BETA PRESERVE: confirmatory teplizumab trial in recent-onset stage-3 T1D
What this study tests
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.
Editorial review: .
Registry checked: 2026-09-17. Registry’s own update: 2026-09-14.
Most recent recorded citation date: 2026-06-12. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.
Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence
Evidence at a glance
- Who can enter the study?
- Participants aged 1-25 with recently diagnosed stage-3 autoimmune T1D, able to start study drug within 56 days of diagnosis, positive for at least one T1D autoantibody, and with random C-peptide at least 0.2 nmol/L at screening. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
- Reported benefit and results
- No results yet. The trial is recruiting; ClinicalTrials.gov lists primary completion as June 2028 and final completion as December 2028.Read the result sources and their limitations →
- Important harms
- Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
- Research access and approval
- Study regions: United States, United Kingdom, European Union, Canada, Australia, Japan, Other regions. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
- What remains uncertain?
- Read the full discussion and original sources for study limitations. Planned endpoints and completion dates are not results.
Research status alone does not establish approval, clinical benefit or local availability.
Australian sites in the registry
- Investigational Site Number : 0360001, Brisbane, Queensland — Recruiting
- Investigational Site Number : 0360003, Adelaide, South Australia — Recruiting
- Investigational Site Number : 0360002, Perth, Western Australia — Recruiting
Overall recruitment does not imply availability at every site. Confirm eligibility and local recruitment with the study team.
Primary endpoints
- HbA1c change from baseline to week 52 (US, non-EU and EU countries).
- Total days without prandial insulin use through week 52 (US, non-EU and EU countries).
- EU countries: change in two-hour mixed-meal stimulated C-peptide, calculated from AUC, at week 52 in participants aged five years and older.
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.23
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.1
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 on mixed meal tolerance testing in participants aged five years and older. 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.1
ClinicalTrials.gov lists the study as recruiting, with a primary completion estimate of June 2028 and final completion estimate of December 2028.1 Until results report, the stage-3 teplizumab story remains promising but not settled.
Sources
- [1]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 · Trial registry · 2025-07-28 — ClinicalTrials.gov update posted 14 September 2026, checked 16 September: recruiting, estimated enrollment 723; primary completion 6 June 2028 and final completion 12 December 2028.
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.
- [2]FDA Approves Drug for Pediatric Stage 3 Type I Diabetes · Regulatory decision · 2026-06-12 — FDA accelerated approval of teplizumab for newly diagnosed stage-3 T1D in ages 8-17; BETA PRESERVE is the confirmatory trial.
U.S. Food and Drug Administration. FDA Approves Drug for Pediatric Stage 3 Type I Diabetes. FDA (content current June 12, 2026).
- [3]Teplizumab and beta-Cell Function in Newly Diagnosed Type 1 Diabetes · Peer-reviewed study · 2023-10-18 — PROTECT phase 3 trial supporting the stage-3 accelerated approval.
Ramos EL, Dayan CM, Chatenoud L, et al. Teplizumab and beta-Cell Function in Newly Diagnosed Type 1 Diabetes. N Engl J Med (2023).