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.
Key facts
- Who runs it
- Vertex Pharmaceuticals Incorporated
- Where
- Edmonton, Montreal, Toronto, and Vancouver, CanadaSee the 4 sitesAlso in 9 other countries, 25 sites
- Registry title
- A Safety, Tolerability, and Efficacy Study of VX-880 and VX-017 in Participants With Type 1 Diabetes
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 57 people, planned
- Started
- 29 Mar 2021
- Expected to end
- 31 Dec 2031
- Type of study
- Interventional, 2 groups
- Treatments tested
- VX-880
- VX-017
- Record updated
- 1 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with type 1 diabetes who have had severe low blood sugar episodes and have trouble sensing when their blood sugar drops.
- Age
- 18 to 65 years
- Sex
- All sexes can join.
- Disease stage
- Type 1 diabetes with impaired awareness of low blood sugar (hypoglycemia) and severe hypoglycemia; insulin dependence for at least 5 years.
- Earlier treatment
- Stable diabetes treatment is needed. People who have had an islet cell transplant, an organ transplant, or cell therapy cannot join.
Main reasons for not taking part
- Prior islet cell transplant
- Prior organ transplant
- Prior cell therapy
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- 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
Who cannot take part
- -Prior islet cell transplant, organ transplant, or cell therapy
- Other protocol-defined Inclusion/Exclusion criteria may apply
Check if you might fit
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?
Where in Canada
Also in 9 other countries, 25 sites
- University of Alberta EdmontonEdmonton, CanadaTaking people
- McGill University Health CentreMontreal, CanadaTaking people
- Toronto General Hospital (TGH)Toronto, CanadaTaking people
- Vancouver General HospitalVancouver, CanadaTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- VX-880Treatment being tested
- VX-017Treatment being tested
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- 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
- Plain-language title
- Tests VX-880 and VX-017 cell therapies in type 1 diabetes with low blood sugarGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT04786262, who can take part
- Publications
- Record updated
- 1 September 2026