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

Last updated: March 3, 2025
Sponsor: Vertex Pharmaceuticals Incorporated
Overall Status: Active - Recruiting

Phase

3

Condition

Hormone Deficiencies

Diabetes (Pediatric)

Diabetes Mellitus, Type 1

Treatment

VX-880

Clinical Study ID

NCT04786262
VX20-880-101
2022-002292-11
2024-513929-23-00
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • 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 toenrollment

  • Stable diabetic treatment

  • Consistent use of continuous glucose monitor (CGM) for at least 3 months 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: 52
Treatment Group(s): 1
Primary Treatment: VX-880
Phase: 3
Study Start date:
March 29, 2021
Estimated Completion Date:
June 30, 2030

Connect with a study center

  • University of Alberta, Edmonton

    Edmonton,
    Canada

    Active - Recruiting

  • McGill University Health Centre

    Montreal,
    Canada

    Active - Recruiting

  • Toronto General Hospital (TGH)

    Toronto,
    Canada

    Active - Recruiting

  • Vancouver General Hospital

    Vancouver,
    Canada

    Active - Recruiting

  • CHU Lille

    Lille,
    France

    Active - Recruiting

  • Centre de recherche en Biomédecine de Strasbourg

    Strasbourg,
    France

    Active - Recruiting

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg,
    France

    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

  • Oslo University Hospital

    Oslo,
    Norway

    Active - Recruiting

  • Hopiteaux Universitaires de Geneve

    Geneve,
    Switzerland

    Active - Recruiting

  • Churchill Hospital

    Headington, Oxford
    United Kingdom

    Active - Recruiting

  • Royal Infirmary of Edinburgh

    Edinburgh,
    United Kingdom

    Active - Recruiting

  • Cardiovascular, Metabolic Medicine and Sciences, King's College London

    London,
    United Kingdom

    Active - Recruiting

  • The Newcastle upon Tyne Hospitals NHS Foundation Trust

    Newcastle Upon Tyne,
    United Kingdom

    Active - Recruiting

  • City of Hope

    Duarte, California 91010
    United States

    Active - Recruiting

  • University of California San Francisco

    San Francisco, California 94143
    United States

    Active - Recruiting

  • UHealth Diabetes Research Institute

    Miami, Florida 33136
    United States

    Active - Recruiting

  • Northwestern Organ Transplant Center

    Chicago, Illinois 60611
    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

  • VCU Medical Center, Richmond

    Richmond, Virginia 23298
    United States

    Active - Recruiting

  • University of Wisconsin

    Madison, Wisconsin 53792
    United States

    Active - Recruiting

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