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

October 30, 2023 updated by: Vertex Pharmaceuticals Incorporated

A Phase 1/2 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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

17

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
      • Edmonton, Canada
        • Recruiting
        • University of Alberta, Edmonton
      • Montreal, Canada
        • Recruiting
        • McGill University Health Centre
      • Toronto, Canada
        • Recruiting
        • Toronto General Hospital (TGH)
      • Vancouver, Canada
        • Recruiting
        • Vancouver General Hospital
  • France
      • Lille, France
        • Recruiting
        • CHU Lille
      • Strasbourg, France
        • Recruiting
        • Hopitaux Universitaires de Strasbourg
  • Germany
      • Dresden, Germany
        • Recruiting
        • Dresden Center for Islet Transplantation
  • Italy
      • Milan, Italy
        • Recruiting
        • IRCCS Ospedale San Raffaele
  • Netherlands
      • Leiden, Netherlands
        • Recruiting
        • Leiden University
  • Norway
      • Oslo, Norway
        • Recruiting
        • Oslo University Hospital
  • Switzerland
      • Geneve, Switzerland
        • Recruiting
        • Hopiteaux Universitaires de Geneve
  • United Kingdom
      • Newcastle Upon Tyne, United Kingdom
        • Recruiting
        • The Newcastle Upon Tyne Hospitals NHS Foundation Trust
    • Oxford
      • Headington, Oxford, United Kingdom
        • Recruiting
        • Churchill Hospital
  • United States
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • UHealth Diabetes Research Institute
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern Organ Transplant Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Hospital of the University of Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • University of Pittsburgh Medical Center Montefiore
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • VCU Medical Center, Richmond
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Clinical history of T1D with > 5 years of duration
  • 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

Key Exclusion Criteria:

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

Other protocol defined Inclusion/Exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VX-880
Biological: VX-880
Infused into the hepatic portal vein.
Other Names:
  • Formerly known as STx-02

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: From VX-880 infusion to end of study (up to 5 years)
From VX-880 infusion to end of study (up to 5 years)
Proportion of Participants Free of Severe Hypoglycemic Events With Either a Glycosylated Hemoglobin (HbA1c) <7.0% or a ≥ 1% Reduction in HbA1c From Baseline
Time Frame: At 1 year after VX-880 infusion
At 1 year after VX-880 infusion

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of Participants who are Insulin Independent
Time Frame: At 1 year after VX-880 infusion
At 1 year after VX-880 infusion
Changes in Stimulated C-peptide
Time Frame: At 1 year after VX-880 infusion
At 1 year after VX-880 infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vertex Pharmaceuticals Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2021

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

March 3, 2021

First Submitted That Met QC Criteria

March 3, 2021

First Posted (Actual)

March 8, 2021

Study Record Updates

Last Update Posted (Actual)

October 31, 2023

Last Update Submitted That Met QC Criteria

October 30, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VX20-880-101
  • 2022-002292-11 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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