Baricitinib for Type 1 Diabetes

(BARICADE-DELAY Trial)

Recruiting at 108 trial locations

Overseen By Physicians interested in becoming principal investigators please contact

Age: < 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Eli Lilly and Company

Disqualifiers: Other diabetes, Heart disease, Stroke, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 5 years

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether baricitinib, a medication, can delay the onset of type 1 diabetes in individuals likely to develop the condition. Participants will receive either baricitinib or a placebo (a pill with no active medicine) to determine any difference in diabetes onset. It may suit those already showing early signs of type 1 diabetes, such as having two or more specific antibodies linked to the disease. As a Phase 3 trial, this represents the final step before FDA approval, providing participants an opportunity to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that baricitinib is likely to be safe for humans?

Research has shown that baricitinib is generally safe for people with type 1 diabetes. In a previous study, patients who took baricitinib daily for 48 weeks maintained healthy beta-cell function, crucial for insulin production. This finding supports its safety and effectiveness.

The FDA has already approved the treatment for other uses, indicating a well-understood safety profile. However, like any medication, baricitinib can cause side effects, commonly mild to moderate issues such as headaches and colds.

Participants in clinical trials must be closely monitored to manage any potential risks. So far, the safety data appears promising for those considering joining a trial with baricitinib for type 1 diabetes. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for type 1 diabetes?

Baricitinib is unique because it offers a fresh approach to managing Type 1 Diabetes by targeting the immune system's role in the disease. Unlike traditional treatments that focus on insulin replacement, Baricitinib works by modulating the immune response, potentially preserving the insulin-producing cells in the pancreas. Researchers are excited because this could mean better control of blood sugar levels and a reduction in the need for insulin injections, ultimately improving quality of life for patients.

What evidence suggests that baricitinib might be an effective treatment for type 1 diabetes?

Research has shown that baricitinib, a type of medication, can slow the progression of type 1 diabetes (T1D). In this trial, participants will receive either baricitinib or a placebo. Studies have found that people taking baricitinib produce more insulin and maintain stable blood sugar levels compared to those on a placebo. This treatment also protects the insulin-producing cells, crucial for blood sugar control, over a 48-week period. Additionally, patients on baricitinib have reported needing less external insulin and spending more time with blood sugar levels in the target range. However, these benefits may decrease if the treatment stops. ^{1 3 4 5 6}

Who Is on the Research Team?

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for individuals at high risk of developing type 1 diabetes (T1D), but who haven't yet been diagnosed with it. The study will last up to about 5 years, and participants must meet specific health criteria not detailed here.

Inclusion Criteria

Have a history of at least one documented occasion of at least two diabetes-related autoantibodies, AND one occasion of at least two diabetes-related autoantibodies obtained at screening or prescreening

My diabetes is classified as Stage 1b or Stage 2.

I weigh at least 18 pounds.

Exclusion Criteria

Have any other type of diabetes

I have had a heart attack, heart disease, stroke, or heart failure.

I have a history or high risk of blood clots or cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive baricitinib or placebo orally to delay the onset of clinical type 1 diabetes

Up to 5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Baricitinib

Trial Overview

The study is testing whether Baricitinib can prevent or delay the onset of clinical T1D in people at high risk. Participants will either receive Baricitinib or a placebo without knowing which one they're getting.

How Is the Trial Designed?

Group I: Baricitinib Experimental Treatment 1 Intervention

Participants will receive baricitinib orally

Group II: Placebo Placebo Group 1 Intervention

Participants will receive placebo orally

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Citations

1.

trialnet.org

trialnet.org/events-news/blog/study-finds-jak-inhibitor-baricitinib-slows-t1d

Groundbreaking study finds JAK inhibitor baricitinib slows ...

Those taking baricitinib continued to produce more insulin and had more stable glucose levels than the placebo group. “This groundbreaking ...

2.

nejm.org

nejm.org/doi/full/10.1056/NEJMoa2306691

Baricitinib and β-Cell Function in Patients with New-Onset ...

In patients with type 1 diabetes of recent onset, daily treatment with baricitinib over 48 weeks appeared to preserve β-cell function.

3.

breakthrought1d.org

breakthrought1d.org/news-and-updates/two-new-trials-baricitinib-to-delay-t1d/

Two new trials investigating baricitinib to delay T1D

The results were positive: people treated with baricitinib had increased insulin production, spent more time-in-range, needed less external ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04774224

NCT04774224 | Baricitinib in New-onset Type 1 Diabetes

The study aims to slow the progressive, immune-mediated loss of insulin-producing beta cells that occurs after clinical presentation.

5.

rheumatologyadvisor.com

rheumatologyadvisor.com/news/loss-of-therapeutic-benefit-seen-after-stopping-baricitinib-in-type-1-diabetes/

Loss of Therapeutic Benefit Seen After Stopping Baricitinib ...

HealthDay News — Two-year follow-up shows a loss of therapeutic benefit when baricitinib treatment is stopped in type 1 diabetes (T1D), ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9443639/

A Review of Safety Outcomes from Clinical Trials ...

A Danish cohort study identified a reduced incidence of CVD, including MI, stroke and CV death, in patients with mild AD [61]. However, a ...