Real-World Study of Patients With Type 1 Diabetes Treated With Teplizumab as Part of Managed Access Programs (MAPs)

NCT07457580 | Recruiting FDA Drug

• 2 other identifiers: OBS20675U111-1322-8196
• Study Type: observational
• Target: 60
• Locations: 5 countries
• Sites: 11

Brief 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 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

Outcome Measures

Primary Outcomes (5)

• Participant demographics at teplizumab initiation

  Age, sex at birth, height, weight, Body mass index (BMI), body surface area

  At Day 1 (first dose of teplizumab)

• Participants' family history of T1D and autoimmune diseases

  First- and second-degree relatives with T1D

  At Day 1 (first dose of teplizumab)

• Presence of T1D susceptibility genes

  Genetic risk score

  At Day 1 (first dose of teplizumab)

• Presence of T1D susceptibility genes

  Human Leukocyte Antigen (HLA)-haplotype

  At Day 1 (first dose of teplizumab)

• Participants' medical history

  Date of stage 1 confirmation, date of dysglycemia confirmation

  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

  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

  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)

  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)

  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)

  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)

Study Arms (1)

Patients with Stage 2 Type 1 Diabetes (T1D) who received Teplizumab

Drug: Teplizumab

Interventions

Teplizumab DRUG

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

Patients with Stage 2 Type 1 Diabetes (T1D) who received Teplizumab

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (11)

Investigational Site Number: 0560001

Leuven, 3000, Belgium

RECRUITING

Investigational Site Number: 2500001

Bron, 69677, France

RECRUITING

Investigational Site Number: 2500003

Paris, 75014, France

RECRUITING

Investigational Site Number: 2500002

Paris, 75015, France

RECRUITING

Investigational Site Number: 3800001

Ancona, 60123, Italy

RECRUITING

Investigational Site Number: 3800003

Palermo, 90127, Italy

RECRUITING

Investigational Site Number: 7240001

Madrid, 28034, Spain

RECRUITING

Investigational Site Number: 7240002

Madrid, 28046, Spain

RECRUITING

Investigational Site Number: 7240003

Zaragoza, 50009, Spain

RECRUITING

Investigational Site Number: 8260001

Birmingham, B4 6NH, United Kingdom

RECRUITING

Investigational Site Number: 8260002

London, E1 1BB, United Kingdom

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

teplizumab

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

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

CONTACT

800-633-1610; contact-us@sanofi.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: March 9, 2026
• Study Start: March 16, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: May 27, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

IT (2); ES (3); GB (2); FR (3); BE (1)