Recruiting at 108 sites Phase 3 Diabetes Mellitus, Type 1

Diabetes Mellitus, Type 1 study: Baricitinib

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

ClinicalTrials.gov ID: NCT07222332

What this study is testing

What is Baricitinib?

This is an investigational oral medicine being studied to see if it can help preserve beta-cell function in people newly diagnosed with type 1 diabetes. It is designed to block specific enzymes in the body that are involved in immune system signaling.

Also referred to as LY3009104.

Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
The study aims to see if baricitinib can preserve beta‑cell function in participants newly diagnosed with type 1 diabetes.
Who it's for
Participants newly diagnosed with type 1 diabetes, both children and adults.
What's involved
Participants will receive baricitinib and attend scheduled visits for monitoring and tests.
Time commitment
The study lasts about 60 weeks, with regular visits as scheduled.
  • Phase 3: a large, late-stage study

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 1 to 35

You may be able to join if

  • 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

You likely can't join if

  • 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

The study team makes the final eligibility decision.

Where it is enrolling

  • Aurora, Colorado, United States
  • Tallahassee, Florida, United States
  • Corpus Christi, Texas, United States
  • Charlottesville, Virginia, United States
  • Adelaide, Australia
  • Heidelberg West, Australia
  • Ipswich, Australia
  • Oaklands Park, Australia
  • Parkville, Australia
  • Perth, Australia
  • Randwick, Australia
  • Westmead, Australia
  • Brussels, Belgium
  • Edegem, Belgium
  • Ghent, Belgium
  • Leuven, Belgium
  • Liège, Belgium
  • Namur, Belgium
  • Yvoir, Belgium
  • Campo Grande, Brazil

+ 76 more site(s).

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 1 year to 35 years. The study team makes the final eligibility decision.

Where is this trial taking place?

This study is enrolling now at Aurora, Colorado, United States; Tallahassee, Florida, United States; Corpus Christi, Texas, United States; Charlottesville, Virginia, United States; Adelaide, Australia; Heidelberg West, Australia and 90 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.