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

a study on Diabetes Diabetes Type 1 Impaired Hypoglycemic Awareness Hypoglycemia

Summary

Eligibility
for people ages 18-65 (full criteria)
Location
at UCSF
Dates
study started
completion around

Description

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.

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

Keywords

Diabetes Mellitus, Type 1, Impaired Hypoglycemic Awareness, Severe Hypoglycemia, Diabetes Mellitus, Type 1 Diabetes Mellitus, Hypoglycemia

Eligibility

You can join if…

Open to people ages 18-65

  • 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

You CAN'T join if...

-Prior islet cell transplant, organ transplant, or cell therapy

Other protocol defined Inclusion/Exclusion criteria may apply

Locations

  • University of California San Francisco accepting new patients
    San Francisco California 94143 United States
  • City of Hope accepting new patients
    Duarte California 91010 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Vertex Pharmaceuticals Incorporated
ID
NCT04786262
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 52 study participants
Last Updated