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

Purpose

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 1
  • Impaired Hypoglycemic Awareness
  • Severe Hypoglycemia

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 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

Exclusion Criteria

  • Prior islet cell transplant, organ transplant, or cell therapy Other protocol defined Inclusion/Exclusion criteria may apply

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
VX-880
  • Biological: VX-880
    Infused into the hepatic portal vein.
    Other names:
    • Formerly known as STx-02

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114

More Details

Status
Recruiting
Sponsor
Vertex Pharmaceuticals Incorporated

Study Contact

Medical Information
617-341-6777
medicalinfo@vrtx.com