Menu
Recruiting NCT04786262

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

Phase III Interventional Diabetes Mellitus, Type 1 Impaired Hypoglycemic Awareness Severe Hypoglycemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: VX-880.
Who it may be relevant to
Registry conditions: Diabetes Mellitus, Type 1, Impaired Hypoglycemic Awareness, Severe Hypoglycemia. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Canada, France, Germany, Italy +5
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Biological VX-880
    Infused into the hepatic portal vein.

Primary outcome measures

  • Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) [Time frame: 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) [Time frame: 1 year after achieving insulin independence]
Secondary outcome measures (5)
  • Parts B and C: Proportion of Participants who are Insulin Independent [Time frame: 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% [Time frame: At 1 year after VX-880 infusion]
  • Parts B and C: Change From Baseline in Glycosylated Hemoglobin (HbA1c) [Time frame: At 1 year after VX-880 infusion]
  • Parts B and C: Proportion of Participants Who Maintain Insulin Independence for at least 1 year [Time frame: 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) [Time frame: From Signing of informed consent to end of study (up to 5 years)]

Eligibility criteria

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

Exclusion criteria

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

Other protocol defined Inclusion/Exclusion criteria may apply

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 12 centers
  • City of Hope — Duarte
  • University of California San Francisco — San Francisco
  • UHealth Diabetes Research Institute — Miami
  • Northwestern Organ Transplant Center — Chicago
  • University of Chicago — Chicago
  • Johns Hopkins University — Baltimore
  • Massachusetts General Hospital — Boston
  • Hospital of the University of Pennsylvania — Philadelphia
  • … and 4 more centers
Canada · 4 centers
  • University of Alberta, Edmonton — Edmonton
  • McGill University Health Centre — Montreal
  • Toronto General Hospital (TGH) — Toronto
  • Vancouver General Hospital — Vancouver
United Kingdom · 4 centers
  • Churchill Hospital — Headington
  • Royal Infirmary of Edinburgh — Edinburgh
  • Cardiovascular, Metabolic Medicine and Sciences, King's College London — London
  • The Newcastle upon Tyne Hospitals NHS Foundation Trust — Newcastle upon Tyne
France · 2 centers
  • CHU Lille — Lille
  • Centre de recherche en Biomédecine de Strasbourg — Strasbourg
Saudi Arabia · 2 centers
  • King Abdullah International Medical Research Center (KAIMRC) - Riyadh - Endocrinology — Riyadh
  • King Faisal Specialist Hospital & Research Centre - Riyadh - Endocrinology — Riyadh
Germany · 1 center
  • Dresden Center for Islet Transplantation — Dresden
Italy · 1 center
  • IRCCS Ospedale San Raffaele — Milan
Netherlands · 1 center
  • Leiden University — Leiden
Norway · 1 center
  • Oslo University Hospital — Oslo
Switzerland · 1 center
  • Hopiteaux Universitaires de Geneve — Geneva

Publications

  • Reichman TW, Markmann JF, Odorico J, Witkowski P, Fung JJ, Wijkstrom M, Kandeel F, de Koning EJP, Peters AL, Mathieu C, Kean LS, Bruinsma BG, Wang C, Mascia M, Sanna B, Marigowda G, Pagliuca F, Melton D, Ricordi C, Rickels MR; VX-880-101 FORWARD Study Group. Stem Cell-Derived, Fully Differentiated Islets for Type 1 Diabetes. N Engl J Med. 2025 Sep 4;393(9):858-868. doi: 10.1056/NEJMoa2506549. Epub PMID 40544428

Identifiers

NCT: NCT04786262 · VX20-880-101 · 2024-513929-23-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