Type 1 DiabetesTEPLI-REALNCT06892002
Description of Patients With Type 1 Diabetes Treated With Teplizumab
An observational study of Type 1 Diabetes, run by Sanofi at 27 sites in 2 countries.
Trial summary
Type 1 diabetes mellitus (T1D) is a chronic autoimmune disease caused by the destruction of pancreatic β cells. T1D pathogenesis progresses through several stages: Stage 1 T1D includes the presence of β cell autoimmunity and thus presence of islet autoantibodies, without the presence of dysglycemia and symptoms. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Teplizumab
- How many people
- 110 participants
- Where
- 27 sitesin 2 countries
- Study dates
- 11 Feb 2025to 5 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients whose index date (teplizumab initiation date) was ≥ 6 weeks before site activation and who meet the eligibility criteria outlined below will be eligible for enrollment into the study.
Who may be able to join
- Patient informed consent or assent (for patients < 18 years old) according to local regulations or appropriate informed consent waivers prior to any study related activity.
- Patient received ≥ 1 day of teplizumab treatment.
Who cannot join
- Participation in an interventional clinical study on the index date. Participation in an interventional clinical study is defined as initiating the product/procedure or control under investigation. An interventional clinical study is a study that requires deviation from standard clinical practice by following a study protocol.
Trial locations and contacts
27 sites in 2 countries.
27 sites in 2 countries
United States24 sites
Atlanta Diabetes Associates
Atlanta, Georgia, 30318
Childrens Healthcare of Atlanta
Atlanta, Georgia, 30329
Barbara Davis Center For Childhood Diabetes
Aurora, Colorado, 80045
AM Diabetes & Endocrinology Center
Bartlett, Tennessee, 38133
Boston Children's Hospital Division of Endocrinology
Boston, Massachusetts, 02115
Riley Hospital for Children
Carmel, Indiana, 46032
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
El Paso Medical Research Institute
El Paso, Texas, 79902-4646
Sanford Research/USD
Fargo, North Dakota, 58122
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, 72202
University of Louisville
Louisville, Kentucky, 40202
University of Miami Medical Center
Miami, Florida, 33136
Atlantic Health
Morristown, New Jersey, 07960
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Hassenfeld Children's Hospital at NYU Langone
New York, New York, 10016
Morgan Stanley Children's Hospital
New York, New York, 10032
University of Utah Hospitals & Clinics
Salt Lake City, Utah, 84108
University of California, San Francisco
San Francisco, California, 94158
Diabetes and Endocrine Treatment Specialists
Sandy City, Utah, 84093
Ten's Medical PC
Staten Island, New York, 10306
SUNY Upstate Medical University PARENT
Syracuse, New York, 13210
USF Diabetes Center
Tampa, Florida, 33612
Doctor's Clinic
Vero Beach, Florida, 32960
Children's National Medical Center
Washington D.C., District of Columbia, 20010
Israel3 sites
Schneider Children's Medical Center
Petah Tikva, 4920235
Sheba Medical Center
Ramat Gan, 52621
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906
About this study
Official title: A Real-World Observational Study Characterizing Patients With Type 1 Diabetes Treated With Teplizumab
Type 1 diabetes mellitus (T1D) is a chronic autoimmune disease caused by the destruction of pancreatic β cells. T1D pathogenesis progresses through several stages: Stage 1 T1D includes the presence of β cell autoimmunity and thus presence of islet autoantibodies, without the presence of dysglycemia and symptoms. Stage 2 T1D includes the presence of islet autoantibodies and dysglycemia, also with no symptoms. Stage 3 T1D includes presence of islet autoantibodies, overt hyperglycemia, and symptoms; most patients with Stage 3 T1D meet standard diagnostic criteria for diabetes and require insulin treatment.
