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

Recruiting

Phase 1, Phase 2

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.

ClinicalTrials.gov Identifier

NCT04786262

Eligibility criteria

Sex

Age

18 Years - 65 Years

Phase

1, 2

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 details

Condition

Diabetes Mellitus, Type 1, Impaired Hypoglycemic Awareness, Severe Hypoglycemia

Study duration

March 2021 - February 2030

Study type

Interventional

Intervention/Treatment

BIOLOGICAL : VX-880

Estimated enrollment

Interested in this trial?

Learn More

About clinical trials

Volunteers who participate in clinical trials help make new medicines a reality. Clinical trials are carefully designed research studies in humans that evaluate the safety and efficacy of an investigational medicine.

If you’re interested in participating in a Vertex clinical trial, we encourage you to speak with your health care provider first about what’s involved and your eligibility.

See FAQS

Location

Search for the closest clinical trial from your location

Recruiting

City of Hope

Duarte California 91010 United States