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

Sponsor
Vertex Pharmaceuticals Incorporated (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04786262
Collaborator
(none)
17
Enrollment
11
Locations
1
Arm
81.1
Anticipated Duration (Months)
1.5
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: VX-880
 Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
17 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Mar 29, 2021
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jan 1, 2028

Arms and Interventions

Arm Intervention/Treatment
Experimental: VX-880

Biological: VX-880
Infused into the hepatic portal vein.
Other Names:
  • Formerly known as STx-02

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [From VX-880 infusion to end of study (up to 5 years)]

    2. Proportion of Participants Free of Severe Hypoglycemic Events With Either a Glycosylated Hemoglobin (HbA1c) <7.0% or a ≥ 1% Reduction in HbA1c From Baseline [At 1 year after VX-880 infusion]

    Secondary Outcome Measures

    1. Proportion of Participants who are Insulin Independent [At 1 year after VX-880 infusion]

    2. Changes in Stimulated C-peptide [At 1 year after VX-880 infusion]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 City of Hope Duarte California United States 91010
    2 UHealth Diabetes Research Institute Miami Florida United States 33136
    3 Northwestern Organ Transplant Center Chicago Illinois United States 60611
    4 University of Chicago Chicago Illinois United States 60637
    5 Massachusetts General Hospital Boston Massachusetts United States 02114
    6 Hospital of the University of Pennsylvania Philadelphia Pennsylvania United States 19104
    7 University of Pittsburgh Medical Center Montefiore Pittsburgh Pennsylvania United States 15213
    8 VCU Medical Center, Richmond Richmond Virginia United States 23298
    9 University of Wisconsin Madison Wisconsin United States 53792
    10 McGill University Health Centre Montreal Canada
    11 Toronto General Hospital (TGH) Toronto Canada

    Sponsors and Collaborators

    • Vertex Pharmaceuticals Incorporated

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vertex Pharmaceuticals Incorporated
    ClinicalTrials.gov Identifier:
    NCT04786262
    Other Study ID Numbers:
    • VX20-880-101
    First Posted:
    Mar 8, 2021
    Last Update Posted:
    Aug 9, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 1
    Hypoglycemia

    Study Results

    No Results Posted as of Aug 9, 2022