Baricitinib for Type 1 Diabetes

Not yet recruiting at 129 trial locations

Overseen By There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Age: < 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Eli Lilly and Company

Disqualifiers: Other diabetes, Hypertension, Heart disease, 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: 52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether the drug baricitinib, a Janus kinase inhibitor, can protect the body's beta cells, which are crucial for insulin production, in individuals newly diagnosed with type 1 diabetes. Participants will take either baricitinib or a placebo (a pill with no active medication) for about 60 weeks. The trial seeks individuals diagnosed with type 1 diabetes within the last 100 days who still have some beta cell activity. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment for type 1 diabetes.

Will I have to stop taking my current medications?

The trial information does not specify if 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 this trial's treatments are likely to be safe?

Research has shown that baricitinib, a drug tested for type 1 diabetes, was well-tolerated in earlier studies. In individuals with recent type 1 diabetes, taking baricitinib daily for 48 weeks appeared to protect beta cells, which are crucial for insulin production. Participants in these studies showed positive outcomes, such as increased insulin production and healthier blood sugar levels.

Baricitinib is part of a group of drugs called JAK inhibitors, which have been found safe and effective in slowing the disease in newly diagnosed individuals with type 1 diabetes. Although baricitinib is being tested for type 1 diabetes, it is already FDA-approved for other conditions, indicating a known safety profile. However, like any treatment, risks may exist, so discussing these with a healthcare provider is important. ^{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 new approach for treating Type 1 Diabetes by targeting the JAK-STAT signaling pathway, which plays a role in immune response and inflammation. Unlike traditional treatments that focus on insulin replacement, Baricitinib aims to modulate the immune system to potentially protect pancreatic beta cells from autoimmune attack. Researchers are excited about its potential to not only manage blood sugar levels but also to address the underlying autoimmune process, which could lead to better long-term outcomes for patients.

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

Research has shown that baricitinib, which participants in this trial may receive, might help people with type 1 diabetes by protecting the insulin-producing cells in the pancreas. In earlier studies, participants who took baricitinib produced more insulin and maintained steadier blood sugar levels compared to those on a placebo. Over 48 weeks, baricitinib appeared to safeguard these cells, reducing the need for external insulin. However, these benefits might decrease if the treatment stops. ^{1 2 3 4 6}

Who Is on the Research Team?

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 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 children and adults newly diagnosed with type 1 diabetes who have at least one diabetes-related autoantibody, signs of remaining beta-cell function, weigh at least 8 kg, and do not have other types of diabetes or serious medical conditions like heart disease or uncontrolled high blood pressure.

Inclusion Criteria

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, or random C-peptide result >0.3 nmol/L (0.9 ng/mL) during the screening period

I weigh at least 18 pounds.

Exclusion Criteria

Have any other type of diabetes including gestational

My high blood pressure is not under control.

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

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 assess preservation of beta-cell function

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Baricitinib

Trial Overview The study tests if Baricitinib can help preserve the functioning of beta cells in the pancreas that produce insulin. Participants will either receive Baricitinib or a placebo over approximately 60 weeks to compare outcomes.

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 ... The risk of CV disease (CVD) in RA is estimated to be higher than in the general population (Table 1), by 48% in a meta-analysis of ...