Vedolizumab for Type 1 Diabetes

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Benaroya Research Institute, Seattle, WAType 1 DiabetesVedolizumab - Drug
Eligibility
18 - 45
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test whether a drug called vedolizumab, used to treat Crohn's disease and ulcerative colitis, can also be used to treat type 1 diabetes. The trial will also test whether pretreating with another drug, etanercept, can enhance vedolizumab's effectiveness.

Eligible Conditions
  • Type 1 Diabetes

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Vedolizumab

Study Objectives

3 Primary · 4 Secondary · Reporting Duration: baseline dose to 10 weeks and baseline dose to 52 weeks

Week 52
Impact on insulin secretion determined by 2-hour MMTT stimulated AUC C-peptide 10 weeks after first vedolizumab dose and 52 weeks after randomization.
baseline to 52 weeks
Adverse events of etanercept treatment as a measure of safety and tolerability
Adverse events of vedolizumab treatment as a measure of safety and tolerability
Change in T1D antibody titers
Frequency and surface marker phenotype of other immune cells such as antigen specific CD4 and CD8 cells, memory and naive T and B cells
Frequency of myeloid DC1 cells
Frequency of α4β7+ T cells

Trial Safety

Safety Progress

1 of 3

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2
SRW Cel System
2
Ustekinumab
1
Vedolizumab

Side Effects for

Vedolizumab 300 mg
9%Viral infection
9%Paronychia
9%Crohn's disease
9%Gastrointestinal motility disorder
9%Colitis ulcerative
This histogram enumerates side effects from a completed 2019 Phase 4 trial (NCT02559713) in the Vedolizumab 300 mg ARM group. Side effects include: Viral infection with 9%, Paronychia with 9%, Crohn's disease with 9%, Gastrointestinal motility disorder with 9%, Colitis ulcerative with 9%.

Trial Design

2 Treatment Groups

Arm B
1 of 2
Arm A
1 of 2

Experimental Treatment

20 Total Participants · 2 Treatment Groups

Primary Treatment: Vedolizumab · No Placebo Group · Phase < 1

Arm B
Drug
Experimental Group · 1 Intervention: Vedolizumab · Intervention Types: Drug
Arm AExperimental Group · 2 Interventions: Etanercept, Vedolizumab · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etanercept
2005
Completed Phase 4
~4740
Vedolizumab
2009
Completed Phase 4
~10530

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline dose to 10 weeks and baseline dose to 52 weeks

Who is running the clinical trial?

University of California, San DiegoOTHER
1,037 Previous Clinical Trials
1,825,562 Total Patients Enrolled
Benaroya Research InstituteLead Sponsor
40 Previous Clinical Trials
9,136 Total Patients Enrolled

Eligibility Criteria

Age 18 - 45 · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You were diagnosed with type 1 diabetes within the last three years before the screening.

Who else is applying?

How old are they?
< 18100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
References

Frequently Asked Questions

What prerequisites must be met to join this research program?

"To be eligible for this clinical trial, individuals should have diabetes, suffer from an autoimmune disorder and fall within the age range of 18-45 years old. 20 participants will eventually take part in the research." - Anonymous Online Contributor

Unverified Answer

How many participants can the trial accommodate in total?

"Affirmative. Information published on clinicaltrials.gov attests to the fact that this medical study is currently recruiting participants, having been posted on August 1st 2022 and recently modified on July 21st 2022. The trial seeks 20 individuals from 2 separate sites for participation." - Anonymous Online Contributor

Unverified Answer

Does this experiment seek additional participants at present?

"Right. Data hosted on clinicaltrials.gov attests to the fact that this medical trial is actively recruiting patients, as it was first posted on August 1st 2022 and recently updated on July 21st of the same year. The research requires 20 participants from 2 different health institutions." - Anonymous Online Contributor

Unverified Answer

Is the age requirement for this medical experiment limited to adults over 40?

"This trial is only available to those aged 18-45. By contrast, there are 155 trials geared towards minors and 178 specifically for seniors." - Anonymous Online Contributor

Unverified Answer

What aims is this research endeavor attempting to attain?

"This clinical trial seeks to measure the impact of vedolizumab on insulin secretion using a 2-hour MMTT stimulated AUC C-peptide over baseline and 52 weeks. Secondary objectives are to evaluate changes in T1D antibody titers, frequency of myeloid DC1 cells, as well as antigen specific CD4 and CD8 cell phenotype data collected through flow cytometry or CyTOF with the AIM assay." - 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.

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