Study on the Safety and Effectiveness of VX-880 for Patients with Type 1 Diabetes and Severe Low Blood Sugar Awareness

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What is this study about?

This clinical trial is focused on studying Type 1 Diabetes Mellitus, a condition where the body cannot produce insulin, leading to high blood sugar levels. The study is testing a new treatment called VX-880 solution for infusion, which is a type of cell therapy. This treatment is designed to help people with Type 1 Diabetes who have difficulty recognizing low blood sugar levels, known as impaired hypoglycemic awareness, and who experience severe low blood sugar episodes, also known as severe hypoglycemia.

The purpose of the study is to evaluate how safe and effective the VX-880 treatment is for these patients. Participants in the study will receive the treatment through a process called infusion, where the solution is delivered directly into the body. The study will monitor participants over time to see how well they tolerate the treatment and whether it helps them manage their diabetes better. This includes checking if they can reduce or stop using insulin and if they experience fewer episodes of severe low blood sugar.

Throughout the study, participants will be closely observed to ensure their safety and to track any changes in their health. The study aims to provide valuable information on whether VX-880 can be a beneficial treatment option for people with Type 1 Diabetes who struggle with severe low blood sugar and impaired awareness of these episodes.

1 initial assessment

The study begins with an initial assessment to confirm eligibility. This includes reviewing the clinical history and laboratory evidence of type 1 diabetes mellitus with impaired hypoglycemic awareness and severe hypoglycemia.

Eligibility criteria include having at least two episodes of severe hypoglycemia in the 12 months prior to the study, reduced awareness of hypoglycemia, and consistent use of a continuous glucose monitor for at least three months before the study.

2 infusion of VX-880

Participants receive an infusion of VX-880, a solution administered through intraportal use. This is a key part of the study aimed at evaluating the safety, tolerability, and efficacy of the treatment.

The infusion involves a total of 0.8 × 10E9 SC-islet cells, administered once.

3 monitoring and follow-up

Participants are monitored for safety and tolerability, focusing on any treatment-emergent adverse events, clinical laboratory values, vital signs, and imaging findings.

The primary goal is to assess the proportion of participants who achieve insulin independence by Day 365 after the infusion.

4 evaluation of outcomes

Secondary outcomes include the proportion of participants free of severe hypoglycemic events from Day 90 to Day 365, and changes in HbA1c levels, which is a measure of blood sugar control.

Other outcomes include the reduction in insulin dose, maintenance of insulin independence, and achieving a target HbA1c of less than 7% over time.

5 long-term follow-up

Participants are followed up to assess the total duration of insulin independence and freedom from exogenous insulin.

The study aims to evaluate the long-term safety and efficacy of the treatment, with an estimated end date in December 2030.

Who Can Join the Study?

Have a clinical history and laboratory evidence of Type 1 Diabetes (T1D). This means you have been diagnosed with T1D and have test results to prove it.
Experienced at least 2 episodes of severe hypoglycemia in the past 12 months. Severe hypoglycemia is when your blood sugar drops very low, causing serious symptoms.
Have reduced awareness of hypoglycemia. This means you may not notice when your blood sugar is getting too low.
Use a continuous glucose monitor (CGM) consistently for at least 3 months before the study starts. A CGM is a device that tracks your blood sugar levels throughout the day and night. If CGM is not commonly used in your area, you may not need to meet this requirement.
Have a compatible blood group, specifically blood type A or AB.
Be within the specified age range for the study.
Both male and female participants are eligible.

Who Cannot Join the Study?

Having a medical condition other than Type 1 Diabetes Mellitus with impaired hypoglycemic awareness and severe hypoglycemia. This means if you have another health issue that affects your blood sugar levels and your ability to notice low blood sugar, you may not be eligible.
Being outside the specified age range for the study. The study has specific age requirements, and if you are not within this range, you cannot participate.
Belonging to a group that is not included in the study. The study may be looking for specific groups of people, and if you are not part of these groups, you may not be eligible.
Being part of a vulnerable population that the study does not include. This means if you are in a group that needs special protection, you might not be able to join the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Lille	Lille	France
Technische Universitaet Dresden	Dresden	Germany

Other Sites

Site Name	City	Country
Ospedale San Raffaele S.r.l.	Milan	Italy
Oazz Uemgwvonrr Hccaziux Hc	Oslo	Norway
Ldmyq Updugtawmqmf Mbdzfum Conhoyz (rlcuj	Leiden	The Netherlands
Hphyyboz Uiubfrfoxfucyn Sjqdgubjdw &swekpq Hktrzky dx Hpaizvskcok	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	25.05.2023
Germany	Recruiting	25.05.2023
Italy	Recruiting	25.05.2023
Norway	Recruiting	25.05.2023
The Netherlands	Recruiting	25.05.2023

Trial locations

Investigated drugs:

ZIMISLECEL

VX-880 is an investigational medication being studied for its potential to help people with Type 1 Diabetes who have difficulty recognizing low blood sugar levels and experience severe drops in blood sugar. The study aims to assess how safe and effective VX-880 is when given to these individuals.

Investigated diseases:

Diabetes mellitus

Type 1 Diabetes Mellitus with Impaired Hypoglycemic Awareness and Severe Hypoglycemia – This condition is a form of Type 1 Diabetes where the body’s immune system attacks insulin-producing cells in the pancreas, leading to little or no insulin production. Individuals with this condition have difficulty recognizing the symptoms of low blood sugar, known as impaired hypoglycemic awareness. This can result in severe hypoglycemia, where blood sugar levels drop dangerously low without warning. The progression involves frequent episodes of low blood sugar, which can occur suddenly and without the usual warning signs. Over time, this can lead to increased risk of severe hypoglycemic events, which require immediate intervention to prevent complications. The condition requires careful monitoring and management to maintain stable blood sugar levels.

Trial ID:

2024-513929-23-00

Protocol code:

VX20-880-101

NCT ID:

NCT04786262

Trial Phase:

Therapeutic use (Phase IV)

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Study on the Safety and Effectiveness of VX-880 for Patients with Type 1 Diabetes and Severe Low Blood Sugar Awareness

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