RecruitingPhase 3NCT04786262
A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes
A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, and Efficacy of VX-880 in Subjects Who Have Type 1 Diabetes Mellitus With Impaired Hypoglycemic Awareness and Severe Hypoglycemia
Sponsor
Vertex Pharmaceuticals Incorporated
Enrollment
52 participants
Start Date
Mar 29, 2021
Study Type
INTERVENTIONAL
Conditions
Summary
This study will evaluate the safety, tolerability and efficacy of VX-880 infusion in participants with Type 1 diabetes (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia.
Eligibility
Min Age: 18 YearsMax Age: 65 Years
Inclusion Criteria4
- 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 Criteria1
- Prior islet cell transplant, organ transplant, or cell therapy
Interventions
BIOLOGICALVX-880
Infused into the hepatic portal vein.
Locations(29)
View Full Details on ClinicalTrials.gov
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NCT04786262
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