Testing baricitinib to protect insulin-making cells in new type 1 diabetes
Tests baricitinib against placebo in people newly diagnosed with type 1 diabetes.
Plain-language title generated from the registry record
Registry title: A Study of Baricitinib (LY3009104) to Preserve Beta Cell Function in Children and Adults Newly Diagnosed With Type 1 Diabetes (BARICADE-PRESERVE)
Key facts
- Where
- Ancona, Florence, Messina, Milan, Naples, Novara, Padova, and Verona, ItalySee the 9 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 1 and 35 years old?
Source: NCT07222332, who can take part
Where in Italy
- Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G SalesiAncona, ItalyNo longer taking part
- Azienda Ospedaliera Universitaria Meyer IRCCSFlorence, ItalyNo longer taking part
- Azienda Ospedaliero-Universitaria CareggiFlorence, ItalyNo longer taking part
- Università degli Studi di MessinaMessina, ItalyNo longer taking part
- Ospedale San Raffaele S.r.l.Milan, ItalyNo longer taking part
- Azienda Ospedaliera Universitaria Federico II Di NapoliNaples, ItalyNo longer taking part
- Azienda Ospedaliero Universitaria Maggiore della CaritàNovara, ItalyNo longer taking part
- Azienda Ospedaliera di PadovaPadova, ItalyNo longer taking part
- Azienda Ospedaliera Universitaria Integrata VeronaVerona, ItalyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Eli Lilly and Company
- Trial code
- NCT07222332EU 2025-522170-36-00
- Record updated
- 4 November 2026
- Original description
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.Read full original descriptionShow less
A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Baricitinib to Preserve Beta Cell Function in Participants Newly Diagnosed With Type 1 Diabetes Aged ≥1 to <36 Years
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.
Inclusion: 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: Have any other type of diabetes including gestational; 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; Have uncontrolled high blood pressure.