Diabetes Mellitus, Type 1
Conditions
Keywords
T1DM, Children, New-onset, Beta-cell Function
Brief summary
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.
Interventions
DRUGBaricitinib
Administered orally
DRUGPlacebo
Administered orally
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Have a new diagnosis of type 1 diabetes within 100 days prior to starting study intervention * Have at least one diabetes-related autoantibody found at screening * Show signs of remaining beta-cell function * stimulated (peak or 90 min) C-peptide ≥0.2 nmol/L (0.6 ng/mL) at screening * Weigh at least 8 kilograms (kg) (18 pounds) at screening
Exclusion criteria
* Have any other type of diabetes including gestational * 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 * Have a current or recent clinically serious medical condition or infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in C-peptide Area Under the Curve (AUC) | Baseline, Week 52 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Hemoglobin A1c (HbA1c) | Baseline, Week 52 | — |
| Change from Baseline in Number of Manual Insulin Boluses | Baseline, Week 52 | — |
| Rate of Clinically Significant Hypoglycemic Events | Baseline through Week 52 | — |
| Change from Baseline in Fasting C-Peptide | Baseline, Week 52 | — |
| Change from Baseline in Height | Baseline, Week 52 | — |
| Change from Baseline in Mean Total Daily Insulin Dose | Baseline, Week 52 | Measured during the two weeks prior to the assessment |
| Change from Baseline in Short Form 36 Version 2 Health Survey, Acute (SF-36v2) | Baseline, Week 52 | — |
| Change from Baseline in Matsuda Index | Baseline, Week 52 | — |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib | Predose through Week 16 | — |
Countries
Australia, Belgium, Brazil, Canada, Czechia, Finland, France, Germany, Israel, Italy, Japan, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Ukraine, United Kingdom, United States
Contacts
CONTACTTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACTPhysicians interested in becoming principal investigators please contact
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed