Trial Testing Tzield in Youth With Newly Diagnosed Type 1 Diabetes

Trial Status: Recruiting

Clinical Trials Identifier: NCT07088068

Trial Name: A Study to Investigate Efficacy and Safety of Teplizumab Compared With Placebo in Participants 1 to 25 Years of Age With Stage 3 Type 1 Diabetes (βETA PRESERVE)

Diabetes Type: Type 1 diabetes

Trial Sponsor: Sanofi

Why is this study important?

Teplizumab (Tzield) is the first medication approved to delay the onset of stage 3 type 1 diabetes – which is when the blood sugar levels are too high and insulin treatment is required – in people ages 8 and older. 

This new trial is testing whether Tzield can also help those under the age of 25 who have been recently diagnosed with stage 3 type 1 diabetes by improving their A1C and reducing the need for mealtime insulin. Right now, Tzield is approved for people with stage 2 type 1 diabetes, which is when two or more diabetes-related autoantibodies are present and blood sugar levels are abnormally high, but not high enough to need treatment or cause symptoms.

If successful, this could mean better blood sugar management and less reliance on insulin for children and young adults who are newly diagnosed with stage 3 type 1 diabetes.

How does the trial work?

Participants will be randomly assigned to the treatment group or a placebo group. Those assigned to the treatment group will receive the Tzield IV infusion in increasing doses throughout 52 weeks. The placebo group will also receive infusions, but of placebo (without the medication). The study duration for one participant will be approximately 84 weeks (18 months). 

To determine the safety and effectiveness of Tzield in this population, researchers will measure outcomes such as changes to A1C, the number of days without any mealtime insulin use, and changes in time in range (70-180 mg/dL) using continuous glucose monitoring (CGM).

Are you interested in participating?

Individuals between 1-25 years of age are eligible to participate if they:

• Have a diagnosis of stage 3 type 1 diabetes within eight weeks of starting the study
• Have at least one positive type 1 diabetes autoantibody:
  • Glutamic acid decarboxylase (GAD-65),
  • Insulinoma antigen-2 (IA-2),
  • Zinc-transporter 8 (ZnT8),
  • Insulin autoantibodies (IAA), or
  • Islet cell cytoplasmic autoantibodies (ICAs)
• Can start the study drug within eight weeks (56 days) of the stage 3 type 1 diabetes diagnosis

This study is recruiting at multiple locations across the U.S., U.K., and China. See a full list of inclusion/exclusion criteria here.

Learn more about type 1 diabetes prevention and screening here:

• Could Tzield Help Children Newly Diagnosed with Diabetes?
• From Uncertainty to Empowerment: How To Prepare for Type 1 Screening
• Type 1 Diabetes: It's Time for Population-Wide Screening