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
Recruiting · Phase 3 · NCT07088068
Conditions: Type 1 Diabetes Mellitus
At a glance
- Research payments reported, 2025
- $364,787
- U.S. investigators named
- 11
- Sites paid
- 12
- Planned or actual enrollment
- 723
About the trial
- Sponsor
- Sanofi
- Tested
- Teplizumab (drug), Placebo (other)
- Dates
- Started 2025-08-06; completion 2028-12-12
- Results posted
- Not yet
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.
From ClinicalTrials.gov, last updated 2026-10-13. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Sanofi US Services Inc. reported $364,787 in research payments for this study in 2025 (20 payments).
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Abdul-razzak Alamir, MD Endocrinology & Diabetes · Scottsdale, AZ
- Chris Tsimerekis, M.D. Endocrinology & Diabetes · Fountain Valley, CA
- Michelle A. Van Name Pediatric Endocrinology · New Haven, CT
- Bruce W. Bode, M.D. Endocrinology & Diabetes · Atlanta, GA
- Steven B. Leichter, M.D. Endocrinology & Diabetes · Columbus, GA
- Shehzad M. Topiwala, MD Endocrinology & Diabetes · Stockbridge, GA
- Joshua M. Smith, M.D. Pediatric Endocrinology · Idaho Falls, ID
- Yogish C. Kudva, MBBS Endocrinology & Diabetes · Rochester, MN
- Lauren E. Bernstein, M.D. Endocrinology & Diabetes · Asheville, NC
- Kashif A. Latif, M.D. Specialist · Bartlett, TN
- Sandra M. Lord Internal Medicine · Kent, WA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Atlanta Diabetes Associates $82,584
- Rocky Mountain Clinical Research, Llc $64,409
- Yale University Attn Treasury Services $40,411
- Mayo Clinic Cont Nursing Education $26,460
- Cr Services Acquisition Us Llc Centricity Research $25,390
- Benaroya Research Institute at Virg Mason $24,350
- Mayo Clinic $21,582
- Asheville Clinical Research Llc $20,413
- Sitebridge Research Inc $17,637
- Skaz Holdings Llc $14,300
- Phoenix Clinical Trials Scottsdale Clinical Trials $14,125
- Marvel Clinical Research, Llc $13,125
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.