RECRUITING

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

Description

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.

Conditions

Diabetes Mellitus, Type 1Impaired Hypoglycemic AwarenessSevere Hypoglycemia
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Related Conditions:

Diabetes Mellitus, Type 1Impaired Hypoglycemic AwarenessSevere Hypoglycemia

Study Overview

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Study Details

Study overview

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.

A Phase 1/2/3 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

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

Condition
Diabetes Mellitus, Type 1
Intervention / Treatment

-

Contacts and Locations

Duarte

City of Hope, Duarte, California, United States, 91010

Miami

UHealth Diabetes Research Institute, Miami, Florida, United States, 33136

Chicago

Northwestern Organ Transplant Center, Chicago, Illinois, United States, 60611

Chicago

University of Chicago, Chicago, Illinois, United States, 60637

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Philadelphia

Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104

Pittsburgh

University of Pittsburgh Medical Center Montefiore, Pittsburgh, Pennsylvania, United States, 15213

Richmond

VCU Medical Center, Richmond, Richmond, Virginia, United States, 23298

Madison

University of Wisconsin, Madison, Wisconsin, United States, 53792

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.

For general information about clinical research, read Learn About Studies.

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

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Vertex Pharmaceuticals Incorporated,

Study Record Dates

2030-06