Recruiting PHASE3 Diabetes Mellitus, Type 1

New treatment option for Diabetes Mellitus, Type 1

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?

Baricitinib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for diabetes mellitus, type 1.

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 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.
  • 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's taking place

  • Aurora, Colorado, United States
  • Tallahassee, Florida, United States
  • Philadelphia, Pennsylvania, United States
  • Corpus Christi, Texas, United States
  • Charlottesville, Virginia, United States
  • Adelaide, Australia
  • Brisbane, Australia
  • Heidelberg West, Australia
  • Ipswich, Australia
  • Melbourne, Australia
  • Oaklands Park, Australia
  • Parkville, Australia
  • Perth, Australia
  • Randwick, Australia
  • Westmead, Australia
  • Brussels, Belgium
  • Edegem, Belgium
  • Ghent, Belgium
  • Leuven, Belgium
  • Liège, Belgium

+ 99 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 - 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?

Study sites include Aurora, Colorado, United States; Tallahassee, Florida, United States; Philadelphia, Pennsylvania, United States; Corpus Christi, Texas, United States; Charlottesville, Virginia, United States; Adelaide, Australia and 113 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.