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
A Randomized, Double-blind, Phase 3 Study to Investigate Efficacy and Safety of Teplizumab Compared With Placebo in Participants 1 to 25 Years of Age With Recently Diagnosed Stage 3 Type 1 Diabetes (T1D)
3 other identifiers
interventional
723
16 countries
141
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2025
Typical duration for phase_3
141 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2025
CompletedFirst Posted
Study publicly available on registry
July 28, 2025
CompletedStudy Start
First participant enrolled
August 6, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 6, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 12, 2028
April 23, 2026
April 1, 2026
2.8 years
July 20, 2025
April 22, 2026
Conditions
Outcome Measures
Primary Outcomes (5)
For United States (US) and non-European Union (EU) countries: Glycated hemoglobin (HbA1c) change from baseline
From Baseline to Week 52
For US and non-EU countries: Total number of days without prandial insulin use
From baseline to Week 52
For EU countries: Change from baseline in mean 2 hours mixed meal tolerance test (MMTT) stimulated C-peptide concentration, calculated from Area Under the Curve (AUC) in participants 5 years and older
From baseline to Week 52
For EU countries: HbA1c change from baseline
From baseline to Week 52
For EU countries: Total number of days without prandial insulin use
From baseline to Week 52
Secondary Outcomes (9)
Change from baseline in mean 2 hours MMTT stimulated C-peptide concentration, calculated from AUC
From baseline to Week 52
Participants remaining C-peptide positive (2 hours MMTT stimulated peak C-peptide concentration ≥0.2 nmol/L)
At Week 52
Incidence of participants with HbA1c ≤6.5% and requiring ≤0.25 IU/kg/day of insulin
At Week 52
Change from baseline in Time-in-Range (TIR) (70-180 mg/dL blood glucose) assessed by continuous glucose monitoring (CGM)
From baseline to Week 52
Number of level 2 and 3 (according to American Diabetes Association) hypoglycemic events per participant year (event rates)
From baseline to week 52
- +4 more secondary outcomes
Study Arms (2)
Teplizumab
EXPERIMENTALParticipants will receive teplizumab in increasing doses by intravenous administration
Placebo
PLACEBO COMPARATORParticipants will receive volume matching placebo doses to the Teplizumab arm by intravenous administration
Interventions
Pharmaceutical form: Solution for injection Route of administration: Intravenous infusion
Pharmaceutical form: Solution for injection Route of administration: Intravenous infusion
Eligibility Criteria
You may qualify if:
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Participant must be 1 to 25 years of age inclusive, at the time of signing the informed consent.
- Participants diagnosed with T1D Stage 3 according to American Diabetes Association 2025 criteria
- Participants able to be randomized and initiate study drug within 8 weeks (56 days) of the Stage 3 T1D diagnosis
- Participants must be positive for at least one T1D autoantibody at screening:
- Glutamic acid decarboxylase (GAD-65),
- Insulinoma Antigen-2 (IA-2),
- Zinc-transporter 8 (ZnT8), or
- Insulin (if obtained not later than 14 days after exogenous insulin therapy initiation).
- Islet cell cytoplasmic autoantibodies (ICAs)
- Have random C-peptide level ≥0.2 nmol/L obtained at screening
- Both male and female participants are eligible.
- Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- A female participant is eligible to participate if she is not pregnant, and one of the following conditions applies:
- Is a woman of nonchildbearing potential (WONCBP) OR
- +5 more criteria
You may not qualify if:
- Participants are excluded from the study if any of the following criteria apply:
- Participant has diabetes other than autoimmune T1D that includes but is not limited to genetic forms of diabetes, maturity-onset diabetes of the young (MODY), diabetes secondary to medications or surgery and type 2 diabetes by judgement of the Investigator.
- Participant has an active serious infection and/or fever ≥38.5°C (101.3°F) within the 48 hours prior to the first dose (except if localized skin infection), or has chronic, recurrent or opportunistic infectious disease.
- At screening, participant has laboratory or clinical evidence of acute or clinically active infection with Epstein-Barr virus (EBV), cytomegalovirus (CMV).
- At screening, participant has positive serology for human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C (HCV).
- Participant has evidence of active or latent tuberculosis (TB) as documented by medical history and examination, chest X-rays (posterior anterior and lateral), and/or TB testing. Blood testing (eg, QuantiFERON® TB Gold test) is strongly preferred; if not available, any local approved TB test is allowed.
- Has other autoimmune diseases, (eg, rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, multiple sclerosis, systemic lupus erythematosus etc), except clinically stable autoimmune thyroid disease, or controlled celiac disease (at discretion of Investigator).