Teplizumab has been shown to delay progression to Stage 3 in participants at Stage 2 in a Phase 2 clinical trial, leading to subsequent approval in the United States of America (USA). Patients outside of the USA are able to receive the treatment through Pre-Registration Import Licenses and Managed Access Programs. The current study will collect data on the use of teplizumab in routine care, to better understand which patients received teplizumab and how these patients were managed after they received the treatment.
- Conditions
- Type 1 Diabetes
- Being tested
- Teplizumab
- Keywords
- Teplizumab, Type 1 Diabetes, Real-world study, Stage 2 Type 1 Diabetes, Stage 3 Type 1 Diabetes, Disease progression, Treatment patterns, Patient monitoring
- Medical subject headings
- Diabetes Mellitus, Type 1, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeplizumabDrug
This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Teplizumab treated participants | Participants who received teplizumab as part of their routine clinical care Receives: Drug: Teplizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant demographic characteristics at teplizumab initiation
Age, sex at birth, race (for US participants only), ethnicity (for US participants only), height, weight, Body mass index (BMI)
Measured: At Day 1 (first dose of teplizumab)
Participants' family history of T1D and autoimmune diseases
First- and second-degree relatives with T1D
Measured: At Day 1 (first dose of teplizumab)
Presence of T1D susceptibility genes: Genetic risk score
Measured: At Day 1 (first dose of teplizumab)
Presence of T1D susceptibility genes: Human Leukocyte Antigen (HLA)-haplotype
Measured: At Day 1 (first dose of teplizumab)
Participants' medical history
Date of stage 1 confirmation, date of dysglycemia confirmation
Measured: From 6 months prior to the first dose of teplizumab (teplizumab initiation) (or the earliest date of all data contributing to Stage 2 T1D diagnosis, whichever is earlier) up to the medical records abstraction date, approximately 3-4 years
Assessment of blood glucose test results: CGM
Measured: At screening (6 months before teplizumab initiation), within 6 weeks prior to teplizumab initiation, during teplizumab infusion (2 weeks), following completion of teplizumab treatment (through study completion, up to 30 months)"
Secondary outcomes (10)
Development of stages of T1D
Patient monitoring for T1D progression from early to late stages
Measured: From the date of first assessment of dysglycemia or positive autoantibody test up to date of first dose of teplizumab (teplizumab initiation), approximately 6 months to 1 year
Assessment of blood glucose test results: HbA1c
Measured: At screening (6 months before teplizumab initiation), within 6 weeks prior to teplizumab initiation, during teplizumab infusion (2 weeks), following completion of teplizumab treatment (through study completion, up to 30 months)"
Assessment of blood glucose test results: Fasting Plasma Glucose (FPG)
Measured: At screening (6 months before teplizumab initiation), within 6 weeks prior to teplizumab initiation, during teplizumab infusion (2 weeks), following completion of teplizumab treatment (through study completion, up to 30 months)"
Assessment of blood glucose: Oral glucose tolerance test (OGTT)
Measured: At screening (6 months before teplizumab initiation), within 6 weeks prior to teplizumab initiation, during teplizumab infusion (2 weeks), following completion of teplizumab treatment (through study completion, up to 30 months)"
Assessment of blood glucose test results: Random Plasma Glucose (PG)
Measured: At screening (6 months before teplizumab initiation), within 6 weeks prior to teplizumab initiation, during teplizumab infusion (2 weeks), following completion of teplizumab treatment (through study completion, up to 30 months)"
Assessment of bloog glucose test results: Continuous glucose monitoring (CGM)
Measured: At screening (6 months before teplizumab initiation), within 6 weeks prior to teplizumab initiation, during teplizumab infusion (2 weeks), following completion of teplizumab treatment (through study completion, up to 30 months)"
Assessment of blood glucose test results: Post-prandial glucose (PPG)
Measured: At screening (6 months before teplizumab initiation), within 6 weeks prior to teplizumab initiation, during teplizumab infusion (2 weeks), following completion of teplizumab treatment (through study completion, up to 30 months)"
Assessment of autoantibody tests results
Anti-GAD65, IAA, Anti-IA-2, ICA, Anti-ZnT8
Measured: At screening (6 months before teplizumab initiation), within 6 weeks prior to teplizumab initiation, during teplizumab infusion (2 weeks), following completion of teplizumab treatment (through study completion, up to 30 months)"
Assessment of C-peptide test results
Measured: At screening (6 months before teplizumab initiation), within 6 weeks prior to teplizumab initiation, during teplizumab infusion (2 weeks), following completion of teplizumab treatment (through study completion, up to 30 months)"
Treatments participants received: teplizumab treatment and other treatments
Teplizumab treatment and other treatment variables (insulin, other glucose lowering agents)
Measured: From earliest of 6 months or the earliest date of all data contributing to Stage 2 T1D diagnosis (i.e. first record of dysglycemia and/or positive autoantibody test) and after teplizumab treatment until end of follow-up, approximately 3-4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start11 Feb 2025
- Primary completion5 Aug 2025
- Study completion5 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06892002
- Sponsor's protocol ID
- PDE0109
- Other IDs
- U1111-1315-4417
- Acronym
- TEPLI-REAL
- Status last verified
- Aug 2025
- First submitted
- 24 Jan 2025
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-World Observational Study Characterizing Patients With Type 1 Diabetes Treated With Teplizumab
- ClinicalTrials.gov ID
- NCT06892002
- Acronym / sponsor ID
- TEPLI-REAL / PDE0109
- Conditions
- Type 1 Diabetes
- Keywords
- Teplizumab, Type 1 Diabetes, Real-world study, Stage 2 Type 1 Diabetes, Stage 3 Type 1 Diabetes, Disease progression, Treatment patterns, Patient monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 11 Feb 2025 (actual)
- Primary completion
- 5 Aug 2025 (actual)
- Study completion
- 5 Aug 2025 (actual)
- First posted
- 24 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Type 1 diabetes mellitus (T1D) is a chronic autoimmune disease caused by the destruction of pancreatic β cells. T1D pathogenesis progresses through several stages: Stage 1 T1D includes the presence of β cell autoimmunity and thus presence of islet autoantibodies, without the presence of dysglycemia and symptoms. Stage 2 T1D includes the presence of islet autoantibodies and dysglycemia, also with no symptoms. Stage 3 T1D includes presence of islet autoantibodies, overt hyperglycemia, and symptoms; most patients with Stage 3 T1D meet standard diagnostic criteria for diabetes and require insulin treatment.
Teplizumab has been shown to delay progression to Stage 3 in participants at Stage 2 in a Phase 2 clinical trial, leading to subsequent approval in the United States of America (USA). Patients outside of the USA are able to receive the treatment through Pre-Registration Import Licenses and Managed Access Programs. The current study will collect data on the use of teplizumab in routine care, to better understand which patients received teplizumab and how these patients were managed after they received the treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Teplizumab treated participants | – | Drug: TeplizumabParticipants who received teplizumab as part of their routine clinical care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients whose index date (teplizumab initiation date) was ≥ 6 weeks before site activation and who meet the eligibility criteria outlined below will be eligible for enrollment into the study.
Key inclusion criteria (2 listed)
- Patient informed consent or assent (for patients < 18 years old) according to local regulations or appropriate informed consent waivers prior to any study related activity.
- Patient received ≥ 1 day of teplizumab treatment.
