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VX-880 for Type 1 Diabetes and Severe Hypoglycemia

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

Recruiting Phase 3 Interventional Study
Diabetes Mellitus, Type 1 Impaired Hypoglycemic Awareness Severe Hypoglycemia
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

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At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
52 (estimated)
Sponsor
Vertex Pharmaceuticals Incorporated · Industry
Who this trial is looking for

This trial is looking for people with Type 1 diabetes who experience severe low blood sugar. Participants will receive an infusion of VX-880 and will need to use a continuous glucose monitor during the study.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have had Type 1 diabetes for more than 5 years
  • I have had at least two severe hypoglycemia episodes in the last year
  • I have stable diabetes treatment
  • I have used a continuous glucose monitor for at least 3 months

You may not be able to join if

  • I have had a prior islet cell transplant
  • I have had an organ transplant
  • I have had cell therapy

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

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

Trial Locations

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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 b…
Contacts

Medical Information

617-341-6777

medicalinfo@vrtx.com

CONTACT

NCT ID: NCT04786262 Source: ClinicalTrials.gov