Active not recruitingOBSERVATIONAL

Recent-Onset Type 1 Diabetes Extension Study Evaluating the Long-Term Safety of Teplizumab (PROTECT Extension)

This study is an extension of a previous one called PROTECT. It aims to gather more information on the long-term safety of a treatment called teplizumab. Teplizumab is a medicine designed for children and teenagers aged 8 to 17 who have recently been diagnosed with Type 1 diabetes. In the original PROTECT study, some participants received teplizumab and others received a dummy treatment (placebo). This new extension study will follow those participants for an additional 42 months (that's three and a half years). No new study medication will be given during this extension. The main goal is to understand the long-term effects of teplizumab and how participants are managing their Type 1 diabetes over time with their usual care.

At a glance

Status

Active not recruiting

Sponsor

Provention Bio, a Sanofi Company

Enrolment target

188

Start

26 Oct 2020

Estimated completion

01 Nov 2026

Diabetes Mellitus, Type 1

What is this study about?

You might have heard about a previous important study called PROTECT, which looked at a new treatment called teplizumab for children and teenagers recently diagnosed with Type 1 diabetes. This new study, called the PROTECT Extension, is designed to follow up with those same participants after the first study ended. The main purpose is to gather more long-term information about the safety of teplizumab and to see how young people are getting on with their Type 1 diabetes over time.

Type 1 diabetes is a condition where the body's immune system mistakenly attacks and destroys the cells in the pancreas that produce insulin. Teplizumab is a type of medicine that aims to protect these insulin-producing cells. By continuing to observe participants from the PROTECT study, researchers hope to get a clearer picture of how teplizumab might help manage the condition in the long run and ensure it's safe for long-term use.

It's important to remember that this is an 'observational' study. This means that no new study medicine will be given. Participants will continue with their regular diabetes care as prescribed by their own doctors. The study team will simply be collecting information about their health and how they are managing their diabetes over the next few years. This helps researchers understand the real-world, long-term impact of the treatment they received earlier.

Key takeaways

This is an extension, or follow-up, study to the original PROTECT study.
It aims to check the long-term safety of a treatment called teplizumab for Type 1 diabetes.
No new study medicine will be given during this extension.
Participants will attend regular check-ups for about 3.5 years.
It helps us learn more about managing Type 1 diabetes over time.

Who may be eligible?

This study is specifically for young people who have already finished participating in the original PROTECT study. You must have completed all your visits for that study, including the final one at Week 78, regardless of whether you received the active medication or the dummy treatment.

To join this extension study, you (or your parents/guardians, if you're under 18) will need to give your agreement in writing. This must happen within 12 months of finishing your last visit in the original PROTECT study. If you're under 18, we'll also ask for your written agreement, if you're able to give it.

Unfortunately, if you had to leave the original PROTECT study early for any reason, you won't be able to join this extension study. The study is open to both boys and girls aged 9 to 19 years.

Quick self-check

Did you complete all visits in the original PROTECT study, including the last one at Week 78?
Are you between 9 and 19 years old?
Are you able to agree to take part in writing (or your parents/guardians can)?
Did you finish the PROTECT study less than 12 months ago?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you won't be given any new study medication. Instead, you'll continue with your usual Type 1 diabetes care as advised by your own doctor. The main part of participating will be attending follow-up appointments at the study sites. You'll need to visit the study site once every six months for about three and a half years (42 months).

These visits will involve some assessments to check your health and how your diabetes is being managed. These will be similar to the check-ups you had during the original PROTECT study. When you add this extension study to the original PROTECT study, the total time you would have been involved in these studies combined is about five years.

Potential risks and benefits

Taking part in this study primarily involves follow-up appointments, which may take some time out of your day. There are no direct medical risks from new study drugs, as none are given in this extension. Being part of this research helps increase our understanding of Type 1 diabetes and a new potential treatment, which could benefit others in the future. You are free to withdraw from the study at any time without affecting your medical care.

Locations (47)

Rady Children's Hospital 3020 Children's Way (Site 840004)
San Diego, United States
UCSF Medical Center Gateway Medical Building, 1825 Fourth Street (Site 840001)
San Francisco, United States
Diablo Clinical Research2255 Ygnacio Valley Road, Ste. M (Site 840002)
Walnut Creek, United States
Barbara Davis Center for Diabetes - Pediatrics 1775 Aurora Court (Site 840005)
Aurora, United States
Nemours Children's Health, 807 Children's Way
Jacksonville, United States
Johns Hopkins All Children's Hospital, 501 6th Avenue South (Site 840048)
St. Petersburg, United States
Atlanta Diabetes Associates 1800 Howell Mill Road. Suite 450 (Site 840009)
Atlanta, United States
Centricity Research (Site 840006)
Columbus, United States
St. Luke's Children's Endocrinology, 305 E Jefferson St. (Site 840052)
Boise, United States
Rocky Mountain Clinical Research, LLC 3910 Washington Parkway, Suite E (Site 840007)
Idaho Falls, United States
Indiana University Hospital, Indiana Clinical Research Center, 550 North University Boulevard (Site 840014)
Indianapolis, United States
University of Iowa Hospitals and Clinics 200 Hawkins Drive (Site 840023)
Iowa City, United States

+35 more sites — see the official record for the full list.

Common questions

What is Type 1 diabetes?

Type 1 diabetes is a health condition where your body's immune system mistakenly attacks the cells that make insulin, a hormone needed to turn sugar into energy.

What is teplizumab?

Teplizumab is a medicine that scientists are studying to see if it can help protect the insulin-making cells in people with Type 1 diabetes.

Will I get new medication in this study?

No, you will not receive any new study medication during this extension study. You will continue with your usual diabetes care.

How long will this study last for me?

This extension study itself will last for about three and a half years (42 months), meaning your total involvement with PROTECT studies would be around five years.

Why is this study important?

This study is important because it helps researchers learn more about the long-term safety and effects of teplizumab, which could help future treatments for Type 1 diabetes.