RightFit
RecruitingPhase 3

A Safety, Tolerability, and Efficacy Study of VX-880 and VX-017 in Participants With Type 1 Diabetes

A Master Protocol to Evaluate the Safety, Tolerability, and Efficacy of Islet Cell Replacement Therapies in Subjects Who Have Type 1 Diabetes Mellitus With Impaired Hypoglycemic Awareness and Severe Hypoglycemia: A Phase 1/2/3 Study of VX-880 and a Phase 1/2 Study of VX-017

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe VX-880 and VX-017 infusions are, how well people tolerate them, and how well they work. It is for people with type 1 diabetes who have severe low blood sugar and trouble noticing when their blood sugar is low.

This study will evaluate the safety, tolerability and efficacy of VX-880 infusion and VX-017 infusion in participants with type 1 diabetes (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have type 1 diabetes and have needed insulin for at least 5 years.
  • Have had at least 2 recorded episodes of severe low blood sugar in the 12 months before joining.
  • Have a stable diabetes treatment plan.
  • Have regularly used a continuous glucose monitor (CGM), a device that tracks blood sugar, for at least 3 months before screening and agree to use it throughout the study.

Who can't join

  • Have had an islet cell transplant (cells that make insulin), an organ transplant, or cell therapy (treatment using cells).
  • Other study rules may also affect who can join.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Key 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 Key Exclusion Criteria: -Prior islet cell transplant, organ transplant, or cell therapy Other protocol-defined Inclusion/Exclusion criteria may apply

Study sites (12)

CA

FL

IL

MA

MD

PA

TX

VA

WI