline, Week 52
Change from Baseline in Matsuda Index
Time frame: Baseline, Week 52
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib
Time frame: Predose through Week 16
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.
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States
NOT_YET_RECRUITINGTallahassee Memorial HealthCare
Tallahassee, Florida, United States
NOT_YET_RECRUITINGChildren's Hospital of Philadelphia (CHOP)
Philadelphia, Pennsylvania, United States
NOT_YET_RECRUITINGDriscoll Children's Hospital
Corpus Christi, Texas, United States
NOT_YET_RECRUITINGUniversity of Virginia
Charlottesville, Virginia, United States
NOT_YET_RECRUITINGWomen's and Children's Hospital
Adelaide, Australia
RECRUITINGCentre for Children's Health Research
Brisbane, Australia
NOT_YET_RECRUITINGAustin Health - Repatriation Hospital
Heidelberg West, Australia
RECRUITINGIpswich Hospital
Ipswich, Australia
NOT_YET_RECRUITINGRoyal Children's Hospital
Melbourne, Australia
NOT_YET_RECRUITING...and 122 more locations