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NCT Number: NCT07360080

Long-Term Outcomes of 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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Investigative Site Number: 3760003, Petah Tikva, Israel

Loading trial locations.

About this study

Enrolled participants will be followed for up to 10 years depending on the time the participants are included after initiating teplizumab treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-

  • 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.

Exclusion criteria

-

  • 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.

Treatment and study plan

Teplizumab

Drug

This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.

Primary outcomes

  1. Time from teplizumab infusion start to the onset of Stage 3 T1D

    Time frame: From start of infusion to maximum of 10 years

Secondary outcomes

  1. Proportion of participants who complete teplizumab treatment course

    Time frame: Up to end of infusion, maximum of 5 years

  2. Number of participants with adverse events during the infusion period

    Time frame: Till 6 weeks post last infusion, maximum of 5 years

  3. 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

  4. Number of participants with T1D-related complications

    Time frame: From infusion up to end of study, maximum of 10 years

    Including but not limited to the following: diabetic ketoacidosis, severe hypoglycemia, retinopathy, nephropathy, neuropathy, cardiovascular events

  5. Glycemic control assessment values

    Time frame: From baseline through follow-up, maximum of 10 years

  6. Change from baseline in glycated hemoglobin (HbA1c)

    Time frame: From baseline through follow-up, maximum of 10 years

  7. Proportion of participants achieving target HbA1c ≤ 6.5%

    Time frame: From baseline through follow-up, maximum of 10 years

  8. Proportion of participants using home glycemic control assessments (eg, SMBG, CGM)

    Time frame: From baseline through follow-up, maximum of 10 years

  9. 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

  10. 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

    CGM reading 70 to 180 mg/dL [3.9 to 10 mmol/L]

  11. 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

    CGM reading 70 to 140 mg/dL [3.9 to 7.8 mmol/L]

  12. 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

    CGM reading >140 mg/dL (>7.8 mmol/L)

  13. 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

    CGM reading >180 mg/dL (>10 mmol/L)

  14. 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

    CGM reading >250 mg/dL (>13.9 mmol/L)

  15. 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

    CGM reading <70 mg/dL (<3.9 mmol/L)

  16. 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

    CGM reading <54 mg/dL (<3.0 mmol/L)

  17. Mean change from baseline in within-day glucose coefficient of variation

    Time frame: From baseline through follow-up, maximum of 10 years

  18. Mean change from baseline in between-day glucose coefficient of variation

    Time frame: From baseline through follow-up, maximum of 10 years

  19. Proportion of participants using insulin during the study period

    Time frame: Up to end of study, maximum of 10 years

    Continuous subcutaneous insulin infusion, insulin pump, or pump integrated with an automated insulin delivery system

  20. Proportion of participants using other glucose lowering therapies during the study period

    Time frame: Up to end of study, maximum of 10 years

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. Annualized rate of hospitalizations due to T1D related disease and complications

    Time frame: Up to end of study, maximum of 10 years

  27. Annualized rate of emergency room visits related to T1D related disease and complications

    Time frame: Up to end of study, maximum of 10 years

Study contacts

Contact information is provided by the study sponsor or research team.

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

[email protected]

800-633-1610 ext. Option 6

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Long-Term Outcomes of Participants Treated With Teplizumab in Routine Clinical Care

Acronym: AL1GN

Important dates

Study start
2026
Primary completion
2035
Study completion
2035
First posted
Jan 22, 2026
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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