Status:
RECRUITING
A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Conditions:
Diabetes Mellitus, Type 1
Impaired Hypoglycemic Awareness
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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 Criteria
Inclusion
- Key
- 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
- Prior islet cell transplant, organ transplant, or cell therapy
- Other protocol defined Inclusion/Exclusion criteria may apply
Key Trial Info
Start Date :
March 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2030
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04786262
Start Date
March 29 2021
End Date
June 30 2030
Last Update
August 1 2025
Active Locations (29)
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1
City of Hope
Duarte, California, United States, 91010
2
University of California San Francisco
San Francisco, California, United States, 94143
3
UHealth Diabetes Research Institute
Miami, Florida, United States, 33136
4
Northwestern Organ Transplant Center
Chicago, Illinois, United States, 60611