VX-880 for Type 1 Diabetes

Recruiting in Palo Alto (17 mi)

+25 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Vertex Pharmaceuticals Incorporated

Disqualifiers: Prior transplants, cell therapy, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial will test the safety and effectiveness of VX-880 infusion in people with Type 1 diabetes who have trouble sensing low blood sugar and experience severe low blood sugar episodes. The treatment aims to help manage their blood sugar levels better.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that you should have a stable diabetic treatment, which might mean you can continue your current regimen.

Research Team

Eligibility Criteria

This trial is for people with Type 1 diabetes who've had it for over 5 years and have trouble sensing when their blood sugar gets too low. They should have had at least two serious low blood sugar events in the past year and must be using a continuous glucose monitor (CGM) for three months before, and during, the study.

Inclusion Criteria

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

At least two episodes of documented severe hypoglycemia in the 12 months prior to enrollment

I have been using a CGM for 3 months and am willing to continue.

See 3 more

Exclusion Criteria

I have had an islet cell, organ transplant, or cell therapy before.

There may be other requirements to participate in the study that are not listed here.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive VX-880 infusion to evaluate safety, tolerability, and efficacy

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Treatment Details

Interventions

VX-880 (Stem Cell Therapy)

Trial OverviewThe trial is testing VX-880's safety and effectiveness. Participants will receive an infusion of VX-880 to see if it helps manage Type 1 diabetes, especially for those who often don't notice when their blood sugar drops dangerously low.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: VX-880Experimental Treatment1 Intervention