Active not recruitingPHASE1, PHASE2INTERVENTIONAL

A Safety, Tolerability, and Efficacy Study of VX-264 in Participants With Type 1 Diabetes

This research study is investigating a new medication, VX-264, for individuals living with Type 1 Diabetes. The main goals are to understand if VX-264 is safe to use and how well it is tolerated by the body. Researchers also want to find out if it can help improve how Type 1 Diabetes is managed. This study is open to adults between 18 and 65 years old who have had Type 1 Diabetes for at least five years. Participants will need to use a continuous glucose monitor (CGM) throughout the study. This is an early-stage study, meaning it's one of the first times this medicine is being tested in people.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

Vertex Pharmaceuticals Incorporated

Enrolment target

Start

16 May 2023

Estimated completion

12 Mar 2027

Type 1 Diabetes

What is this study about?

This study is focused on a new potential treatment called VX-264 for people living with Type 1 Diabetes. Type 1 Diabetes is a lifelong condition where the body's immune system mistakenly attacks and destroys the cells in the pancreas that produce insulin. Insulin is a vital hormone that helps the body use sugar for energy. People with Type 1 Diabetes need to take insulin every day to manage their blood sugar levels.

The main aim of this study is to carefully look at VX-264. Researchers want to understand if it is safe for people to take, how well their bodies react to it (this is known as 'tolerability'), and if it could be an effective way to help manage Type 1 Diabetes. Finding new treatments like VX-264 is incredibly important because it could offer new options or improvements in care for people with this condition.

By taking part, volunteers will be contributing to vital scientific research that could potentially lead to better future treatments. This early-stage research is crucial for gathering important information that will help decide if VX-264 should be studied further.

Key takeaways

This study is testing a new medicine called VX-264 for Type 1 Diabetes.
It's open to adults aged 18 to 65 who have had Type 1 Diabetes for at least 5 years.
The main goals are to check the medicine's safety, how well people tolerate it, and if it helps.
Participants must be using a continuous glucose monitor (CGM).
It's an early-stage study, meaning it's among the first times VX-264 is being tested in people.
You can stop participating at any time if you choose to.

Who may be eligible?

This study is looking for adults aged between 18 and 65 who have Type 1 Diabetes. To be part of the study, you need to have been diagnosed with Type 1 Diabetes at least five years ago.

You should also be on a stable diabetes treatment plan, meaning your current treatment hasn't changed much recently. You'll also need to be using a continuous glucose monitor (CGM) for at least four weeks before the study starts, and be willing to keep using it throughout the study period.

There are also some reasons why you might not be able to join. For example, if you've had an islet cell transplant (a procedure to put new insulin-producing cells into your body), or any other organ transplant or cell therapy, you wouldn't be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 65 years old?
Have you been living with Type 1 Diabetes for at least 5 years?
Are you currently on a steady diabetes treatment plan?
Do you use a continuous glucose monitor (CGM) regularly?
Have you NOT had an organ transplant or cell therapy?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the new medicine, VX-264, as guided by the study team. You would have regular appointments at the study clinic, where doctors and nurses would check your health and how you're reacting to the medicine. This will involve physical examinations, blood tests, and other checks like measuring your blood sugar levels using your continuous glucose monitor.

These visits are important because they help the researchers understand if the medicine is working and if it's safe. You would also continue to use your continuous glucose monitor throughout the study, providing important information about your blood sugar levels. The full length of your participation, including follow-up care, would be clearly explained to you before you make any decisions.

Potential risks and benefits

Participating in a study like this could offer potential benefits, such as access to a new medicine that isn't widely available yet, and closer monitoring of your health. However, as with any new medicine, there are potential risks. You might experience side effects from VX-264, which will be fully explained to you by the study team. We don't yet know all the possible effects. It's very important to remember that joining a study is always voluntary, and you are free to withdraw at any time, for any reason, without it affecting your usual medical care.

Locations (16)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

UHealth Diabetes Research Institute
Verified postcode
Miami, United States
University of Chicago
Verified postcode
Chicago, United States
Massachusetts General Hospital
Verified postcode
Boston, United States
Hospital of the University of Pennsylvania
Verified postcode
Philadelphia, United States
University of Pittsburgh Medical Center Montefiore
Verified postcode
Pittsburgh, United States
University of Wisconsin
Verified postcode
Madison, United States
University of Alberta, Edmonton
Verified postcode
Edmonton, Canada
Montreal Clinical Research Institute
Verified postcode
Montreal, Canada
Toronto General Hospital (TGH)
Verified postcode
Toronto, Canada
Vancouver General Hospital
Verified postcode
Vancouver, Canada
Dresden Center for Islet Transplantation
Verified postcode
Dresden, Germany
IRCCS Ospedale San Raffaele
Verified postcode
Milan, Italy

Common questions

What is Type 1 Diabetes?

Type 1 Diabetes is a condition where your body stops making insulin, a hormone needed to turn food into energy. People with Type 1 Diabetes need daily insulin injections or an insulin pump.

What is VX-264?

VX-264 is a new medicine being tested in this study. We are researching if it is safe and if it can help people with Type 1 Diabetes.

What is a 'Phase 1/2' study?

This means it's an early-stage study. Phase 1 studies mainly check for safety and dose, while Phase 2 studies look at both safety and how well the treatment works.

Will I still take my usual diabetes medicines?

You will need to be on a stable diabetes treatment. The study team will explain how VX-264 might fit with your current medicines.

Do I have to pay to join the study?

No, you do not have to pay to participate in the study. All study-related care and medication are provided.