Skip to content
type1.science
Phase 3RecruitingNCT07088068

BETA PRESERVE: confirmatory teplizumab trial in recent-onset stage-3 T1D

Sanofi's large Phase 3 confirmatory trial for teplizumab in newly diagnosed stage-3 type 1 diabetes. It is recruiting 723 participants aged 1-25 within 56 days of diagnosis and will test whether teplizumab improves HbA1c, prandial-insulin independence, C-peptide, time-in-range and safety outcomes.

Primary endpoints

  • HbA1c change from baseline to week 52
  • Total number of days without prandial insulin use from baseline to week 52
  • In EU countries, change from baseline in 2-hour mixed-meal-tolerance-test stimulated C-peptide AUC at week 52

Results so far

No results yet. The trial is recruiting; ClinicalTrials.gov lists primary completion as June 2028 and final completion as December 2028.

The full picture

BETA PRESERVE is the post-PROTECT confirmatory trial for teplizumab in newly diagnosed stage-3 type 1 diabetes. The FDA's June 2026 accelerated approval for children aged 8-17 rests on preserved C-peptide as a surrogate endpoint; this trial is designed to test whether the treatment also improves outcomes people feel more directly, including HbA1c, mealtime-insulin independence, time-in-range, hypoglycemia and safety.12

Design

The trial is multicenter, randomized, double-blind, parallel and placebo-controlled. It plans to enroll about 723 participants aged 1-25 years who can start treatment within 56 days of stage-3 T1D diagnosis, have at least one T1D autoantibody, and still have measurable C-peptide at screening.3

Endpoints and timing

Primary endpoints differ by region but include HbA1c change, total days without prandial insulin use, and in EU countries stimulated C-peptide AUC on mixed meal tolerance testing. Secondary endpoints include C-peptide positivity, low-insulin/HbA1c composite outcomes, CGM time-in-range, severe hypoglycemia event rates, adverse events, pharmacokinetics and antidrug antibodies.3

ClinicalTrials.gov lists the study as recruiting, with a primary completion estimate of June 2028 and final completion estimate of December 2028.3 Until results report, the stage-3 teplizumab story remains promising but not settled.

References

  1. U.S. Food and Drug Administration. FDA Approves Drug for Pediatric Stage 3 Type I Diabetes. FDA (content current June 12, 2026). https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-drug-pediatric-stage-3-type-i-diabetes ↩

  2. Ramos EL, Dayan CM, Chatenoud L, et al. Teplizumab and beta-Cell Function in Newly Diagnosed Type 1 Diabetes. N Engl J Med (2023). https://doi.org/10.1056/NEJMoa2308743 ↩

  3. Sanofi. 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 (BETA PRESERVE), NCT07088068. ClinicalTrials.gov. https://clinicaltrials.gov/study/NCT07088068 ↩ ↩2 ↩3