Type 1 DiabetesAL1GNNCT07360080
Long-Term Outcomes of Teplizumab in Routine Clinical Care
An observational study of Type 1 Diabetes, run by Sanofi at 10 sites in 3 countries.
Trial summary
This is an observational, prospective cohort study designed to evaluate the outcomes after teplizumab treatment in participants with Stage 2 Type 1 Diabetes (T1D) for delaying the onset of Stage 3 T1D. The study will monitor participants receiving teplizumab as part of routine clinical care across multiple sites. 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
- 1,000 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 19 Mar 2026to 29 Oct 2035
- 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 1000 participants, in 85 sites across 19 countries will be enrolled over 5 years.
Who may be able to join
- Participants who have received at least 1 teplizumab infusion within 6 weeks prior to enrollment.
- Participants must have a confirmed diagnosis of Stage 2 T1D according to the treating physician at the time of the first infusion of teplizumab.
- (Note: Participants who progress to Stage 3 T1D by Week 6 will still be eligible, provided they were in Stage 2 at the time of the first teplizumab infusion.)
- Participants (or their legal guardians, as applicable) who provide appropriate written or electronic informed consent/assent as applicable for the age of the participant and as per local regulations.
Who cannot join
- Participants who had participated in a previous clinical trial for teplizumab.
- Participants enrolled in a clinical trial within 6 months prior to study enrollment.
- (Note: Participants enrolled in other observational studies may be included.)
- 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
10 sites in 3 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
10 sites in 3 countries
United States5 sites, 5 recruiting
- Recruiting
Investigational Site Number: 8400003
Atlanta, Georgia, 30318-2538
- Recruiting
Investigational Site Number: 8400004
Atlanta, Georgia, 30329-3102
- Recruiting
Investigational Site Number: 8400001
New York, New York, 10016
- Recruiting
Investigational Site Number: 8400005
Sandy City, Utah, 84093
- Recruiting
Investigational Site Number: 8400002
Syosset, New York, 11791
Israel3 sites, 3 recruiting
- Recruiting
Investigational Site Number: 3760003
Petah Tikva, 4920235
- Recruiting
Investigational Site Number: 3760002
Ramat Gan, 52621
- Recruiting
Investigational Site Number: 3760001
Ramat Gan, 5265601
United Arab Emirates2 sites, 2 recruiting
- Recruiting
Investigational Site Number: 7840001
Abu Dhabi
- Recruiting
Investigational Site Number: 7840002
Abu Dhabi
About this study
Official title: Long-Term Outcomes of Participants Treated With Teplizumab in Routine Clinical Care
This is an observational, prospective cohort study designed to evaluate the outcomes after teplizumab treatment in participants with Stage 2 Type 1 Diabetes (T1D) for delaying the onset of Stage 3 T1D. The study will monitor participants receiving teplizumab as part of routine clinical care across multiple sites. Additionally, patient-reported outcomes (PROs) will be evaluated to further assess the treatment's impact on participant's quality of life including emotional and psychosocial aspects associated with T1D. This approach will provide a more comprehensive understanding of how the treatment performs over time and across diverse patient populations, providing valuable insights into the sustained effects of teplizumab and offering a real world picture of its impact on the long-term management of T1D.
Read the detailed description
Enrolled participants will be followed for up to 10 years depending on the time the participants are included after initiating teplizumab 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.
Time from teplizumab infusion start to the onset of Stage 3 T1D
Measured: From start of infusion to maximum of 10 years
Secondary outcomes (27)
Proportion of participants who complete teplizumab treatment course
Measured: Up to end of infusion, maximum of 5 years
Number of participants with adverse events during the infusion period
Measured: Till 6 weeks post last infusion, maximum of 5 years
Number of participants with adverse events of special interest and serious adverse events
Measured: From 6 weeks post last infusion through the follow-up, maximum of 10 years
Number of participants with T1D-related complications
Including but not limited to the following: diabetic ketoacidosis, severe hypoglycemia, retinopathy, nephropathy, neuropathy, cardiovascular events
Measured: From infusion up to end of study, maximum of 10 years
Glycemic control assessment values
Measured: From baseline through follow-up, maximum of 10 years
Change from baseline in glycated hemoglobin (HbA1c)
Measured: From baseline through follow-up, maximum of 10 years
Proportion of participants achieving target HbA1c ≤ 6.5%
Measured: From baseline through follow-up, maximum of 10 years
Proportion of participants using home glycemic control assessments (eg, SMBG, CGM)
Measured: From baseline through follow-up, maximum of 10 years
Proportion of participants using glycemic control assessments in-clinic (eg, OGTT, FPG, MMTT, RPG)
Measured: From baseline through follow-up, maximum of 10 years
Mean change from baseline in Time in range (TIR) (70 to 180 mg/dL [3.9 to 10 mmol/L])
CGM reading 70 to 180 mg/dL [3.9 to 10 mmol/L]
