Recruiting
Phase 1, Phase 2
A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes

This study will evaluate the safety, tolerability and efficacy of VX-880 infusion in participants with Type 1 diabetes mellitus (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia.

ClinicalTrials.gov Identifier
NCT04786262
Eligibility criteria
Sex
Age
18 Years - 65 Years
Phase
1, 2
Key inclusion criteria
  • Clinical history of T1D with > 5 years of duration
  • 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.
Trial details
Condition
Diabetes Mellitus, Type 1, Impaired Hypoglycemic Awareness, Severe Hypoglycemia
Study duration
March 2021 - January 2028
Study type
Interventional
Intervention/Treatment
Biological : VX-880
Estimated enrollment
17

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About clinical trials

Volunteers who participate in clinical trials help make new medicines a reality. Clinical trials are carefully designed research studies in humans that evaluate the safety and efficacy of an investigational medicine.

If you’re interested in participating in a Vertex clinical trial, we encourage you to speak with your health care provider first about what’s involved and your eligibility. 

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Location
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  • Recruiting
    1
    City of Hope
    Duarte California 91010 United States
  • Recruiting
    1
    UHealth Diabetes Research Institute
    Miami Florida 33136 United States
  • Recruiting
    1
    Northwestern Organ Transplant Center
    Chicago Illinois 60611 United States
  • Recruiting
    1
    University of Chicago
    Chicago Illinois 60637 United States
  • Recruiting
    1
    Massachusetts General Hospital
    Boston Massachusetts 02114 United States
  • Recruiting
    1
    Hospital of the University of Pennsylvania
    Philadelphia Pennsylvania 19104 United States
  • Recruiting
    1
    University of Pittsburgh Medical Center Montefiore
    Pittsburgh Pennsylvania 15213 United States
  • Recruiting
    1
    VCU Medical Center, Richmond
    Richmond Virginia 23298 United States
  • Recruiting
    1
    University of Wisconsin
    Madison Wisconsin 53792 United States