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NCT Number: NCT07457580

Real-World Study of Patients With 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.

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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

Investigational Site Number: 0560001, Leuven, Belgium

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

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. 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

  2. Participants' family history of T1D and autoimmune diseases

    Time frame: At Day 1 (first dose of teplizumab)

    First- and second-degree relatives with T1D

  3. Presence of T1D susceptibility genes

    Time frame: At Day 1 (first dose of teplizumab)

    Genetic risk score

  4. Presence of T1D susceptibility genes

    Time frame: At Day 1 (first dose of teplizumab)

    Human Leukocyte Antigen (HLA)-haplotype

  5. 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

Secondary outcomes

  1. 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

    Only participants with a date of Stage 1 T1D confirmation will be included in this analysis.

  2. 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

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

    Anti-GAD65, IAA, Anti-IA-2, ICA, Anti-ZnT8

  11. 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

  12. 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

  13. 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

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

A Real-World Retrospective Observational Study Characterizing Patients With Stage 2 Type 1 Diabetes Treated With Teplizumab as Part of Managed Access Programs (MAPs)

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 9, 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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