- Any clinically significant abnormality identified either in medical/surgical history or during screening evaluation (eg, physical examination, laboratory tests, vital signs), or any adverse event (AE) during screening period which, in the judgment of the investigator, would preclude safe completion of the study or constrains efficacy assessment.
- Participant has recent or planned vaccinations as follows:
- Live-attenuated (live) vaccines (eg, varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, and smallpox) within the 8 weeks before first dose of the investigational medicinal product (IMP) or planned/required administration during treatment or up to 26 weeks after last IMP administration in any treatment course
- Inactivated or mRNA vaccines within 2 weeks before the first dose of IMP or planned required administration during treatment or up to 6 weeks after last IMP administration in any treatment course.
- Current or prior use (within 30 days before screening) of any anti-hyperglycemic agents other than insulin
- Past (within 30 days prior to screening) or current administration of any treatment that is known to cause a significant, ongoing change in the course of T1D or immunologic status (including but not limited to oral, inhaled or systemically injected steroids with duration \>14 days, adrenocorticotropic hormone, verapamil).
- Past systemic immunosuppression medicine or immune modulatory biologic therapy (such as monoclonal antibodies), within 3 months or 5 half-lifes (whichever is longer) prior to dosing.
- Current or prior (within 30 days before screening) use of any medication known to significantly influence glucose tolerance (eg, atypical antipsychotics, diphenylhydantoin, niacin).
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (141)
Scottsdale Clinical Trials- Site Number : 8400044
Scottsdale, Arizona, 85260, United States
Marvel Clinical Research- Site Number : 8400042
Huntington Beach, California, 92647, United States
University of California San Francisco - Mission Bay- Site Number : 8400011
San Francisco, California, 94158, United States
Barbara Davis Center for Childhood Diabetes- Site Number : 8400031
Aurora, Colorado, 80045, United States
Yale University School of Medicine- Site Number : 8400005
New Haven, Connecticut, 06510, United States
University of Florida College of Medicine- Site Number : 8400054
Gainesville, Florida, 32610, United States
Encore Medical Research - Hollywood- Site Number : 8400061
Hollywood, Florida, 33024, United States
University of South Florida- Site Number : 8400013
Tampa, Florida, 33612, United States
Atlanta Diabetes Associates- Site Number : 8400036
Atlanta, Georgia, 30318, United States
IACT Health - Columbus - Talbotton Road- Site Number : 8400003
Columbus, Georgia, 31904, United States
Institute of Endocrinology Diabetes, Health & Hormones- Site Number : 8400050
Stockbridge, Georgia, 30281, United States
St. Luke's Children's Hospital- Site Number : 8400014
Boise, Idaho, 83712, United States
Rocky Mountain Clinical Research - Idaho Falls- Site Number : 8400001
Idaho Falls, Idaho, 83404, United States
C.S. Mott Children's Hospital- Site Number : 8400015
Ann Arbor, Michigan, 48109, United States
Mayo Clinic in Rochester - Minnesota- Site Number : 8400019
Rochester, Minnesota, 55905, United States
Children's Mercy Adelle Hall Campus- Site Number : 8400010
Kansas City, Missouri, 64108, United States
University At Buffalo - Jacobs School Of Medicine- Site Number : 8400006
Buffalo, New York, 14203, United States
Endocrine Associates of West Village- Site Number : 8400064
New York, New York, 10001, United States
Columbia University Irving Medical Center- Site Number : 8400009
New York, New York, 10032, United States
Asheville Clinical Research- Site Number : 8400045
Asheville, North Carolina, 28803, United States
The Ohio State University- Site Number : 8400051
Columbus, Ohio, 43210, United States
The Children's Hospital of Philadelphia- Site Number : 8400039
Philadelphia, Pennsylvania, 19104, United States
AM Diabetes & Endocrinology Center- Site Number : 8400004
Bartlett, Tennessee, 38133, United States
Vanderbilt University Medical Center- Site Number : 8400020
Nashville, Tennessee, 37232, United States
