Teplizumab

Teplizumab Prevention Study

We are testing the drug teplizumab (Anti-CD3) to see if it can delay or prevent early stage T1D (stage 2) from progressing to clinical diagnosis (stage 3). In earlier studies, teplizumab helped people with a new T1D clinical diagnosis (stage 3) keep making their own insulin longer.

Eligibility 
Participants in Stage 2
Type 
Prevention Study
Status 
Currently Not Enrolling

Stages of T1D

Type 1 Diabetes: Stage 2

Info graphic showing the stages of Type 1 Diabetes, and how stage 2 fits in the picture.

In stage 2, blood sugar levels become abnormal, but there are still no symptoms of T1D.

About the Study

Study Details

Teplizumab (Anti-CD3) interferes with the auto-immune response that can result in progression of T1D. Multiple previous clinical trials have shown the benefit of this drug in prolonging insulin production in people recently diagnosed.    Your body’s ability to keep making insulin, even in small amounts, is your best defense against complications and helps you better manage the disease.   

Over 500 children have participated in clinical studies testing teplizumab. Children and others enrolled soon after diagnosis responded most positively to the drug. 

Teplizumab has a good safety profile. 

Based on these promising findings, we are now testing teplizumab in people in early stage T1D (stage 2). Our goal is to prolong insulin production to prevent disease progression. 

As with any medical intervention, there are risks and benefits to participating in this study. Before you decide to participate, a member of our research team will explain all potential risks and benefits and answer any questions you may have. 

 

Eligibility Requirements

Who can participate?

To find out if this study is right for you, the first step is to sign up for Pathway to Prevention screening. To qualify for this study you need to:

•    be between the ages of 8 and 45
•    have two or more diabetes-related autoantibodies (determined by screening)
•    have abnormal results on an oral glucose tolerance test (OGTT)
•    NOT have taken teplizumab or similar drug in the past year
•    NOT have had a “live” vaccine within 6 weeks of joining the study
•    NOT be pregnant or planning to be pregnant
•    meet all study requirements
 

Participant Experience

What is required?

The Teplizumab Prevention Study has two phases: treatment and follow up. 

In the treatment phase, participants make daily visits to a TrialNet site for 14 days in a row. Each visit takes about 4 hours and includes a 30-minute intravenous infusion (I.V.), followed by two hours of observation.

In the follow up phase, participants return for visits until the study is over or until they develop T1D:  

•    Year 1: Visits at 20 days, 6 weeks, 3 months, 6 months, and 12 months
•    Years 2 and beyond: Visits two times a year

Half the people in the study will get the study drug. The other half will get a placebo (looks like the study drug but is inactive). A computer randomly selects who gets the study drug, and no one knows who is in which group until the end of the study. 

Regardless of which group you are in, you play an important role in advancing T1D research for the immediate study and well into the future. Once the study is over, blood samples from participants in the placebo arm of the study are used in other studies looking to answer questions about how T1D progresses and how to stop it. 

All study participants receive close monitoring. If you develop T1D, our tests will likely show this before you have any symptoms. For people taking part in T1D research, the risk of diabetic ketoacidosis (DKA) at diagnosis drops from 30% to less than 4%. DKA is a serious condition that can be life-threatening. 

With early notification, you will be able to see your doctor and start taking insulin before you feel sick. If there aren’t any studies for newly diagnosed T1D that are right for you, we will invite you to take part in long-term follow up.