A Safety, Tolerability, and Efficacy Study of VX-880 and VX-017 in Participants With Type 1 Diabetes
Recruiting · NCT04786262 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
VX-017VX-880
What this trial is about
This study will evaluate the safety, tolerability and efficacy of VX-880 infusion and VX-017 infusion in participants with type 1 diabetes (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
- ther protocol-defined Inclusion/Exclusion criteria may apply
Where it is running
29 locations listed across 9 US states.
- City of Hope - Duarte, California, United States
- University of California San Francisco - San Francisco, California, United States
- UHealth Diabetes Research Institute - Miami, Florida, United States
- Northwestern Organ Transplant Center - Chicago, Illinois, United States
- University of Chicago - Chicago, Illinois, United States
- Johns Hopkins University - Baltimore, Maryland, United States
- Massachusetts General Hospital - Boston, Massachusetts, United States
- Hospital of the University of Pennsylvania - Philadelphia, Pennsylvania, United States
- University of Pittsburgh Medical Center Montefiore - Pittsburgh, Pennsylvania, United States
- Baylor Scott and White Research Institute - Dallas, Texas, United States
- VCU Medical Center, Richmond - Richmond, Virginia, United States
- University of Wisconsin - Madison, Wisconsin, United States
- Dresden Center for Islet Transplantation - Dresden, Germany
- Royal Infirmary of Edinburgh - Edinburgh, United Kingdom
- University of Alberta, Edmonton - Edmonton, Canada
- Hopiteaux Universitaires de Geneve - Geneva, Switzerland
- Leiden University - Leiden, Netherlands
- CHU Lille - Lille, France
- Cardiovascular, Metabolic Medicine and Sciences, King's College London - London, United Kingdom
- IRCCS Ospedale San Raffaele - Milan, Italy
- McGill University Health Centre - Montreal, Canada
- The Newcastle upon Tyne Hospitals NHS Foundation Trust - Newcastle upon Tyne, United Kingdom
- Oslo University Hospital - Oslo, Norway
- King Abdullah International Medical Research Center (KAIMRC) - Riyadh - Endocrinology - Riyadh, Saudi Arabia
- King Faisal Specialist Hospital & Research Centre - Riyadh - Endocrinology - Riyadh, Saudi Arabia
- Centre de recherche en Biomédecine de Strasbourg - Strasbourg, France
- Toronto General Hospital (TGH) - Toronto, Canada
- Vancouver General Hospital - Vancouver, Canada
- Churchill Hospital - Headington, Oxford, United Kingdom