The trial is taking place at:
U

University of Wisconsin | Department of Ophthalmology and Visual Sciences - Clinical Eye Research Unit

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

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Vertex Pharmaceuticals

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

Diabetes Mellitus, Type 1
Impaired Hypoglycemic Awareness
Severe Hypoglycemia

Treatments

Biological: VX-880

Study type

Interventional

Funder types

Industry

Identifiers

NCT04786262
2022-002292-11 (EudraCT Number)
VX20-880-101

Details and patient eligibility

About

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.

Enrollment

17 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

17 participants in 1 patient group

VX-880
Experimental group
Treatment:
Biological: VX-880

Trial contacts and locations

22

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Central trial contact

Medical Information

Data sourced from clinicaltrials.gov

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