Health Trials

A Study of Baricitinib (LY3009104) to Preserve Beta Cell Function in Children and Adults Newly Diagnosed With Type 1 Diabetes (BARICADE-PRESERVE)

ConditionDiabetes Mellitus, Type 1
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age1-35
SponsorEli Lilly and Company

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Baricitinib

    Drug

    Administered orally

  • Placebo

    Drug

    Administered orally

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: BaricitinibExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from Baseline in C-peptide Area Under the Curve (AUC)

Time frame
Baseline, Week 52

Secondary outcomes

1

Change from Baseline in Hemoglobin A1c (HbA1c)

Time frame
Baseline, Week 52
2

Change from Baseline in Number of Manual Insulin Boluses

Time frame
Baseline, Week 52
3

Rate of Clinically Significant Hypoglycemic Events

Time frame
Baseline through Week 52
4

Change from Baseline in Fasting C-Peptide

Time frame
Baseline, Week 52

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eli Lilly and Company

Lead sponsor

Source ClinicalTrials.gov
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