A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, and Efficacy of VX-880 in Subjects Who Have Type 1 Diabetes Mellitus With Impaired Hypoglycemic Awareness and Severe Hypoglycemia
Vertex Pharmaceuticals Incorporated
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 range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- BiologicalVX-880
Infused into the hepatic portal vein.
Locations (29)
- City of HopeDuarte, California
- University of California San FranciscoSan Francisco, California
- UHealth Diabetes Research InstituteMiami, Florida
- Northwestern Organ Transplant CenterChicago, Illinois
- University of ChicagoChicago, Illinois
- Johns Hopkins UniversityBaltimore, Maryland