A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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
EXCLUSION CRITERIA
Key Exclusion Criteria:
-Prior islet cell transplant, organ transplant, or cell therapy
Other protocol defined Inclusion/Exclusion criteria may apply
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Diabetes Mellitus, Type 1,Impaired Hypoglycemic Awareness,Severe Hypoglycemia
Age
18 - 65
Phase
PHASE3
Participants Needed
52
Est. Completion Date
Jun 30, 2030
Treatment Type
INTERVENTIONAL
Sponsor
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov NCT Identifier
NCT04786262
Study Number
VX20-880-101
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