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 mellitus (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
- 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’s details
Contition
Diabetes Mellitus, Type 1,Impaired Hypoglycemic Awareness,Severe Hypoglycemia
Age (in years)
18 - 65
Phase
Phase 1/Phase 2
Participants needed
17
Est. Completion Date
Jan 31, 2028
Treatment type
Interventional
Sponsor
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov identifier
NCT04786262
Study number
VX20-880-101
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