Measured: From baseline through follow-up, maximum of 10 years
Mean change from baseline in Time in tight range (TITR) (70 to 140 mg/dL [3.9 to 7.8 mmol/L])
CGM reading 70 to 140 mg/dL [3.9 to 7.8 mmol/L]
Measured: From baseline through follow-up, maximum of 10 years
Mean change from baseline in Time above tight range (TATR): >140 mg/dL (>7.8 mmol/L)
CGM reading >140 mg/dL (>7.8 mmol/L)
Measured: From baseline through follow-up, maximum of 10 years
Mean change from baseline in Time above range (TAR): >180 mg/dL (>10 mmol/L)
CGM reading >180 mg/dL (>10 mmol/L)
Measured: From baseline through follow-up, maximum of 10 years
Mean change from baseline in Time above range (TAR): >250 mg/dL (>13.9 mmol/L)
CGM reading >250 mg/dL (>13.9 mmol/L)
Measured: From baseline through follow-up, maximum of 10 years
Mean change from baseline in Time below range (TBR): <70 mg/dL (<3.9 mmol/L)
CGM reading <70 mg/dL (<3.9 mmol/L)
Measured: From baseline through follow-up, maximum of 10 years
Mean change from baseline in Time below range (TBR): <54 mg/dL (<3.0 mmol/L)
CGM reading <54 mg/dL (<3.0 mmol/L)
Measured: From baseline through follow-up, maximum of 10 years
Mean change from baseline in within-day glucose coefficient of variation
Measured: From baseline through follow-up, maximum of 10 years
Mean change from baseline in between-day glucose coefficient of variation
Measured: From baseline through follow-up, maximum of 10 years
Proportion of participants using insulin during the study period
Continuous subcutaneous insulin infusion, insulin pump, or pump integrated with an automated insulin delivery system
Measured: Up to end of study, maximum of 10 years
Proportion of participants using other glucose lowering therapies during the study period
Measured: Up to end of study, maximum of 10 years
Change in EuroQol 5-Dimensions (EQ-5D) scores in adult and pediatric participants
Measured: From the first posttreatment visit after the last teplizumab infusion through follow-up, for a maximum of 10 years
Change in Hospital Anxiety and Depression Scale (HADS) scores in adult participants
Measured: From the first posttreatment visit after the last teplizumab infusion through follow-up, for a maximum of 10 years
Change in World Health Organization-Five Well-Being Index (WHO-5) scores in pediatric participants
Measured: From the first posttreatment visit after the last teplizumab infusion through follow-up, for a maximum of 10 years
Change in Diabetes Distress Scale (DDS) scores in adult participants
Measured: From the time of Stage 3 T1D confirmation through follow-up, for a maximum of 10 years
Change in Hypoglycemia Fear Survey-II (HFS-II) scores in adult and pediatric participants
Measured: From the time of Stage 3 T1D confirmation through follow-up, for a maximum of 10 years
Annualized rate of hospitalizations due to T1D related disease and complications
Measured: Up to end of study, maximum of 10 years
Annualized rate of emergency room visits related to T1D related disease and complications
Measured: Up to end of study, maximum of 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start19 Mar 2026
- Primary completion29 Oct 2035 (estimated)
- Study completion29 Oct 2035 (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
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07360080
- Sponsor's protocol ID
- OBS18569
- Other IDs
- U1111-1317-7939
- Acronym
- AL1GN
- Status last verified
- Aug 2026
- First submitted
- 14 Jan 2026
- Last updated
- 25 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 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Outcomes of Participants Treated With Teplizumab in Routine Clinical Care
- ClinicalTrials.gov ID
- NCT07360080
- Acronym / sponsor ID
- AL1GN / OBS18569
- Conditions
- Type 1 Diabetes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 19 Mar 2026 (actual)
- Primary completion
- 29 Oct 2035 (estimated)
- Study completion
- 29 Oct 2035 (estimated)
- First posted
- 22 Jan 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 is an observational, prospective cohort study designed to evaluate the outcomes after teplizumab treatment in participants with Stage 2 Type 1 Diabetes (T1D) for delaying the onset of Stage 3 T1D. The study will monitor participants receiving teplizumab as part of routine clinical care across multiple sites. Additionally, patient-reported outcomes (PROs) will be evaluated to further assess the treatment's impact on participant's quality of life including emotional and psychosocial aspects associated with T1D. This approach will provide a more comprehensive understanding of how the treatment performs over time and across diverse patient populations, providing valuable insights into the sustained effects of teplizumab and offering a real world picture of its impact on the long-term management of T1D.
Detailed description
Enrolled participants will be followed for up to 10 years depending on the time the participants are included after initiating teplizumab treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- 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 1000 participants, in 85 sites across 19 countries will be enrolled over 5 years.
Key inclusion criteria (4 listed)
- Participants who have received at least 1 teplizumab infusion within 6 weeks prior to enrollment.
- Participants must have a confirmed diagnosis of Stage 2 T1D according to the treating physician at the time of the first infusion of teplizumab.
