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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

Study acronym: βETA PRESERVE
StatusRecruiting
PhasePhase 3
SponsorSanofi
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial sites expanded: 197 → 202 locations
    • Eligibility criteria expanded, about 22 words
    • Secondary endpoints: details revised at 3 of 9 entries
  2. Trial sites expanded: 164 → 197 locationsv23
  3. Study sites revised (164)v22
  4. Study sites: 162 to 164v21
  5. Study sites: 161 to 162
    • Eligibility criteria expanded, about 13 words
    • Study description revised
    v20
  6. Study sites: 159 to 161v19
  7. Trial sites expanded: 153 → 159 locationsv18
  8. Trial sites expanded: 141 → 153 locationsv17
  9. Trial sites expanded: 137 → 141 locationsv16
  10. Trial sites expanded: 124 → 137 locationsv15
  11. Study sites: 107 to 124v14
  12. Study sites: 87 to 107v13
  13. Study sites: 75 to 87v12
  14. Study sites: 54 to 75v11
  15. Primary endpoints: 2 to 5
    • Study sites: 28 to 54
    • Secondary endpoints revised (9)
    v10
  16. Study sites: 17 to 28v9
  17. Study sites: 13 to 17
    • Secondary endpoints revised (9)
    v8
  18. Study sites: 11 to 13v7
  19. Study sites: 10 to 11v6
  20. Study sites: 6 to 10v5
  21. Study sites: 3 to 6v4
  22. Study sites: 2 to 3
    • Start date changed from estimate of Aug 19, 2025 to Aug 6, 2025
    v3
  23. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date: Jul 21, 2025 to Aug 19, 2025
    v2
  24. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Sanofi
284 trials monitored
See 12 trials at risk
Diabetes
5,087 trials monitored
See 222 trials at risk
Type 1 Diabetes
886 trials monitored
See 40 trials at risk
This is a multicenter, randomized, double-blind, parallel, placebo-controlled Phase 3, 2-arm study for treatment. The purpose of this study is to measure change in glycemic control and prandial insulin independency over 52 weeks with teplizumab compared with placebo, both administered by intravenous (IV) infusion, in participants with recently diagnosed Stage 3 type 1 diabetes (T1D) aged 1 to 25 years, on standard insulin therapy.
Trial Details
NCT Number NCT07088068
Lead Sponsor Sanofi
Conditions
(from sponsor)		 Type 1 Diabetes Mellitus
Related terms Diabetes Mellitus, Type 1
Enrollment 723 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov