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Completed

NCT Number: NCT06892002

Description of 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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Disease Attributes Disease Progression Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Schneider Children's Medical Center, Petah Tikva, Israel

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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 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.

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.

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 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)

  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: Genetic risk score

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

  4. Presence of T1D susceptibility genes: Human Leukocyte Antigen (HLA)-haplotype

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

  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 the medical records abstraction date, approximately 3-4 years

    Date of stage 1 confirmation, date of dysglycemia confirmation

  6. 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)"

Secondary outcomes

  1. 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

    Patient monitoring for T1D progression from early to late stages

  2. 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)"

  3. 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)"

  4. 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)"

  5. 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)"

  6. 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)"

  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 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)"

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

  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. 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

    Teplizumab treatment and other treatment variables (insulin, other glucose lowering agents)

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

A Real-World Observational Study Characterizing Patients With Type 1 Diabetes Treated With Teplizumab

Acronym: TEPLI-REAL

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 24, 2025
Registry last updated
Aug 15, 2025

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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