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

Last updated: December 5, 2024
Sponsor: Vertex Pharmaceuticals Incorporated
Overall Status: Active - Recruiting

Phase

1/2

Condition

Diabetes And Hypertension

Diabetes Prevention

Diabetes Mellitus Types I And Ii

Treatment

VX-264

Clinical Study ID

NCT05791201
VX22-264-101
2024-515583-32-00
2022-003318-35
  • Ages 18-65
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 beforeScreening and willingness to use CGM for the duration of the study

Exclusion

Key Exclusion Criteria:

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

Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 17
Treatment Group(s): 1
Primary Treatment: VX-264
Phase: 1/2
Study Start date:
May 16, 2023
Estimated Completion Date:
May 31, 2026

Connect with a study center

  • University of Alberta, Edmonton

    Edmonton,
    Canada

    Active - Recruiting

  • Montreal Clinical Research Institute

    Montreal,
    Canada

    Active - Recruiting

  • Toronto General Hospital (TGH)

    Toronto,
    Canada

    Active - Recruiting

  • Vancouver General Hospital

    Vancouver,
    Canada

    Active - Recruiting

  • Dresden Center for Islet Transplantation

    Dresden,
    Germany

    Active - Recruiting

  • IRCCS Ospedale San Raffaele

    Milan,
    Italy

    Active - Recruiting

  • Leiden University

    Leiden,
    Netherlands

    Active - Recruiting

  • Hopiteaux Universitaires de Geneve

    Geneve,
    Switzerland

    Active - Recruiting

  • Churchill Hospital

    Headington,
    United Kingdom

    Active - Recruiting

  • Royal Victoria Infirmary

    Newcastle Upon Tyne,
    United Kingdom

    Active - Recruiting

  • UHealth Diabetes Research Institute

    Miami, Florida 33136
    United States

    Active - Recruiting

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • University of Pittsburgh Medical Center Montefiore

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

  • University of Wisconsin

    Madison, Wisconsin 53792
    United States

    Active - Recruiting

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