UVA Children's Battle Building- Site Number : 8400060
Charlottesville, Virginia, 22903, United States
Benaroya Research Institute at Virginia Mason- Site Number : 8400038
Seattle, Washington, 98101, United States
Mary Bridge Children's Outpatient Center- Site Number : 8400037
Tacoma, Washington, 98405, United States
Investigational Site Number : 0320003
San Miguel de Tucumán, Tucumán Province, 4000, Argentina
Investigational Site Number : 0320005
Buenos Aires, 1419, Argentina
Investigational Site Number : 0360001
Brisbane, Queensland, 4101, Australia
Investigational Site Number : 0560005
Brussels, 1020, Belgium
Investigational Site Number : 0560009
Brussels, 1070, Belgium
Investigational Site Number : 0560007
Edegem, 2650, Belgium
Investigational Site Number : 0560002
Jette, 1090, Belgium
Investigational Site Number : 0560001
Leuven, 3000, Belgium
Investigational Site Number : 0560008
Leuven, 3000, Belgium
Investigational Site Number : 0560006
Liège, 4000, Belgium
Investigational Site Number : 0560004
Namur, 5000, Belgium
Hospital Universitario Walter Cantidio- Site Number : 0760009
Fortaleza, Ceará, 60430-270, Brazil
Centro de Diabetes Curitiba- Site Number : 0760006
Curitiba, Paraná, 80810-040, Brazil
Centro de Pesquisa Clínica de Marília - CPCLIM- Site Number : 0760002
Marília, São Paulo, 17504-072, Brazil
Hospital Universitario Clementino Fraga Filho- Site Number : 0760008
Rio de Janeiro, 21941-913, Brazil
Centro de Pesquisas Clínicas - São Paulo- Site Number : 0760011
São Paulo, 01228-200, Brazil
Hospital Israelita Albert Einstein- Site Number : 0760001
São Paulo, 05651-901, Brazil
Investigational Site Number : 1240002
Halifax, Nova Scotia, B3H 2Y9, Canada
Investigational Site Number : 1560050
Pingxiang, Colorado, 337055, China
Investigational Site Number : 1560016
Luoyang, New Jersey, 471003, China
Investigational Site Number : 1560035
Beijing, 100020, China
Investigational Site Number : 1560003
Beijing, 100034, China
Investigational Site Number : 1560033
Beijing, 100045, China
Investigational Site Number : 1560009
Changchun, 130041, China
Investigational Site Number : 1560001
Changsha, 410011, China
Investigational Site Number : 1560055
Chengdu, 610072, China
Investigational Site Number : 1560042
Chengdu, 610091, China
Investigational Site Number : 1560007
Guangzhou, 510120, China
Investigational Site Number : 1560037
Guangzhou, 510620, China
Investigational Site Number : 1560040
Hangzhou, 310003, China
Investigational Site Number : 1560014
Hangzhou, 310009, China
Investigational Site Number : 1560012
Hangzhou, 310014, China
Investigational Site Number : 1560010
Harbin, 150001, China
Investigational Site Number : 1560026
Hohhot, 010050, China
Investigational Site Number : 1560059
Jinan, 250001, China
Investigational Site Number : 1560056
Lanzhou, 730000, China
Investigational Site Number : 1560018
Nanchang, 330006, China
Investigational Site Number : 1560043
Nanchang, 330038, China
Investigational Site Number : 1560005
Nanjing, 210008, China
Investigational Site Number : 1560034
Nanjing, 210008, China
Investigational Site Number : 1560054
Nanjing, 210029, China
Investigational Site Number : 1560031
Shanghai, 200032, China
Investigational Site Number : 1560032
Shanghai, 200040, China
Investigational Site Number : 1560013
Shenyang, 110004, China
Investigational Site Number : 1560045
Shenzhen, 518026, China
Investigational Site Number : 1560019
Tianjin, 300052, China
Investigational Site Number : 1560039
Wuhan, 430010, China
Investigational Site Number : 1560002
Wuhan, 430030, China
Investigational Site Number : 1560041
Wuxi, 214023, China
Investigational Site Number : 1560060
Yueyang, 414000, China
Investigational Site Number : 1560038
Zhengzhou, 450018, China
Investigational Site Number : 1560027
Zhenjiang, 212000, China
Investigational Site Number : 2030004
Prague, 128 08, Czechia
Investigational Site Number : 2030003
Prague, 140 21, Czechia
Investigational Site Number : 2030001
Prague, 150 06, Czechia
Investigational Site Number : 2500002
Paris, 75010, France
Investigational Site Number : 2500008
Paris, 75013, France
Investigational Site Number : 2500009
Paris, 75019, France
Investigational Site Number : 2500005
Pau, 64000, France
Investigational Site Number : 2500007