- (Note: Participants who progress to Stage 3 T1D by Week 6 will still be eligible, provided they were in Stage 2 at the time of the first teplizumab infusion.)
- Participants (or their legal guardians, as applicable) who provide appropriate written or electronic informed consent/assent as applicable for the age of the participant and as per local regulations.
Key exclusion criteria (4 listed)
- Participants who had participated in a previous clinical trial for teplizumab.
- Participants enrolled in a clinical trial within 6 months prior to study enrollment.
- (Note: Participants enrolled in other observational studies may be included.)
- 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
Time from teplizumab infusion start to the onset of Stage 3 T1D
Time frame: From start of infusion to maximum of 10 years
27 secondary outcomes
Proportion of participants who complete teplizumab treatment course
Time frame: Up to end of infusion, maximum of 5 years
Number of participants with adverse events during the infusion period
Time frame: Till 6 weeks post last infusion, maximum of 5 years
Number of participants with adverse events of special interest and serious adverse events
Time frame: From 6 weeks post last infusion through the follow-up, maximum of 10 years
Number of participants with T1D-related complications
Time frame: From infusion up to end of study, maximum of 10 years
Glycemic control assessment values
Time frame: From baseline through follow-up, maximum of 10 years
Change from baseline in glycated hemoglobin (HbA1c)
Time frame: From baseline through follow-up, maximum of 10 years
Proportion of participants achieving target HbA1c ≤ 6.5%
Time frame: From baseline through follow-up, maximum of 10 years
Proportion of participants using home glycemic control assessments (eg, SMBG, CGM)
Time frame: From baseline through follow-up, maximum of 10 years
Proportion of participants using glycemic control assessments in-clinic (eg, OGTT, FPG, MMTT, RPG)
Time frame: From baseline through follow-up, maximum of 10 years
Mean change from baseline in Time in range (TIR) (70 to 180 mg/dL [3.9 to 10 mmol/L])
Time frame: From baseline through follow-up, maximum of 10 years
Mean change from baseline in Time in tight range (TITR) (70 to 140 mg/dL [3.9 to 7.8 mmol/L])
Time frame: From baseline through follow-up, maximum of 10 years
Mean change from baseline in Time above tight range (TATR): >140 mg/dL (>7.8 mmol/L)
Time frame: From baseline through follow-up, maximum of 10 years
Mean change from baseline in Time above range (TAR): >180 mg/dL (>10 mmol/L)
Time frame: From baseline through follow-up, maximum of 10 years
Mean change from baseline in Time above range (TAR): >250 mg/dL (>13.9 mmol/L)
Time frame: From baseline through follow-up, maximum of 10 years
Mean change from baseline in Time below range (TBR): <70 mg/dL (<3.9 mmol/L)
Time frame: From baseline through follow-up, maximum of 10 years
Mean change from baseline in Time below range (TBR): <54 mg/dL (<3.0 mmol/L)
Time frame: From baseline through follow-up, maximum of 10 years
Mean change from baseline in within-day glucose coefficient of variation
Time frame: From baseline through follow-up, maximum of 10 years
Mean change from baseline in between-day glucose coefficient of variation
Time frame: From baseline through follow-up, maximum of 10 years
Proportion of participants using insulin during the study period
Time frame: Up to end of study, maximum of 10 years
Proportion of participants using other glucose lowering therapies during the study period
Time frame: Up to end of study, maximum of 10 years
Change in EuroQol 5-Dimensions (EQ-5D) scores in adult and pediatric participants
Time frame: From the first posttreatment visit after the last teplizumab infusion through follow-up, for a maximum of 10 years
Change in Hospital Anxiety and Depression Scale (HADS) scores in adult participants
Time frame: From the first posttreatment visit after the last teplizumab infusion through follow-up, for a maximum of 10 years
Change in World Health Organization-Five Well-Being Index (WHO-5) scores in pediatric participants
Time frame: From the first posttreatment visit after the last teplizumab infusion through follow-up, for a maximum of 10 years
Change in Diabetes Distress Scale (DDS) scores in adult participants
Time frame: From the time of Stage 3 T1D confirmation through follow-up, for a maximum of 10 years
Change in Hypoglycemia Fear Survey-II (HFS-II) scores in adult and pediatric participants
Time frame: From the time of Stage 3 T1D confirmation through follow-up, for a maximum of 10 years
Annualized rate of hospitalizations due to T1D related disease and complications
Time frame: Up to end of study, maximum of 10 years
Annualized rate of emergency room visits related to T1D related disease and complications
Time frame: Up to end of study, maximum of 10 years
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 25 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
10 sites in 3 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 10 sites in 3 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 4 inclusion and 4 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 25 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 10 sites in United States, Israel, United Arab Emirates. 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?
Time from teplizumab infusion start to the onset of Stage 3 T1D (time frame: From start of infusion to maximum of 10 years). 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 25 Aug 2026.