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
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 - February 2030
Study type
Interventional
Intervention/Treatment
Biological : VX-880
Estimated enrollment
37
Interested in this trial?
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.
Location
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