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
Who is this study for? Adult patients with type 1 diabetes
What treatments are being studied? VX-880
Status: Recruiting
Location: See all (29) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• 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
Locations
United States
California
City of Hope
RECRUITING
Duarte
University of California San Francisco
RECRUITING
San Francisco
Florida
UHealth Diabetes Research Institute
RECRUITING
Miami
Illinois
Northwestern Organ Transplant Center
COMPLETED
Chicago
University of Chicago
RECRUITING
Chicago
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Maryland
Johns Hopkins University
RECRUITING
Baltimore
Pennsylvania
Hospital of the University of Pennsylvania
RECRUITING
Philadelphia
University of Pittsburgh Medical Center Montefiore
RECRUITING
Pittsburgh
Texas
Baylor Scott and White Research Institute
RECRUITING
Dallas
Virginia
VCU Medical Center, Richmond
RECRUITING
Richmond
Wisconsin
University of Wisconsin
RECRUITING
Madison
Other Locations
Canada
University of Alberta, Edmonton
RECRUITING
Edmonton
McGill University Health Centre
RECRUITING
Montreal
Toronto General Hospital (TGH)
RECRUITING
Toronto
Vancouver General Hospital
RECRUITING
Vancouver
France
CHU Lille
RECRUITING
Lille
Centre de recherche en Biomédecine de Strasbourg
RECRUITING
Strasbourg
Germany
Dresden Center for Islet Transplantation
RECRUITING
Dresden
Italy
IRCCS Ospedale San Raffaele
RECRUITING
Milan
Netherlands
Leiden University
RECRUITING
Leiden
Norway
Oslo University Hospital
RECRUITING
Oslo
Saudi Arabia
King Abdullah International Medical Research Center (KAIMRC) - Riyadh - Endocrinology
RECRUITING
Riyadh
King Faisal Specialist Hospital & Research Centre - Riyadh - Endocrinology
RECRUITING
Riyadh
Switzerland
Hopiteaux Universitaires de Geneve
RECRUITING
Geneva
United Kingdom
Royal Infirmary of Edinburgh
RECRUITING
Edinburgh
Churchill Hospital
RECRUITING
Headington
Cardiovascular, Metabolic Medicine and Sciences, King's College London
RECRUITING
London
The Newcastle upon Tyne Hospitals NHS Foundation Trust
RECRUITING
Newcastle Upon Tyne
Contact Information
Primary
Medical Information
medicalinfo@vrtx.com
617-341-6777
Time Frame
Start Date: 2021-03-29
Estimated Completion Date: 2030-06-30
Participants
Target number of participants: 52
Treatments
Experimental: VX-880
Related Therapeutic Areas
Sponsors
Leads: Vertex Pharmaceuticals Incorporated