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

NCT04786262

RecruitingPhase 3

Sponsor: Vertex Pharmaceuticals Incorporated

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

Interventions: VX-880

Countries: United States, Canada, France, Germany, Italy, Netherlands, Norway, Saudi Arabia

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (29)
  • Duarte, California, United States
  • San Francisco, California, United States
  • Miami, Florida, United States
  • Chicago, Illinois, United States
  • Chicago, Illinois, United States
  • Baltimore, Maryland, United States
  • Boston, Massachusetts, United States
  • Philadelphia, Pennsylvania, United States
  • Pittsburgh, Pennsylvania, United States
  • Dallas, Texas, United States
  • Richmond, Virginia, United States
  • Madison, Wisconsin, United States
  • Edmonton, Canada
  • Montreal, Canada
  • Toronto, Canada
  • Vancouver, Canada
  • Lille, France
  • Strasbourg, France
  • Dresden, Germany
  • Milan, Italy
  • Leiden, Netherlands
  • Oslo, Norway
  • Riyadh, Saudi Arabia
  • Riyadh, Saudi Arabia
  • Geneva, Switzerland
  • Headington, Oxford, United Kingdom
  • Edinburgh, United Kingdom
  • London, United Kingdom
  • Newcastle upon Tyne, United Kingdom