A Safety, Tolerability, and Efficacy Study of VX-264 in Participants With Type 1 Diabetes
- Registration Number
- NCT05791201
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Brief Summary
The purpose of the study is to evaluate the safety, tolerability, and efficacy of VX-264 in participants with type 1 diabetes (T1D).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 7
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
Prior islet cell transplant, organ transplant, or cell therapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description VX-264 VX-264 -
- Primary Outcome Measures
Name Time Method Part A and Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From Day 1 up to 24 months Part B and Part C: Change in Peak C-peptide during Mixed-Meal Tolerance Test (MMTT) From Baseline and at Day 90
- Secondary Outcome Measures
Name Time Method Part C: Proportion of Participants who are Insulin Independent at One Point in Time From Day 180 up to Day 365 Part C: Change in HbA1c values From Baseline up to 24 months Part C: Change in Average Total Daily Insulin Dose From Baseline up to 24 months Part C: Change in peak C-peptide during MMTT From Baseline up to 24 months
Trial Locations
- Locations (16)
UHealth Diabetes Research Institute
🇺🇸Miami, Florida, United States
Montreal Clinical Research Institute
🇨🇦Montreal, Canada
Toronto General Hospital (TGH)
🇨🇦Toronto, Canada
Vancouver General Hospital
🇨🇦Vancouver, Canada
University of Chicago
🇺🇸Chicago, Illinois, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center Montefiore
🇺🇸Pittsburgh, Pennsylvania, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
University of Alberta, Edmonton
🇨🇦Edmonton, Canada
Dresden Center for Islet Transplantation
🇩🇪Dresden, Germany
IRCCS Ospedale San Raffaele
🇮🇹Milan, Italy
Leiden University
🇳🇱Leiden, Netherlands
Hopiteaux Universitaires de Geneve
🇨🇭Geneve, Switzerland
Churchill Hospital
🇬🇧Headington, United Kingdom
Royal Victoria Infirmary
🇬🇧Newcastle Upon Tyne, United Kingdom