At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- VX-880 (biological), VX-017 (biological)
- How long the study runs
- Study runs about 129 months (dates as stated)
- About the drug or intervention
- VX-880 — biological: Infused into the hepatic portal vein. · VX-017 — biological: Infused into the hepatic portal vein.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, run by Vertex Pharmaceuticals Incorporated, is looking at the safety, tolerability (how well people cope with it), and effectiveness of a treatment called VX-880 in people with type 1 diabetes. It focuses on people who have impaired awareness of low blood sugar (hypoglycaemia) and severe hypoglycaemia. Details such as how the treatment works and where the study takes place are not stated — ask the trial team.
Who can take part
- Have had type 1 diabetes and needed insulin for more than 5 years
- Have had at least two documented episodes of severe low blood sugar (severe hypoglycaemia) in the 12 months before joining
- Are on stable diabetes treatment
- Have used a continuous glucose monitor (CGM — a device that checks blood sugar constantly) for at least 3 months before screening, and are willing to keep using it during the study
Who may not be able to
- Have previously had an islet cell transplant, an organ transplant, or cell therapy
- Other inclusion and exclusion criteria may apply — ask the trial team
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team (participants must be willing to use a continuous glucose monitor for the whole study).
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years to 65 Years
- Who
- All
- Number of participants
- 57
- Started
- 2021-03-29
- Last checked
- 2026-08
Plain English Summary
What is this study?
- • Testing a new treatment for diabetes mellitus, type 1
- • Phase3 - 57 participants
- • This study will evaluate the safety, tolerability and efficacy of VX-880 infusion and VX-017 infusion in participants with type 1 diabetes (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia
Who can take part?
- • Ages 18 Years to 65 Years
- • Diagnosed with diabetes mellitus, type 1
Where?
- • Headington - Churchill Hospital
- • Edinburgh - Royal Infirmary of Edinburgh
- • London - Cardiovascular, Metabolic Medicine and Sciences, King's College London
- • Newcastle upon Tyne - The Newcastle upon Tyne Hospitals NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This study will evaluate the safety, tolerability and efficacy of VX-880 infusion and VX-017 infusion in participants with type 1 diabetes (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 65 Years
- Who can join: All genders
What the study is looking for
- ✓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...
Who cannot take part
- ✗Prior islet cell transplant, organ transplant, or cell therapy
- ✗Other protocol-defined Inclusion/Exclusion criteria may apply
See the full criteria
Where Is This Study? (4 UK sites)
Churchill Hospital
Headington, United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, 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
How to Get in Touch
Medical Information
Sponsor contactCONTACT