A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorVertex Pharmaceuticals Incorporated
About this trial
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
Qualifiers
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
Disqualifiers
None
Trial design
Treatments tested in this trial
- VX-880
Treatment groups
52 Participants
are divided into 1 treatment groupLocations
29Canada
University of Alberta, Edmonton Edmonton Canada
McGill University Health Centre Montreal Canada
Toronto General Hospital (TGH) Toronto Canada
Vancouver General Hospital Vancouver Canada
Sponsors and collaborators
Vertex Pharmaceuticals Incorporated
Lead sponsor
Source ClinicalTrials.gov