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A Safety, Tolerability, and Efficacy Study of VX-880 and VX-017 in Participants With Type 1 Diabetes
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
Who can join
Ages 18 to 65 · All sexes
Full eligibility criteria
Key Inclusion Criteria: * 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 Key Exclusion Criteria: -Prior islet cell transplant, organ transplant, or cell therapy Other protocol-defined Inclusion/Exclusion criteria may apply
About the study
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.
What is being tested
- VX-880 (biological)
- VX-017 (biological)
Sponsor: Vertex Pharmaceuticals Incorporated · Participants: 57 · Started: Mar 29, 2021
Contact the study team
- Medical Information · Phone: 617-341-6777
Official record on ClinicalTrials.gov — NCT04786262
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.