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Looking for participantsPhase3

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

Sponsor: Eli Lilly and Company

NCT ID: NCT07222332

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Baricitinib (drug), Placebo (drug)
How long the study runs
Study runs about 29 months (dates as stated)
About the drug or intervention
Baricitinib — drug: Administered orally · Placebo — drug: Administered orally
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
1 Year to 35 Years
Who
All
Number of participants
300
Started
2026-02-05
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for diabetes mellitus, type 1
  • • Phase3 - 300 participants
  • • The purpose of this study is to find out if baricitinib can preserve beta-cell function in participants newly diagnosed with type 1 diabetes

Who can take part?

  • • Ages 1 Year to 35 Years
  • • Diagnosed with diabetes mellitus, type 1

Where?

  • • Aberdeen - Aberdeen Royal Infirmary
  • • Birmingham - Queen Elizabeth Hospital Birmingham
  • • Birmingham - Birmingham Children's Hospital
  • • Bristol - Southmead Hospital
  • • +4 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

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.

Diabetes Mellitus, Type 1

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

  • • Tell us your age for better matching
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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 1 Year - 35 Years
  • Who can join: All genders

What the study is looking for

  • ✓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

Who cannot take part

  • ✗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 cancer
  • ✗Have a current or recent clinically serious medical condition or infection
See the full 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 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

Where Is This Study? (8 UK sites)

Aberdeen Royal Infirmary

Aberdeen AB25 2ZN, United Kingdom

Recruiting
Site contact (verified)
Sam PhilipPrincipal Investigator

Queen Elizabeth Hospital Birmingham

Birmingham B15 2TH, United Kingdom

Recruiting
Site contact (verified)
parth narendranPrincipal Investigator

Birmingham Children's Hospital

Birmingham B4 6NH, United Kingdom

Recruiting
Site contact (verified)
Renuka DiasPrincipal Investigator

Southmead Hospital

Bristol BS10 5NB, United Kingdom

Recruiting
Site contact (verified)
Georgina RussellPrincipal Investigator

Addenbrooke's Hospital

Cambridge CB2 2QQ, United Kingdom

Recruiting
Site contact (verified)
Loredana MarcovecchioPrincipal Investigator

University Hospital of Wales

Cardiff CF14 4XW, United Kingdom

Recruiting
Site contact (verified)
Maitrayee ChoudhuryPrincipal Investigator

Churchill Hospital

Oxford OX3 7LE, United Kingdom

Recruiting
Site contact (verified)
Katharine OwenPrincipal Investigator

Southampton General Hospital

Southampton SO16 6YD, United Kingdom

Recruiting
Site contact (verified)
Nicola TrevelyanPrincipal Investigator

How to Get in Touch

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

Sponsor contact

CONTACT

317-615-4559 LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

Sponsor contact

CONTACT

clinical_inquiry_hub@lilly.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-10