A Safety, Tolerability, and Efficacy Study of VX-264 in Participants With Type 1 Diabetes (NCT05791201) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
A Safety, Tolerability, and Efficacy Study of VX-264 in Participants With Type 1 Diabetes
United States, Canada, Germany7 participantsStarted 2023-05-16
Plain-language summary
The purpose of the study is to evaluate the safety, tolerability, and efficacy of VX-264 in participants with type 1 diabetes (T1D).
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria:
Clinical history of T1D with greater than or equal to (\>=) 5 years duration Participant is on a stable diabetic treatment Consistent use of continuous glucose monitoring (CGM) for at least 4 weeks before Screening and willingness to use CGM for the duration of the study
Key Exclusion Criteria:
Prior islet cell transplant, organ transplant, or cell therapy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a combined Phase 1 and Phase 2 trial for VX-264 in Type 1 Diabetes, what does that mean for how much is already known about its safety, and are there any adverse events or serious adverse events that have already been reported so far?
2The trial is measuring C-peptide levels during a mixed-meal tolerance test as a key outcome — can you explain what a meaningful change in C-peptide would look like for me practically, and what it might or might not tell us about real-world blood sugar control?
3The study is listed as active but no longer recruiting new participants — does that mean there's any possibility of me being considered, or should I be focusing entirely on other options right now?
4Are there standard-of-care treatments or other trials I should consider first before waiting for results from a study like this, especially given that it's still in an early combined phase?
5VX-264 appears to involve an implanted or encapsulated cell therapy approach — what kinds of procedures, monitoring visits, or lifestyle demands would typically be involved in a trial like this, and how might that fit with my current situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Part A and Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: From Day 1 up to 24 months
2
Part B: Change in Peak C-peptide during Mixed-Meal Tolerance Test (MMTT)