Type 1 DiabetesNCT07457580
Real-World Study of Patients With Type 1 Diabetes Treated With Teplizumab as Part of Managed Access Programs (MAPs)
An observational study of Type 1 Diabetes, run by Sanofi at 14 sites in 6 countries.
Trial summary
This study is a multi-country, multi-center retrospective observational cohort study based on secondary data collected via chart review, with the aim of describing patient characteristics (including relevant comorbidities), monitoring and treatment practices related to Type 1 diabetes mellitus (T1D) progression, and… 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
- 60 participants
- Where
- 14 sitesin 6 countries
- Study dates
- 16 Mar 2026to 30 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 diagnosed with Stage 2 T1D who have received at least 1 teplizumab infusion within 6 weeks prior to enrollment. Approximately 60 participants, in approximately 15 sites across at least 5 countries will be enrolled.
Who may be able to join
- Patient written or electronic 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 as part of MAPs.
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.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
14 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
Trial Transparency email recommended (Toll free for US & Canada) contact
14 sites in 6 countries
France3 sites, 3 recruiting
- Recruiting
Investigational Site Number: 2500001
Bron, 69677
- Recruiting
Investigational Site Number: 2500003
Paris, 75014
- Recruiting
Investigational Site Number: 2500002
Paris, 75015
Italy3 sites, 3 recruiting
- Recruiting
Investigational Site Number: 3800001
Ancona, 60123
- Recruiting
Investigational Site Number: 3800003
Palermo, 90127
- Recruiting
Investigational Site Number: 3800002
Verona, 37126
Spain3 sites, 3 recruiting
- Recruiting
Investigational Site Number: 7240001
Madrid, 28034
- Recruiting
Investigational Site Number: 7240002
Madrid, 28046
- Recruiting
Investigational Site Number: 7240003
Zaragoza, 50009
Germany2 sites, 2 recruiting
- Recruiting
Investigational Site Number: 2760002
Frankfurt, 60596
- Recruiting
Investigational Site Number: 2760001
Hanover, 30173
United Kingdom2 sites, 2 recruiting
- Recruiting
Investigational Site Number: 8260001
Birmingham, B4 6NH
- Recruiting
Investigational Site Number: 8260002
London, E1 1BB
Belgium1 site, 1 recruiting
- Recruiting
Investigational Site Number: 0560001
Leuven, 3000
About this study
Official title: A Real-World Retrospective Observational Study Characterizing Patients With Stage 2 Type 1 Diabetes Treated With Teplizumab as Part of Managed Access Programs (MAPs)
This study is a multi-country, multi-center retrospective observational cohort study based on secondary data collected via chart review, with the aim of describing patient characteristics (including relevant comorbidities), monitoring and treatment practices related to Type 1 diabetes mellitus (T1D) progression, and time to T1D progression in participants who received teplizumab as part of Managed Access Programs (MAPs). This study design was chosen in order to gain rapid insight into the current use of teplizumab in clinical practice and the characteristics of patients who received the treatment.
- Conditions
- Type 1 Diabetes
- Being tested
- Teplizumab
- Medical subject headings
- Diabetes Mellitus, Type 1
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 |
|---|---|---|
| Patients with Stage 2 Type 1 Diabetes (T1D) who received Teplizumab | Not described Receives: Drug: Teplizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant demographics at teplizumab initiation
Age, sex at birth, height, weight, Body mass index (BMI), body surface area
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 medical records abstraction date, approximately 3-4 years
Secondary outcomes (13)
Time from Stage 1 T1D confirmation to Stage 2 confirmation
Only participants with a date of Stage 1 T1D confirmation will be included in this analysis.
Measured: From the date of Stage 1 T1D confirmation to date of first assessment of dysglycemia or positive autoantibody test up to date of first dose of teplizumab (teplizumab initiation), approximately 6 months to a year
Time from Stage 2 T1D confirmation to teplizumab initiation
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 a year
Assessment of blood glucose test results: Glycated hemoglobin (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 test results: 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 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 blood 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 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)
Assessment of autoantibody test 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)
Proportion of participants who complete teplizumab treatment course
Measured: At Day 1 (first dose of teplizumab) until end of follow-up, up to 24 months
Proportion of participants using insulin during the study period
Measured: At Day 1 (first dose of teplizumab) until end of follow-up, up to 24 months
Proportion of participants using other glucose lowering therapies during the study period
Measured: At Day 1 (first dose of teplizumab) until end of follow-up, up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start16 Mar 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07457580
- Sponsor's protocol ID
- OBS20675
- Other IDs
- U111-1322-8196
- Status last verified
- Aug 2026
- First submitted
- 12 Feb 2026
- Last updated
- 26 Aug 2026
- 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 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-World Retrospective Observational Study Characterizing Patients With Stage 2 Type 1 Diabetes Treated With Teplizumab as Part of Managed Access Programs (MAPs)
- ClinicalTrials.gov ID
- NCT07457580
- Acronym / sponsor ID
- OBS20675
- Conditions
- Type 1 Diabetes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 9 Mar 2026 (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.
This study is a multi-country, multi-center retrospective observational cohort study based on secondary data collected via chart review, with the aim of describing patient characteristics (including relevant comorbidities), monitoring and treatment practices related to Type 1 diabetes mellitus (T1D) progression, and time to T1D progression in participants who received teplizumab as part of Managed Access Programs (MAPs). This study design was chosen in order to gain rapid insight into the current use of teplizumab in clinical practice and the characteristics of patients who received the treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Stage 2 Type 1 Diabetes (T1D) who received Teplizumab | – | Drug: Teplizumab |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with Stage 2 T1D who have received at least 1 teplizumab infusion within 6 weeks prior to enrollment. Approximately 60 participants, in approximately 15 sites across at least 5 countries will be enrolled.
Key inclusion criteria (2 listed)
- Patient written or electronic 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 as part of MAPs.
Key exclusion criteria (2 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.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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 | Patients with Stage 2 Type 1 Diabetes (T1D) who received Teplizumab |
Primary outcome
Participant demographics at teplizumab initiation
Time frame: At Day 1 (first dose of teplizumab)
Age, sex at birth, height, weight, Body mass index (BMI), body surface area
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
Time frame: At Day 1 (first dose of teplizumab)
Genetic risk score
Presence of T1D susceptibility genes
Time frame: At Day 1 (first dose of teplizumab)
Human Leukocyte Antigen (HLA)-haplotype
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 medical records abstraction date, approximately 3-4 years
Date of stage 1 confirmation, date of dysglycemia confirmation
13 secondary outcomes
Time from Stage 1 T1D confirmation to Stage 2 confirmation
Time frame: From the date of Stage 1 T1D confirmation to date of first assessment of dysglycemia or positive autoantibody test up to date of first dose of teplizumab (teplizumab initiation), approximately 6 months to a year
Time from Stage 2 T1D confirmation to teplizumab initiation
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 a year
Assessment of blood glucose test results: Glycated hemoglobin (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 test results: 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 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 blood 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 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)
Assessment of autoantibody 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)
Proportion of participants who complete teplizumab treatment course
Time frame: At Day 1 (first dose of teplizumab) until end of follow-up, up to 24 months
Proportion of participants using insulin during the study period
Time frame: At Day 1 (first dose of teplizumab) until end of follow-up, up to 24 months
Proportion of participants using other glucose lowering therapies during the study period
Time frame: At Day 1 (first dose of teplizumab) until end of follow-up, up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- 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.
Trial Transparency email recommended (Toll free for US & Canada) contact
14 sites in 6 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 14 sites in 6 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 2 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: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in France, Italy, Spain, Germany, United Kingdom and 1 more country. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial Transparency email recommended (Toll free for US & Canada) (800-633-1610 ext. Option 6, contact-us@sanofi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant demographics at teplizumab initiation (time frame: At Day 1 (first dose of teplizumab)). The study lists 5 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 26 Aug 2026.