Home › Trials › NCT04786262

Evaluating VX-880 for Type 1 Diabetes with Severe Hypoglycemia

A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, and Efficacy of VX-880 in Subjects Who Have Type 1 Diabetes Mellitus With Impaired Hypoglycemic Awareness and Severe Hypoglycemia

Phase 3 Interventional Vertex Pharmaceuticals Incorporated · NCT04786262

This study is testing if a new treatment called VX-880 can help people with Type 1 diabetes who have trouble sensing low blood sugar and have had severe low blood sugar episodes.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment52 (estimated)
Ages18 Years to 65 Years
SexAll
SponsorVertex Pharmaceuticals Incorporated Industry-sponsored
Locations29 sites (Duarte, California and 28 other locations)
Trial IDNCT04786262 on ClinicalTrials.gov

What this trial studies

This study assesses the safety, tolerability, and efficacy of VX-880 infusion in individuals with Type 1 diabetes who experience impaired awareness of hypoglycemia and have a history of severe hypoglycemic episodes. Participants must have been insulin-dependent for over five years and have documented severe hypoglycemia within the past year. The study will involve the use of continuous glucose monitoring to track participants' glucose levels throughout the trial. The goal is to determine if VX-880 can improve the management of their diabetes and reduce the risk of severe hypoglycemia.

Who should consider this trial

Good fit: Ideal candidates are individuals with Type 1 diabetes for more than five years who have experienced at least two episodes of severe hypoglycemia in the past year.

Not a fit: Patients who have previously undergone islet cell or organ transplants, or those who have received cell therapy, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the safety and quality of life for patients with Type 1 diabetes who struggle with severe hypoglycemia.

How similar studies have performed: While there have been studies on various treatments for Type 1 diabetes, the specific approach of using VX-880 in this context is novel and has not been extensively tested.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Duarte, California and 28 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Diabetes Mellitus, Type 1Impaired Hypoglycemic AwarenessSevere Hypoglycemia
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.