← Back to searchRecruitingRecruiting
A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes
NCT04786262 · Vertex Pharmaceuticals Incorporated
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
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
About this study
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 criteria
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
Study design
Enrollment target: 52 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2021-03-29
Estimated completion: 2030-06-30
Last updated: 2026-03-17
Interventions
Biological: VX-880
Primary outcomes
- • Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) (From VX-880 infusion to end of study (up to 5 years))
- • Parts B and C: Proportion of Participants who are Insulin Independent with Absence of Severe Hypoglycemic Events (SHEs) (1 year after achieving insulin independence)
Sponsor
Vertex Pharmaceuticals Incorporated · industry
Contacts & investigators
ContactMedical Information · contact · medicalinfo@vrtx.com · 617-341-6777
All locations (29)
City of HopeRecruiting
Duarte, California, United States
University of California San FranciscoRecruiting
San Francisco, California, United States
UHealth Diabetes Research InstituteRecruiting
Miami, Florida, United States
Northwestern Organ Transplant CenterCompleted
Chicago, Illinois, United States
University of ChicagoRecruiting
Chicago, Illinois, United States
Johns Hopkins UniversityRecruiting
Baltimore, Maryland, United States
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States
Hospital of the University of PennsylvaniaRecruiting
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center MontefioreRecruiting
Pittsburgh, Pennsylvania, United States
Baylor Scott and White Research InstituteRecruiting
Dallas, Texas, United States
VCU Medical Center, RichmondRecruiting
Richmond, Virginia, United States
University of WisconsinRecruiting
Madison, Wisconsin, United States
University of Alberta, EdmontonRecruiting
Edmonton, Canada
McGill University Health CentreRecruiting
Montreal, Canada
Toronto General Hospital (TGH)Recruiting
Toronto, Canada
Vancouver General HospitalRecruiting
Vancouver, Canada
CHU LilleRecruiting
Lille, France
Centre de recherche en Biomédecine de StrasbourgRecruiting
Strasbourg, France
Dresden Center for Islet TransplantationRecruiting
Dresden, Germany
IRCCS Ospedale San RaffaeleRecruiting
Milan, Italy
Leiden UniversityRecruiting
Leiden, Netherlands
Oslo University HospitalRecruiting
Oslo, Norway
King Abdullah International Medical Research Center (KAIMRC) - Riyadh - EndocrinologyRecruiting
Riyadh, Saudi Arabia
King Faisal Specialist Hospital & Research Centre - Riyadh - EndocrinologyRecruiting
Riyadh, Saudi Arabia
Hopiteaux Universitaires de GeneveRecruiting
Geneva, Switzerland
Churchill HospitalRecruiting
Headington, Oxford, United Kingdom
Royal Infirmary of EdinburghRecruiting
Edinburgh, United Kingdom
Cardiovascular, Metabolic Medicine and Sciences, King's College LondonRecruiting
London, United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation TrustRecruiting
Newcastle upon Tyne, United Kingdom