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

Recruiting Phase 3 Interventional Study
Diabetes Mellitus, Type 1
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
1 – 35
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
300 (estimated)
Sponsor
Eli Lilly and Company · Industry
Who this trial is looking for

This trial is looking for children and adults who have recently been diagnosed with type 1 diabetes, specifically within the last 100 days. To join, they need to still show some signs of their pancreas working. However, people with other types of diabetes, serious heart problems, or certain health risks can’t participate.

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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.

Trial Locations
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Eligibility Criteria
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 …
Contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

317-615-4559

LillyTrials@Lilly.com

CONTACT

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

CONTACT