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)
Country
United States
Sponsors Vertex Pharmaceuticals Incorporated

Cells

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

Recruitment Status Recruiting
Estimated number of participants 17