Description of Patients With Type 1 Diabetes Treated With Teplizumab

Recruiting

• Conditions: Type 1 Diabetes
• Interventions: Drug: Teplizumab

• Registration Number: NCT06892002
• Lead Sponsor: Sanofi

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-24
• Study Start: 2025-02-11
• Study First Submitted QC: 2025-03-18
• Study First Posted: 2025-03-24
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-07
• Primary Completion: 2025-07-26
• Study Completion: 2025-07-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Teplizumab treated participants	Teplizumab	Participants who received teplizumab as part of their routine clinical care

Primary Outcome Measures

Name	Time	Method
Assessment of blood glucose test results: 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)"
Participant demographic characteristics at teplizumab initiation	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)
Presence of T1D susceptibility genes: Genetic risk score	At Day 1 (first dose of teplizumab)
Participants' family history of T1D and autoimmune diseases	At Day 1 (first dose of teplizumab)	First- and second-degree relatives with T1D
Presence of T1D susceptibility genes: Human Leukocyte Antigen (HLA)-haplotype	At Day 1 (first dose of teplizumab)
Participants' medical history	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

Secondary Outcome Measures

Name	Time	Method
Development of stages of T1D	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
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: 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 bloog 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 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 autoantibody tests 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)"	Anti-GAD65, IAA, Anti-IA-2, ICA, Anti-ZnT8
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)"
Treatments participants received: teplizumab treatment and other treatments	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)
Assessment of blood glucose test results: 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: 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)"

Trial Locations

Locations (5)

AM Diabetes & Endocrinology Center; 🇺🇸 Bartlett, Tennessee, United States

Atlanta Diabetes Associates; 🇺🇸 Atlanta, Georgia, United States

Ten's Medical PC; 🇺🇸 Staten Island, New York, United States

El Paso Medical Research Institute; 🇺🇸 El Paso, Texas, United States

Diabetes and Endocrine Treatment Specialists; 🇺🇸 Sandy, Utah, United States