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A Safety, Tolerability, and Efficacy Study of VX-264 in Subjects With Type 1 Diabetes
EU CTIS ID: 2024-515583-32-00
What this study is testing
1. Evaluate the safety and tolerability of VX-264 in subjects with T1D (Part A and Part B). 2. Evaluate VX-264 function in subjects with T1D (Part B)
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subjects (male and female) between the ages of 18 and 65 years (inclusive) on the date of first informed consent.
- HbA1c ≥6.0% and ≤9.5%.
- Clinical history and laboratory evidence of T1D based on the American Diabetes Association/European Association for the Study of Diabetes algorithm 13 for investigation of suspected T1D including: o insulin dependence for ≥5 years at time of Screening, and o peak stimulated C-peptide level during MMTT <50 pmol/L (<0.15 ng/mL)
- Consistent use of CGM for at least 4 weeks before Screening and willingness to use only the study-provided CGM for the duration of the study.
- Body habitus supportive of implantation of the planned number of VX- 264 units per study part and/or cohort.
You likely can't join if
- Prior islet cell transplant, organ transplant, or cell therapy.
- Advanced complications associated with diabetes including untreated proliferative retinopathy, diabetic nephropathy, skin ulcers, or amputations attributable to diabetes.
- Insulin requirement: a) Parts A and B >40 U/day, or <10 U/day b) >0.8 U/kg/day.
- Subjects with ≥2 or more episodes of severe hypoglycemia in the 12 months prior to signing of informed consent at Screening.
- Previous abdominal or abdominal wall surgery, or history of peritonitis, that can impact VX-264 placement or put the patient at higher risk of surgical complications.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Switzerland
- United Kingdom
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Switzerland; United Kingdom; Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.