A Safety, Tolerability, and Efficacy Study of VX-880 and VX-017 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
study ends around
Principal Investigator
by Charles Gerard Rickert (ucsf)
Headshot of Charles Gerard Rickert
Charles Gerard Rickert

Description

Summary

This study will evaluate the safety, tolerability and efficacy of VX-880 infusion and VX-017 infusion in participants with type 1 diabetes (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia.

Official Title

A Master Protocol to Evaluate the Safety, Tolerability, and Efficacy of Islet Cell Replacement Therapies in Subjects Who Have Type 1 Diabetes Mellitus With Impaired Hypoglycemic Awareness and Severe Hypoglycemia: A Phase 1/2/3 Study of VX-880 and a Phase 1/2 Study of VX-017

Keywords

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

Lead Scientist at University of California Health

  • Charles Gerard Rickert (ucsf)
    Since 2014, I have been a general surgery resident at the Massachusetts General Hospital, in Boston, MA. In addition to working in all areas of general surgery, I have been particularly engaged in efforts to connect to the community and decrease the impact of prejudice and bias in the care for surgery patients.

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 57 study participants
Last Updated
Contact us about this trial