VX-880 for Type 1 Diabetes

University of Alberta, Edmonton, Edmonton, Canada
Type 1 Diabetes+2 More ConditionsVX-880 - Biological
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study if VX-880 is safe and effective in people with Type 1 diabetes who have impaired awareness of low blood sugar and have had severe hypoglycemia.

Eligible Conditions
  • Type 1 Diabetes
  • Low Blood Sugar
  • Hypoglycemia Unawareness Syndrome

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1 & 2

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: From VX-880 infusion to end of study (up to 5 years)

Year 1
Changes in Stimulated C-peptide
Proportion of Participants Free of Severe Hypoglycemic Events With Either a Glycosylated Hemoglobin (HbA1c) <7.0% or a ≥ 1% Reduction in HbA1c From Baseline
Proportion of Participants who are Insulin Independent
Year 5
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Trial Safety

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

VX-880
1 of 1

Experimental Treatment

17 Total Participants · 1 Treatment Group

Primary Treatment: VX-880 · No Placebo Group · Phase 1 & 2

VX-880
Biological
Experimental Group · 1 Intervention: VX-880 · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from vx-880 infusion to end of study (up to 5 years)

Who is running the clinical trial?

Vertex Pharmaceuticals IncorporatedLead Sponsor
230 Previous Clinical Trials
31,194 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your diabetes is well controlled with your current treatment.

Who else is applying?

What state do they live in?
New York33.3%
North Carolina16.7%
Pennsylvania16.7%
Other33.3%
How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria50.0%
Met criteria50.0%
What site did they apply to?
University of Chicago25.0%
Hospital of the University of Pennsylvania25.0%
University of Pittsburgh Medical Center Montefiore25.0%
Other25.0%
Why did patients apply to this trial?
  • "I want to help because I hate having diabetes"
How many prior treatments have patients received?
3+100.0%

How responsive is this trial?

Typically responds via
Phone Call50.0%
Email50.0%
Most responsive sites:
  1. VCU Medical Center, Richmond: < 24 hours
Average response time
  • < 1 Day

Frequently Asked Questions

In how many different medical clinics is this research study being conducted today?

"So far, 11 locations have recruited patients for this trial. For example, there are participants from Massachusetts General Hospital in Boston, University of Wisconsin in Madison, and Hospital of the University of Pennsylvania in Philadelphia." - Anonymous Online Contributor

Unverified Answer

Can people with the specified condition still sign up for this trial?

"Yes, the clinical trial is still recruiting patients. According to information on clinicaltrials.gov, the trial was first posted on 3/29/2021 and was last edited on 8/8/2022. So far, 17 participants have been recruited from 11 different sites." - Anonymous Online Contributor

Unverified Answer

Does this study have an age requirement?

"The current enrolment phase for this clinical trial includes people aged 18-65." - Anonymous Online Contributor

Unverified Answer

How many participants are being recruited for this research?

"As specified by the sponsor, Vertex Pharmaceuticals Incorporated, a total of 17 patients that meet this trial's inclusion criteria are required in order to run the study from various locations - such as Massachusetts General Hospital in Boston, Wisconsin and University of Wisconsin in Madison, Pennsylvania." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.