A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes

General Information

Summary A Phase 1/2 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.
Description 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.
Clinical trials phase Phases 1/2
Start date (estimated) 2021-03-29
End date (estimated) 2028-01-31
Clinical feature
Label type 1 diabetes mellitus
Link http://purl.obolibrary.org/obo/DOID_9744
Description A diabetes mellitus that is characterized by destruction of pancreatic beta cells resulting in absent or extremely low insulin production.; Xref MGI. OMIM mapping confirmed by DO. [SN].

Administrative Information

NCT number NCT04786262
ICTRP weblink https://trialsearch.who.int/Trial2.aspx?TrialID=NCT04786262
EudraCT number 2022-002292-11
Other study identifiers
Name VX20-880-101
Source weblink https://clinicaltrials.gov/ct2/show/NCT04786262
Regulatory body approval
Name Food and Drug Administration (FDA)
United States
Public contact
Email medicalinfo@vrtx.com
Public email medicalinfo@vrtx.com
Last name Medical Information
Phone +1 617-341-6777
United States
Sponsors Vertex Pharmaceuticals Incorporated


Which differentiated cell type is used
Label progenitor cell of endocrine pancreas
Link http://purl.obolibrary.org/obo/CL_0002351
Description A progenitor cell that is able to differentiate into the pancreas alpha, beta and delta endocrine cells. This cell type expresses neurogenin-3 and Isl-1.


Recruitment Status Recruiting
Estimated number of participants 17