Tests VX-880 and VX-017 cell therapies in type 1 diabetes with low blood sugar
Tests VX-880 and VX-017 infusions in adults with type 1 diabetes and dangerous lows.
Plain-language title generated from the registry record
Registry title: A Safety, Tolerability, and Efficacy Study of VX-880 and VX-017 in Participants With Type 1 Diabetes
Key facts
- Where
- Baltimore, Boston, Chicago, Dallas, Duarte, Madison, Miami, Philadelphia, Pittsburgh, Richmond, and San Francisco, United StatesSee the 12 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT04786262, who can take part
Where in United States
- Johns Hopkins UniversityBaltimore, United StatesNo longer taking part
- Massachusetts General HospitalBoston, United StatesTaking people
- University of ChicagoChicago, United StatesTaking people
- Northwestern Organ Transplant CenterChicago, United StatesNo longer taking part
- Baylor, Scott and White Research InstituteDallas, United StatesTaking people
- City of HopeDuarte, United StatesTaking people
- University of WisconsinMadison, United StatesTaking people
- UHealth Diabetes Research InstituteMiami, United StatesTaking people
- Hospital of the University of PennsylvaniaPhiladelphia, United StatesTaking people
- University of Pittsburgh Medical Center MontefiorePittsburgh, United StatesTaking people
- VCU Medical Center, RichmondRichmond, United StatesTaking people
- University of California San FranciscoSan Francisco, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Vertex Pharmaceuticals Incorporated
- Trial code
- NCT04786262EU 2024-513929-23-00
- Record updated
- 1 September 2026
- Original description
This study will evaluate the safety, tolerability and efficacy of VX-880 infusion and VX-017 infusion in participants with type 1 diabetes (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia.Read full original descriptionShow less
A Master Protocol to Evaluate the Safety, Tolerability, and Efficacy of Islet Cell Replacement Therapies in Subjects Who Have Type 1 Diabetes Mellitus With Impaired Hypoglycemic Awareness and Severe Hypoglycemia: A Phase 1/2/3 Study of VX-880 and a Phase 1/2 Study of VX-017
This study will evaluate the safety, tolerability and efficacy of VX-880 infusion and VX-017 infusion in participants with type 1 diabetes (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia.
Inclusion: Clinical history of T1D with >=5 years of duration of insulin dependence; At least two episodes of documented severe hypoglycemia in the 12 months prior to enrollment; Stable diabetic treatment; Consistent use of continuous glucose monitor (CGM) for at least 3 months before Screening and willingness to use CGM for the duration of the study.
Exclusion: -Prior islet cell transplant, organ transplant, or cell therapy; Other protocol-defined Inclusion/Exclusion criteria may apply.