Phase 3 Type 1 Diabetes Trial, Recruiting (NCT04786262)

Phase 3 Type 1 Diabetes Trial, Recruiting NCT04786262 Sponsor: Vertex Pharmaceuticals Incorporated Condition: Type 1 Diabetes

Printed from Voxsanity (voxsanity.com.au) — NCT04786262 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

Back to Type 1 Diabetes

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

People who have a clinical history of Type 1 Diabetes (T1D) and have been dependent on insulin for more than 5 years
People who have had at least two serious low blood sugar episodes (severe hypoglycemia) that were recorded in the 12 months before joining the trial
People whose diabetes treatment has been stable (not significantly changed recently)
People who have been consistently using a continuous glucose monitor (CGM) — a device that tracks blood sugar levels automatically — for at least 3 months before the screening stage, and who are willing to continue using one throughout the trial

Who may not be able to join:

People who have previously had an islet cell transplant, any organ transplant, or a cell-based therapy
People who do not meet other criteria set out in the full study protocol (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.

Last synced 20 July 2026

Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 617-341-6777

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Voxsanity

Clinical trials and treatments, explained plainly · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I am writing to enquire about the following clinical trial which may be relevant to my care:

Trial: NCT04786262

Sponsor: Vertex Pharmaceuticals Incorporated

Phase: Phase 3

Status: Recruiting

Condition: Type 1 Diabetes

Trial contact: 617-341-6777

More information: https://clinicaltrials.gov/study/NCT04786262

Eligibility summary (AI generated)

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

People who have a clinical history of Type 1 Diabetes (T1D) and have been dependent on insulin for more than 5 years
People who have had at least two serious low blood sugar episodes (severe hypoglycemia) that were recorded in the 12 months before joining the trial
People whose diabetes treatment has been stable (not significantly changed recently)
People who have been consistently using a continuous glucose monitor (CGM) — a device that tracks blood sugar levels automatically — for at least 3 months before the screening stage, and who are willing to continue using one throughout the trial

Who may not be able to join:

People who have previously had an islet cell transplant, any organ transplant, or a cell-based therapy
People who do not meet other criteria set out in the full study protocol (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.

This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 20 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.

Trial details

Status

Recruiting

Phase

Phase 3

Sponsor

Vertex Pharmaceuticals Incorporated

Registry

ClinicalTrials.gov

Start date

29 March 2021

Est. completion

30 June 2027

Where this trial is recruiting

🇨🇦 Canada 🇫🇷 France 🇩🇪 Germany 🇮🇹 Italy 🇳🇱 Netherlands 🇳🇴 Norway 🇸🇦 Saudi Arabia 🇨🇭 Switzerland 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs); Parts B and C: Proportion of Participants who are Insulin Independent with Absence of Severe Hypoglycemic Events (SHEs)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov