RecruitingPHASE3INTERVENTIONAL

A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes

This research study is about a new treatment called VX-880 for individuals living with Type 1 diabetes. The main goal is to check how safe this treatment is, how well people tolerate it (meaning, how they feel when they receive it), and if it actually works. We are focusing on people with Type 1 diabetes who have difficulty noticing when their blood sugar levels become dangerously low (this is called 'impaired hypoglycaemic awareness') and who have experienced several severe low blood sugar episodes. The study involves giving VX-880 as an infusion (like a drip). By taking part, you could help us understand if this new treatment can make a real difference for people struggling with these serious challenges of Type 1 diabetes.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Vertex Pharmaceuticals Incorporated

Enrolment target

Start

29 Mar 2021

Estimated completion

30 Jun 2030

Diabetes Mellitus, Type 1 Impaired Hypoglycemic Awareness Severe Hypoglycemia

What is this study about?

This study is exploring a new treatment called VX-880, which is given as an infusion, for people who have Type 1 diabetes. We know that living with Type 1 diabetes can be very challenging, and for some people, it's even more difficult because they don't realise when their blood sugar levels drop too low. This is called 'impaired hypoglycaemic awareness'. When blood sugar drops very low, it's known as 'severe hypoglycaemia', and it can be a serious medical emergency.

The main aim of this study is to find out three key things about VX-880: first, is it safe for people to use? Second, do people tolerate it well, meaning do they feel comfortable with the treatment and experience manageable side effects, if any? And third, is it effective? Does it actually help reduce the problems related to not recognising low blood sugar or prevent severe low blood sugar episodes?

By carefully studying VX-880, researchers hope to develop better ways to manage Type 1 diabetes, especially for those who face these specific and serious challenges. If successful, this research could potentially improve the quality of life and safety for many individuals with Type 1 diabetes in the future.

Key takeaways

This study is for adults with Type 1 diabetes who have problems noticing low blood sugar.
It's testing a new treatment called VX-880 given as an infusion.
The study aims to see if VX-880 is safe, well-tolerated, and effective in preventing severe low blood sugar.
Participants must have used a continuous glucose monitor (CGM) and be willing to continue using it.
You can discuss any concerns or questions with the study team at any time.

Who may be eligible?

This study is looking for adults aged between 18 and 65 years old, regardless of whether they are male or female. To join, you need to have been diagnosed with Type 1 diabetes for at least five years and relied on insulin during that time. A really important part of joining is that you must have experienced at least two serious low blood sugar episodes, where you needed help from someone else, within the last year.

Also, your current diabetes treatment needs to be stable, meaning it hasn't changed much recently. You must also have been consistently using a continuous glucose monitor (CGM), which is a device that tracks your blood sugar levels, for at least three months before you join, and be willing to keep using it throughout the study.

There are also some reasons why you wouldn't be able to join. For example, if you've already had a special type of transplant involving pancreas cells (called an islet cell transplant), any other organ transplant, or another type of cell therapy, you wouldn't be eligible. The study team will check other rules before you can take part.

Quick self-check

Are you 18 to 65 years old?
Do you have Type 1 diabetes and have you been insulin-dependent for more than 5 years?
Have you had at least two serious low blood sugar episodes in the past year, where someone else had to help you?
Have you been regularly using a continuous glucose monitor (CGM) for at least 3 months?
Have you *not* had an islet cell transplant or any other organ/cell transplant?

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 in this study, you'll receive the new treatment called VX-880 through an infusion, which is like a drip. The study team will carefully monitor your health and blood sugar levels throughout. You will need to attend several appointments at the study clinic for assessments and monitoring. These appointments will involve checking your general health, blood tests, and other specific tests to see how you are responding to the treatment.

You will need to continue using your continuous glucose monitor (CGM) throughout the study, as this helps track your blood sugar levels closely. The total length of your participation in the study will be explained by the study team, and it involves a series of regular visits and follow-up checks. All the specific details, including the number of visits, tests, and the timeframe, will be discussed with you before you agree to join.

Potential risks and benefits

Taking part in a study like this can have potential benefits. If VX-880 is effective, it could help reduce the number of severe low blood sugar episodes and improve your ability to notice when your blood sugar is dropping, potentially leading to better health and safety. However, like any new treatment, there are potential risks. You might experience side effects from the infusion or the new medication, though these would be carefully monitored by the study team. There might also be discomfort or minor risks associated with blood tests and other medical procedures. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (29)

City of Hope
Duarte, United States· Recruiting
University of California San Francisco
San Francisco, United States· Recruiting
UHealth Diabetes Research Institute
Miami, United States· Recruiting
Northwestern Organ Transplant Center
Chicago, United States· Completed
University of Chicago
Chicago, United States· Recruiting
Johns Hopkins University
Baltimore, United States· Recruiting
Massachusetts General Hospital
Boston, United States· Recruiting
Hospital of the University of Pennsylvania
Philadelphia, United States· Recruiting
University of Pittsburgh Medical Center Montefiore
Pittsburgh, United States· Recruiting
Baylor Scott and White Research Institute
Dallas, United States· Recruiting
VCU Medical Center, Richmond
Richmond, United States· Recruiting
University of Wisconsin
Madison, United States· Recruiting

+17 more sites — see the official record for the full list.

Common questions

What exactly is VX-880?

VX-880 is a new treatment being tested in this study for people with Type 1 diabetes. It's given as an infusion (like a drip) and aims to help with managing blood sugar levels, especially for those who struggle with severe low blood sugar.

What is 'impaired hypoglycaemic awareness'?

This means you have trouble noticing or feeling the warning signs when your blood sugar levels drop too low. This can be dangerous because you might not realise you need to act quickly.

Will I still need to take my usual insulin?

Yes, you will continue your stable diabetes treatment, including insulin, during the study. The study team will give you full instructions.

What is a continuous glucose monitor (CGM)?

A CGM is a small device worn on the body that continuously measures and tracks your blood sugar levels throughout the day and night, giving you and your healthcare team a clearer picture of your glucose trends.

How long will I be in the study?

The exact duration for your participation will be explained by the study team. It involves a series of visits and follow-up checks over a specific period.

How to find out more

Medical Information

medicalinfo@vrtx.com 617-341-6777 Official trial record

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