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A Study of Baricitinib to Preserve Beta Cell Function in Children and Adults Newly Diagnosed With Type 1 Diabetes

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study involves people who have been newly diagnosed with Type 1 Diabetes. Type 1 Diabetes is a condition where the body's immune system attacks and destroys cells in the pancreas called beta cells, which are responsible for making insulin. Insulin is a hormone that helps control blood sugar levels. The study will test a medication called baricitinib, which will be given as either film-coated tablets or as an oral suspension, which is a liquid form of the medicine. Some participants will receive placebo instead of the actual medication.

The goal of this study is to see if baricitinib works better than placebo in protecting the remaining beta cells in people who have just been diagnosed with Type 1 Diabetes. The study will measure this by looking at a substance in the blood called C-peptide, which shows how much insulin the body is still able to make on its own. The treatment period will last for 52 weeks, which is about one year.

During the study, participants will take the medication by mouth on a regular schedule. The study is designed so that neither the participants nor the doctors will know who is receiving the actual medication and who is receiving placebo until the study is completed. This type of study design helps ensure that the results are accurate and unbiased. Throughout the study, participants will have regular visits where blood samples will be collected to measure C-peptide levels and to monitor their overall health and diabetes management.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Treatment period begins

    Upon joining the study, treatment will begin. The study duration is expected to run from January 2026 until May 2028.

    This is a double-blind study, which means neither the patient nor the medical staff will know whether the patient is receiving the active medication or a placebo (an inactive substance that looks like the medication but contains no active ingredient).

  2. Step 2

    Medication administration

    The patient will receive either baricitinib or a placebo. Baricitinib is a medication being tested to help preserve the function of beta cells, which are the cells in the pancreas that produce insulin.

    The medication or placebo will be taken by mouth. The form may be a tablet or an oral suspension (a liquid that contains the medication).

    The patient will continue taking the assigned medication or placebo for 52 weeks (approximately one year).

  3. Step 3

    Monitoring of beta cell function

    At the beginning of the study (baseline) and at week 52, the patient will undergo testing to measure C-peptide levels.

    C-peptide is a substance in the blood that indicates how much insulin the body is producing. This measurement helps determine if the beta cells are still functioning.

    The measurement will be done using a method called Area Under the Curve, which tracks C-peptide levels over a period of time after a specific test.

  4. Step 4

    Completion of treatment period

    After 52 weeks of treatment, the main treatment period will be completed.

    The change in C-peptide levels from the start of the study to week 52 will be analyzed to determine if the medication helped preserve beta cell function.

Who can join the trial?

5 criteria

  • You must have a new diagnosis of type 1 diabetes, which is a condition where your body does not produce enough insulin to control blood sugar levels
  • You must have at least one autoantibody in your blood that is associated with diabetes at the time of screening. An autoantibody is a special protein that your immune system makes, and it can be detected through a blood test
  • You must weigh at least 8 kilograms, which is about 18 pounds, at the time of screening
  • You can be male or female
  • You can be a child, teenager, or adult

Who cannot join the trial?

5 criteria

  • The study information provided does not list specific reasons why patients cannot participate in this clinical trial
  • If you have Type 1 Diabetes, which is a condition where your body does not produce insulin (a hormone that helps control blood sugar levels), you may be eligible for this study
  • This trial is looking at participants with new-onset diabetes, meaning the disease has been recently diagnosed
  • The study includes both children and younger adults
  • Both male and female participants can take part in this study
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Investigated drugs

Baricitinib is a medicine being tested in this study to see if it can help protect the cells in the pancreas that make insulin in people who have been recently diagnosed with type 1 diabetes. The goal is to find out if this medication can help preserve the body's ability to produce its own insulin for a longer period of time compared to placebo.

Placebo is an inactive substance that looks like the real medication but contains no active medicine. It is used in this study to compare the effects of baricitinib against no treatment, helping researchers understand if the medication is truly effective.

What is already known about the treatment

Baricitinib – Baricitinib is a medication typically taken by mouth in tablet form that works by blocking certain proteins called Janus kinases, which play a role in the immune system's inflammatory responses. In this clinical trial, it is being studied as an experimental treatment to help preserve the body's ability to produce insulin in people newly diagnosed with Type 1 Diabetes, though this use is still under investigation and not yet approved. The drug works at a molecular level by inhibiting specific enzymes that trigger immune cells to attack insulin-producing beta cells in the pancreas. Baricitinib belongs to a class of drugs called JAK inhibitors, which are designed to reduce harmful immune system activity.

Investigated diseases

Type 1 Diabetes Mellitus – Type 1 Diabetes Mellitus is a chronic condition in which the pancreas produces little or no insulin, a hormone needed to allow sugar to enter cells to produce energy. This occurs because the body's immune system mistakenly attacks and destroys the insulin-producing beta cells in the pancreas. The disease typically develops quickly over weeks or months, with symptoms including increased thirst, frequent urination, extreme hunger, and unexplained weight loss. Without insulin, sugar builds up in the bloodstream instead of being used by cells for energy. The condition most commonly begins in childhood or adolescence, but can occur at any age. People with this disease require lifelong insulin replacement to survive and maintain normal blood sugar levels.
Trial detailsLast updated 14 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522170-36-00Protocol code14V-MC-JAJKEstimated enrolment300 patientsSponsorEli Lilly & Co.

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