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

A Real-World Retrospective Observational Study Characterizing Patients With Stage 2 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.

Study Overview

• Status: Recruiting
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Drug: Teplizumab

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Trial Transparency email recommended (Toll free for US & Canada); Phone Number: option 6 800-633-1610; Email: Contact-US@sanofi.com

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Recruiting
    • Investigational Site Number: 0560001
• France
  • Bron, France, 69677
    • Recruiting
    • Investigational Site Number: 2500001
  • Paris, France, 75014
    • Recruiting
    • Investigational Site Number: 2500003
  • Paris, France, 75015
    • Recruiting
    • Investigational Site Number: 2500002
• Italy
  • Ancona, Italy, 60123
    • Recruiting
    • Investigational Site Number: 3800001
  • Palermo, Italy, 90127
    • Recruiting
    • Investigational Site Number: 3800003
• Spain
  • Madrid, Spain, 28046
    • Recruiting
    • Investigational Site Number: 7240002
  • Madrid, Spain, 28034
    • Recruiting
    • Investigational Site Number: 7240001
  • Zaragoza, Spain, 50009
    • Recruiting
    • Investigational Site Number: 7240003
• United Kingdom
  • Birmingham, United Kingdom, B4 6NH
    • Recruiting
    • Investigational Site Number: 8260001
  • London, United Kingdom, E1 1BB
    • Recruiting
    • Investigational Site Number: 8260002

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with Stage 2 Type 1 Diabetes (T1D) who received Teplizumab	Drug: Teplizumab; This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants' family history of T1D and autoimmune diseases	First- and second-degree relatives with T1D	At Day 1 (first dose of teplizumab)
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from Stage 1 T1D confirmation to Stage 2 confirmation	Only participants with a date of Stage 1 T1D confirmation will be included in this analysis.	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)
Assessment of blood glucose test results: Random Plasma Glucose (PG)		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: Post-prandial Glucose (PPG)		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: Continuous glucose monitoring (CGM)		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 C-peptide test results		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 autoantibody test results	Anti-GAD65, IAA, Anti-IA-2, ICA, Anti-ZnT8	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)
Proportion of participants who complete teplizumab treatment course		At Day 1 (first dose of teplizumab) until end of follow-up, up to 24 months
Proportion of participants using insulin during the study period		At Day 1 (first dose of teplizumab) until end of follow-up, up to 24 months
Proportion of participants using other glucose lowering therapies during the study period		At Day 1 (first dose of teplizumab) until end of follow-up, up to 24 months

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: February 12, 2026
• First Submitted That Met QC Criteria: March 3, 2026
• First Posted (Actual): March 9, 2026

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 1; teplizumab
• Other Study ID Numbers: OBS20675; U111-1322-8196 (Other Identifier: ICTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No