Key exclusion criteria (1 listed)
- Participation in an interventional clinical study on the index date. Participation in an interventional clinical study is defined as initiating the product/procedure or control under investigation. An interventional clinical study is a study that requires deviation from standard clinical practice by following a study protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeplizumabThis study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice. | Drug | Teplizumab treated participants |
Primary outcome
Participant demographic characteristics at teplizumab initiation
Time frame: At Day 1 (first dose of teplizumab)
Age, sex at birth, race (for US participants only), ethnicity (for US participants only), height, weight, Body mass index (BMI)
Participants' family history of T1D and autoimmune diseases
Time frame: At Day 1 (first dose of teplizumab)
First- and second-degree relatives with T1D
Presence of T1D susceptibility genes: Genetic risk score
Time frame: At Day 1 (first dose of teplizumab)
Presence of T1D susceptibility genes: Human Leukocyte Antigen (HLA)-haplotype
Time frame: At Day 1 (first dose of teplizumab)
Participants' medical history
Time frame: From 6 months prior to the first dose of teplizumab (teplizumab initiation) (or the earliest date of all data contributing to Stage 2 T1D diagnosis, whichever is earlier) up to the medical records abstraction date, approximately 3-4 years
Date of stage 1 confirmation, date of dysglycemia confirmation
Assessment of blood glucose test results: CGM
Time frame: At screening (6 months before teplizumab initiation), within 6 weeks prior to teplizumab initiation, during teplizumab infusion (2 weeks), following completion of teplizumab treatment (through study completion, up to 30 months)"
10 secondary outcomes
Development of stages of T1D
Time frame: From the date of first assessment of dysglycemia or positive autoantibody test up to date of first dose of teplizumab (teplizumab initiation), approximately 6 months to 1 year
Assessment of blood glucose test results: HbA1c
Time frame: At screening (6 months before teplizumab initiation), within 6 weeks prior to teplizumab initiation, during teplizumab infusion (2 weeks), following completion of teplizumab treatment (through study completion, up to 30 months)"
Assessment of blood glucose test results: Fasting Plasma Glucose (FPG)
Time frame: At screening (6 months before teplizumab initiation), within 6 weeks prior to teplizumab initiation, during teplizumab infusion (2 weeks), following completion of teplizumab treatment (through study completion, up to 30 months)"
Assessment of blood glucose: Oral glucose tolerance test (OGTT)
Time frame: At screening (6 months before teplizumab initiation), within 6 weeks prior to teplizumab initiation, during teplizumab infusion (2 weeks), following completion of teplizumab treatment (through study completion, up to 30 months)"
Assessment of blood glucose test results: Random Plasma Glucose (PG)
Time frame: At screening (6 months before teplizumab initiation), within 6 weeks prior to teplizumab initiation, during teplizumab infusion (2 weeks), following completion of teplizumab treatment (through study completion, up to 30 months)"
Assessment of bloog glucose test results: Continuous glucose monitoring (CGM)
Time frame: At screening (6 months before teplizumab initiation), within 6 weeks prior to teplizumab initiation, during teplizumab infusion (2 weeks), following completion of teplizumab treatment (through study completion, up to 30 months)"
Assessment of blood glucose test results: Post-prandial glucose (PPG)
Time frame: At screening (6 months before teplizumab initiation), within 6 weeks prior to teplizumab initiation, during teplizumab infusion (2 weeks), following completion of teplizumab treatment (through study completion, up to 30 months)"
Assessment of autoantibody tests results
Time frame: At screening (6 months before teplizumab initiation), within 6 weeks prior to teplizumab initiation, during teplizumab infusion (2 weeks), following completion of teplizumab treatment (through study completion, up to 30 months)"
Assessment of C-peptide test results
Time frame: At screening (6 months before teplizumab initiation), within 6 weeks prior to teplizumab initiation, during teplizumab infusion (2 weeks), following completion of teplizumab treatment (through study completion, up to 30 months)"
Treatments participants received: teplizumab treatment and other treatments
Time frame: From earliest of 6 months or the earliest date of all data contributing to Stage 2 T1D diagnosis (i.e. first record of dysglycemia and/or positive autoantibody test) and after teplizumab treatment until end of follow-up, approximately 3-4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
27 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes, run by Sanofi at 27 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant demographic characteristics at teplizumab initiation (time frame: At Day 1 (first dose of teplizumab)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.