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NCT05791201 | RECRUITING | Type 1 Diabetes

A Safety, Tolerability, and Efficacy Study of VX-264 in Participants With Type 1 Diabetes
Sponsor:

Vertex Pharmaceuticals Incorporated

Brief Summary:

The purpose of the study is to evaluate the safety, tolerability, and efficacy of VX-264 in participants with type 1 diabetes (T1D).

Condition or disease

Type 1 Diabetes

Intervention/treatment

VX-264

Phase

PHASE1

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 17 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of VX-264 in Subjects With Type 1 Diabetes Mellitus
Actual Study Start Date : 2023-05-16
Estimated Primary Completion Date : 2026-05
Estimated Study Completion Date : 2026-05

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Key Inclusion Criteria
  • * Clinical history of T1D with greater than or equal to (\>=) 5 years duration
  • * Participant is on a stable diabetic treatment
  • * Consistent use of continuous glucose monitoring (CGM) for at least 4 weeks before Screening and willingness to use CGM for the duration of the study
  • Key Exclusion Criteria
    • * Prior islet cell transplant, organ transplant, or cell therapy
    • Other protocol defined Inclusion/Exclusion criteria may apply.
A Safety, Tolerability, and Efficacy Study of VX-264 in Participants With Type 1 Diabetes

Location Details

NCT05791201

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Florida

UHealth Diabetes Research Institute

Miami, florida, United States, 33136

RECRUITING

United States, Illinois

University of Chicago

Chicago, Illinois, United States, 60637

RECRUITING

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

RECRUITING

United States, Pennsylvania

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

RECRUITING

United States, Pennsylvania

University of Pittsburgh Medical Center Montefiore

Pittsburgh, Pennsylvania, United States, 15213

RECRUITING

United States, Wisconsin

University of Wisconsin

Madison, Wisconsin, United States, 53792

RECRUITING

Canada,

University of Alberta, Edmonton

Edmonton, Canada,

RECRUITING

Canada,

Montreal Clinical Research Institute

Montreal, Canada,

RECRUITING

Canada,

Toronto General Hospital (TGH)

Toronto, Canada,

RECRUITING

Canada,

Vancouver General Hospital

Vancouver, Canada,

RECRUITING

Germany,

Dresden Center for Islet Transplantation

Dresden, Germany,

RECRUITING

Italy,

IRCCS San Raffaele Hospital

Milan, Italy,

RECRUITING

Netherlands,

Leiden University

Leiden, Netherlands,

RECRUITING

Switzerland,

Geneva University Hospitals

Geneva, Switzerland,

RECRUITING

United Kingdom,

Churchill Hospital

Headington, United Kingdom,

RECRUITING

United Kingdom,

Royal Victoria Infirmary

Newcastle Upon Tyne, United Kingdom,