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

Phase 3

Recruiting

• Conditions: Diabetes Mellitus, Type 1; Severe Hypoglycemia; Impaired Hypoglycemic Awareness
• Interventions: Biological: VX-880

• Registration Number: NCT04786262
• Lead Sponsor: Vertex Pharmaceuticals Incorporated

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Related News

Study Timeline

• Study First Submitted: 2021-03-03
• Study First Submitted QC: 2021-03-03
• Study First Posted: 2021-03-08
• Study Start: 2021-03-29
• Status Verified: 2024-06
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-20
• Primary Completion: 2027-06
• Study Completion: 2030-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 52

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

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Exclusion Criteria

• Prior islet cell transplant, organ transplant, or cell therapy

Other protocol defined Inclusion/Exclusion criteria may apply

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VX-880	VX-880	-

Primary Outcome Measures

Name	Time	Method
Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs)	From VX-880 infusion to end of study (up to 5 years)
Parts B and C: Proportion of Participants who are Insulin Independent with Absence of Severe Hypoglycemic Events (SHEs)	1 year after achieving insulin independence

Secondary Outcome Measures

Name	Time	Method
Parts B and C: Proportion of Participants who are Insulin Independent	At 1 year after VX-880 infusion
Parts B and C: Proportion of Participants Free from SHEs with a Glycosylated Hemoglobin (HbA1c) less than (<) 7.0%	At 1 year after VX-880 infusion
Parts B and C: Change From Baseline in Glycosylated Hemoglobin (HbA1c)	At 1 year after VX-880 infusion
Parts B and C: Proportion of Participants Who Maintain Insulin Independence for at least 1 year	From VX-880 infusion to end of study (up to 5 years)
Parts B and C: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs)	From Signing of informed consent to end of study (up to 5 years)

Trial Locations

Locations (23)

Northwestern Organ Transplant Center; 🇺🇸 Chicago, Illinois, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center Montefiore; 🇺🇸 Pittsburgh, Pennsylvania, United States

UHealth Diabetes Research Institute; 🇺🇸 Miami, Florida, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Oslo University Hospital; 🇳🇴 Oslo, Norway

Leiden University; 🇳🇱 Leiden, Netherlands

Hopiteaux Universitaires de Geneve; 🇨🇭 Geneve, Switzerland

City of Hope; 🇺🇸 Duarte, California, United States

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States

VCU Medical Center, Richmond; 🇺🇸 Richmond, Virginia, United States

McGill University Health Centre; 🇨🇦 Montreal, Canada

Toronto General Hospital (TGH); 🇨🇦 Toronto, Canada

University of Alberta, Edmonton; 🇨🇦 Edmonton, Canada

Centre de recherche en Biomédecine de Strasbourg; 🇫🇷 Strasbourg, France

Vancouver General Hospital; 🇨🇦 Vancouver, Canada

Dresden Center for Islet Transplantation; 🇩🇪 Dresden, Germany

CHU Lille; 🇫🇷 Lille, France

IRCCS Ospedale San Raffaele; 🇮🇹 Milan, Italy

Churchill Hospital; 🇬🇧 Headington, Oxford, United Kingdom

Cardiovascular, Metabolic Medicine and Sciences, King's College London; 🇬🇧 London, United Kingdom

The Newcastle upon Tyne Hospitals NHS Foundation Trust; 🇬🇧 Newcastle Upon Tyne, United Kingdom