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Protease Inhibitor

VX-264 for Type 1 Diabetes

Phase 1 & 2
Recruiting
Research Sponsored by Vertex Pharmaceuticals Incorporated
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline up to 24 months
Awards & highlights

Study Summary

This trial will study a new treatment for type 1 diabetes to see if it is safe, well-tolerated, and effective.

Who is the study for?
This trial is for people with Type 1 Diabetes who have been managing their condition for over 5 years and are on a stable treatment plan. Participants must be using continuous glucose monitoring (CGM) consistently for at least a month before the study starts and agree to use it throughout the trial. Those who've had an islet cell or organ transplant, or cell therapy cannot join.Check my eligibility
What is being tested?
The study tests VX-264's safety, how well participants can tolerate it, and its effectiveness in individuals with Type 1 Diabetes. The main goal is to see if this new intervention could potentially improve diabetes management.See study design
What are the potential side effects?
While specific side effects of VX-264 aren't listed here, common concerns in trials like this may include reactions at injection sites, low blood sugar events, potential allergic reactions, and other unforeseen responses related to immune system changes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part A and Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Part B and Part C: Change in Peak C-peptide during Mixed-Meal Tolerance Test (MMTT)
Secondary outcome measures
Part C: Change in Average Total Daily Insulin Dose
Part C: Change in HbA1c values
Part C: Change in peak C-peptide during MMTT
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: VX-264Experimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Vertex Pharmaceuticals IncorporatedLead Sponsor
243 Previous Clinical Trials
32,371 Total Patients Enrolled

Media Library

VX-264 (Protease Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05791201 — Phase 1 & 2
Type 1 Diabetes Research Study Groups: VX-264
Type 1 Diabetes Clinical Trial 2023: VX-264 Highlights & Side Effects. Trial Name: NCT05791201 — Phase 1 & 2
VX-264 (Protease Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05791201 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is an eligible candidate for participation in this medical experiment?

"In order to be eligible for this medical trial, individuals must have type 1 diabetes and fall within the age range of 18-65. There are currently 17 spots open in the study."

Answered by AI

Does this trial extend to elderly individuals in their eighties?

"Patients between the age of 18 and 65 may join this medical trial, while 222 trials are available for minors and 937 studies catered to those above retirement age."

Answered by AI

Are additional participants needed for this research endeavor?

"As per the information on clinicaltrials.gov, this medical trial is still enrolling participants and has been since May 16th 2023. The most recent update to the study was recorded as of May 29th 2023."

Answered by AI

What is the present participant count for this investigation?

"Affirmative. The clinicaltrials.gov dataset shows that this experiment is actively recruiting participants, with an initial posting date of 16th May 2023 and last update on 29th May 2023. 17 patients must be recruited from one medical centre for the trial to proceed."

Answered by AI

Who else is applying?

What site did they apply to?
UHealth Diabetes Research Institute
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I am having a hard time controlling and living with type one diabetes and still have hope for a cure for a healthier life.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Safety, Tolerability, and Efficacy Study of VX-264 in Participants With Type 1 Diabetes
2023. "A Safety, Tolerability, and Efficacy Study of VX-264 in Participants With Type 1 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05791201.
~11 spots leftby May 2026
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