Strasbourg, 67000, France
Investigational Site Number : 2760002
Augsburg, 86156, Germany
Investigational Site Number : 2760008
Bielefeld, 33617, Germany
Investigational Site Number : 2760005
Hanover, 30173, Germany
Investigational Site Number : 2760006
Leipzig, 04103, Germany
Investigational Site Number : 2760010
Munich, 81675, Germany
Investigational Site Number : 2760001
Ulm, 89081, Germany
Investigational Site Number : 3760005
Jerusalem, 9112001, Israel
Investigational Site Number : 3760002
Petah Tikva, 4920235, Israel
Investigational Site Number : 3760003
Petah Tikva, 4941492, Israel
Investigational Site Number : 3760001
Ramat Gan, 5262100, Israel
Investigational Site Number : 3760006
Rehovot, 7610001, Israel
Investigational Site Number : 3760004
Tel Aviv, 6423906, Israel
Azienda Ospedaliera Universitaria Meyer IRCCS - Site Number : 3800001
Florence, Firenze, 50139, Italy
IRCCS Istituto Giannina Gaslini - Site Number : 3800008
Genoa, Genova, 16147, Italy
Ospedale dei Bambini Vittore Buzzi - Site Number : 3800005
Milan, Milano, 20154, Italy
Investigational Site Number : 3800011
Milan, Milano, 20157, Italy
AOU Policlinico Umberto I, UOC Diabetologia -Site Number : 3800012
Rome, Roma, 00161, Italy
Investigational Site Number : 3800003
Rome, Roma, 00165, Italy
Investigational Site Number : 3800010
Turin, Torino, 10126, Italy
Investigational Site Number : 3800014
Messina, 98125, Italy
AOU Maggiore della Carità - Site Number : 3800015
Novara, 28100, Italy
Azienda Ospedaliera Universitaria Integrata di Verona -Site Number : 3800002
Verona, 37126, Italy
Investigational Site Number : 5280002
Leiden, 2333 ZA, Netherlands
Investigational Site Number : 5280001
Rotterdam, 3011 TA, Netherlands
Investigational Site Number : 6160005
Lodz, Lódzkie, 92-213, Poland
Investigational Site Number : 6160001
Warsaw, Masovian Voivodeship, 02-117, Poland
Investigational Site Number : 7240012
Santiago de Compostela, A Coruña [La Coruña], 15706, Spain
Investigational Site Number : 7240017
Barcelona, Barcelona [Barcelona], 08035, Spain
Investigational Site Number : 7240004
Esplugues de Llobregat, Barcelona [Barcelona], 08950, Spain
Investigational Site Number : 7240003
Sabadell, Barcelona [Barcelona], 08208, Spain
Investigational Site Number : 7240020
Barakaldo, Basque Country, 48903, Spain
Investigational Site Number : 7240023
Alcalá de Henares, Madrid, 28805, Spain
Investigational Site Number : 7240016
Pamplona, Navarre, 31008, Spain
Investigational Site Number : 7240014
Pontevedra, Pontevedra [Pontevedra], 36312, Spain
Investigational Site Number : 7240019
San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain
Investigational Site Number : 7240021
Seville, Sevilla, 41009, Spain
Investigational Site Number : 7240001
Seville, Sevilla, 41013, Spain
Investigational Site Number : 7240006
Madrid, 28007, Spain
Investigational Site Number : 7240010
Madrid, 28009, Spain
Investigational Site Number : 7240009
Madrid, 28034, Spain
Investigational Site Number : 7240011
Madrid, 28040, Spain
Investigational Site Number : 7240007
Madrid, 28046, Spain
Investigational Site Number : 7240022
Málaga, 29010, Spain
Investigational Site Number : 7240015
Palma, 07120, Spain
Investigational Site Number : 8260001
Cambridge, Cambridgeshire, CB2 2QQ, United Kingdom
Investigational Site Number : 8260004
Dundee, Dundee City, DD1 9SY, United Kingdom
Investigational Site Number : 8260009
London, England, E1 1BB, United Kingdom
Investigational Site Number : 8260012
London, England, SW10 9NH, United Kingdom
Investigational Site Number : 8260002
Glasgow, Glasgow City, G51 4TF, United Kingdom
Investigational Site Number : 8260007
London, London, City of, SE5 9RL, United Kingdom
Investigational Site Number : 8260011
Bath, Somerset, BA1 3NG, United Kingdom
Investigational Site Number : 8260006
Guildford, Surrey, GU2 7XX, United Kingdom
Investigational Site Number : 8260005
Leeds, LS9 7TF, United Kingdom
Investigational Site Number : 8260010
Reading, RG1 5AN, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2025
First Posted
July 28, 2025
Study Start
August 6, 2025
Primary Completion (Estimated)
June 6, 2028
Study Completion (Estimated)
December 12, 2028
Last Updated
April 23, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org