teplizumab for Type 1 Diabetes

Phase-Based Progress Estimates
Clinical Site, Aurora, COType 1 Diabetesteplizumab - Biological
Any Age
All Sexes
What conditions do you have?

Study Summary

This trial is for people who have developed type 1 diabetes after taking part in another trial testing a different diabetes treatment. The people in this trial will receive teplizumab, which may help to prevent or delay the onset of type 1 diabetes.

Eligible Conditions
  • Type 1 Diabetes

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: 78 weeks

78 weeks
Body Weight Changes
Clinical Parameter 1 of Diabetes Management
Clinical Parameter 2 of Diabetes Management
Clinical Parameter 3 of Diabetes Management
Immunogenicity of Teplizumab
Loss of C-peptide Produced by Pancreatic Beta Cells in Individuals with Recent Diagnosis of type 1 diabetes
Pharmacokinetics of Teplizumab
Therapeutic procedure

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

Teplizumab treated
1 of 1

Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: teplizumab · No Placebo Group · Phase 2

Teplizumab treated
Experimental Group · 1 Intervention: teplizumab · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 78 weeks

Who is running the clinical trial?

Provention Bio, Inc.Lead Sponsor
9 Previous Clinical Trials
1,018 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have already participated in the TN-10 study before.

Who else is applying?

What state do they live in?
How old are they?
18 - 65100.0%
What site did they apply to?
Clinical Site50.0%
Clinical site50.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
Why did patients apply to this trial?
  • "My son was diagnosed on the 14th of February 2022. My heart breaks for him every day. If there is any hope, once safe, I owe it to him to do all I can to get him the hrlp"

Frequently Asked Questions

Could you please tell us how many different places are coordinating this research?

"To reduce inconvenience for participants, this clinical trial has 5 different enrolment sites. These are located in Nashville, Gainesville and New Haven as well as other places." - Anonymous Online Contributor

Unverified Answer

How many people have been selected to participate in this research project?

"Yes, this is an ongoing study that is actively recruiting patients. The trial was established on March 2nd, 2020 and the most recent update was on September 27th, 2022. They are looking for 30 individuals to participate at 5 different sites." - Anonymous Online Contributor

Unverified Answer

Is this the first time that teplizumab has been used in a clinical trial?

"Teplizumab was first studied in 2019 at CHRU de Besancon-Hopital Jean Minjoz-(Site 511). So far, there have been six completed studies. There are presently two live studies being conducted, with a large number of these studies taking place in Nashville, Tennessee." - Anonymous Online Contributor

Unverified Answer

When might teplizumab be available to the general public?

"While there is some data suggesting teplizumab is safe, as this is only a Phase 2 trial, no efficacy has been proven yet. Therefore, it receives a score of 2." - Anonymous Online Contributor

Unverified Answer

To your knowledge, is this a groundbreaking study?

"There are 66 cities and 9 countries with active teplizumab clinical trials. The first study was conducted in 2019 by Provention Bio, Inc. This initial trial had 300 patients and completed its Phase 3 drug approval stage. In the 2 years since 2019, 6 more trials have been completed." - Anonymous Online Contributor

Unverified Answer

Are we still looking for volunteers to participate in this research?

"If you're interested, this trial could use your help. According to the latest update on clinicaltrials.gov (September 27th, 2020), the study is still looking for willing participants." - 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.