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

RECRUITINGPhase 3Sponsored by Vertex Pharmaceuticals Incorporated
Actively Recruiting
PhasePhase 3
SponsorVertex Pharmaceuticals Incorporated
Started2021-03-29
Est. completion2027-06-30
Eligibility
Age18 Years – 65 Years
Healthy vol.Accepted
Locations12 sites
View on ClinicalTrials.gov →

NCT04786262

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

Age: 18 Years – 65 YearsHealthy volunteers accepted
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

Conditions4

DiabetesDiabetes Mellitus, Type 1Impaired Hypoglycemic AwarenessSevere Hypoglycemia

Locations12 sites

City of Hope
Duarte, California, 91010
University of California San Francisco
San Francisco, California, 94143
UHealth Diabetes Research Institute
Miami, Florida, 33136
Northwestern Organ Transplant Center
Chicago, Illinois, 60611
University of Chicago
Chicago, Illinois, 60637

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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