RecruitingPHASE3INTERVENTIONAL

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

This research study is looking into a medication named baricitinib. We want to see if this drug can help save the insulin-producing cells (beta cells) in people who have recently been diagnosed with type 1 diabetes. These cells are really important because they make the insulin your body needs to control blood sugar. By trying to protect these cells, we hope to understand if it can help people manage their diabetes more easily. The study involves both children and adults aged 1 to 35 who have just found out they have type 1 diabetes. Participants will be in the study for about 60 weeks to see if the treatment makes a difference compared to a dummy pill (placebo).

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Eli Lilly and Company

Enrolment target

300

Start

05 Feb 2026

Estimated completion

01 Jul 2028

Diabetes Mellitus, Type 1

What is this study about?

This study, called BARICADE-PRESERVE, is about helping people who have recently been diagnosed with type 1 diabetes. When someone has type 1 diabetes, their body's immune system mistakenly attacks and destroys special cells in the pancreas called beta cells. These beta cells are vital because they produce insulin, a hormone essential for controlling blood sugar levels.

The main goal of this study is to find out if a medicine called baricitinib can help protect these remaining beta cells from being destroyed. If we can save more of these cells, it might mean the body can still make some of its own insulin, which could potentially make managing type 1 diabetes a bit easier for patients.

Researchers want to see if baricitinib can preserve this important function over time. Participants, including children and adults, will be given either baricitinib or a dummy pill (placebo) to compare the effects, but they won't know which one they are receiving. This helps make sure the results are reliable and not influenced by expectations.

Key takeaways

This study tests a drug called baricitinib to protect insulin-making cells in new type 1 diabetes patients.
It involves children and adults aged 1 to 35 who were recently diagnosed.
The goal is to see if preserving these cells can help manage diabetes better.
Participants will receive either baricitinib or a dummy pill for about 60 weeks.
Regular health checks and blood tests will be part of the study.
Your safety will be closely monitored throughout.

Who may be eligible?

This study is for people who have been diagnosed with type 1 diabetes recently – specifically, within the last 100 days (about 3 months and a bit) before starting the study treatment. Participants need to be between 1 and 35 years old.

To join, your doctors need to confirm that you have specific markers in your blood related to type 1 diabetes (called autoantibodies). Also, it's important that your body is still showing some signs of producing insulin, even a small amount. This is measured by checking a substance called C-peptide.

However, you won't be able to join if you have other types of diabetes, such as gestational diabetes. We also can't include you if you have serious heart problems like a recent heart attack, or if you have uncontrolled high blood pressure. People who have had certain blood clots, cancer, or a current serious infection also can't take part. This is to ensure the safety of everyone in the study.

Quick self-check

Are you between 1 and 35 years old?
Have you been diagnosed with type 1 diabetes within the last 3 months and a bit?
Has your doctor confirmed you have certain markers for type 1 diabetes in your blood?
Are your doctors seeing some signs that your body is still making a little bit of insulin?
Do you *not* have other types of diabetes or serious heart problems?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you'll be in the study for about 60 weeks, which is just over a year. During this time, you'll receive either the study medicine, baricitinib, or a placebo (a dummy pill that looks like the real thing but has no active drug). You won't know which one you are taking.

You will have several visits to the clinic for check-ups and tests. These will include blood tests to measure your C-peptide levels (to see how your insulin-producing cells are doing), and other general health checks. The medical team will monitor your health closely throughout the study. All study medication and assessments will be provided at no cost, and you can stop participating at any time.

Potential risks and benefits

Taking part in a study like this might offer a potential benefit: if baricitinib works, it could help protect your insulin-producing cells, which might make managing your type 1 diabetes easier in the long run. However, there's no guarantee the treatment will work for you, and there could be side effects from the medication. Your doctor will discuss all known possible risks with you. Remember, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (132)

Barbara Davis Center for Childhood Diabetes
Aurora, United States· Not yet recruiting
Tallahassee Memorial HealthCare
Tallahassee, United States· Not yet recruiting
Children's Hospital of Philadelphia (CHOP)
Philadelphia, United States· Not yet recruiting
Driscoll Children's Hospital
Corpus Christi, United States· Not yet recruiting
University of Virginia
Charlottesville, United States· Not yet recruiting
Women's and Children's Hospital
Adelaide, Australia· Recruiting
Centre for Children's Health Research
Brisbane, Australia· Not yet recruiting
Austin Health - Repatriation Hospital
Heidelberg West, Australia· Recruiting
Ipswich Hospital
Ipswich, Australia· Recruiting
Royal Children's Hospital
Melbourne, Australia· Not yet recruiting
Southern Adelaide Diabetes & Endocrine Services
Oaklands Park, Australia· Recruiting
The Royal Melbourne Hospital
Parkville, Australia· Recruiting

+120 more sites — see the official record for the full list.

Common questions

What is baricitinib?

Baricitinib is a medicine that helps calm down the immune system. We are testing if it can stop the immune system from attacking the insulin-producing cells in type 1 diabetes.

What are 'beta cells'?

Beta cells are special cells in your pancreas that make insulin, which your body needs to control blood sugar. In type 1 diabetes, these cells are attacked and destroyed.

What does 'newly diagnosed' mean in this study?

It means you must have been diagnosed with type 1 diabetes within 100 days (about three months) before you would start taking the study medication.

Will I know if I'm getting the real medicine or the placebo?

No, you won't know. To make the study fair, neither you nor the study team will know who is getting the real drug and who is getting the dummy pill until the study ends.

How long will I be in the study?

Participation in the study will last for about 60 weeks, which is a little over a year.

How to find out more

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

LillyTrials@Lilly.com 317-615-4559 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.