Description of Patients With Type 1 Diabetes Treated With Teplizumab

NCT06892002 | Completed FDA Drug

• 2 other identifiers: PDE0109U1111-1315-4417
• Study Type: observational
• Target: 110
• Locations: 2 countries
• Sites: 27

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.

Conditions

Type 1 Diabetes

Keywords

Teplizumab; Type 1 Diabetes; Real-world study; Stage 2 Type 1 Diabetes; Stage 3 Type 1 Diabetes; Disease progression; Treatment patterns; Patient monitoring

Outcome Measures

Primary Outcomes (6)

• Participant demographic characteristics at teplizumab initiation

  Age, sex at birth, race (for US participants only), ethnicity (for US participants only), height, weight, Body mass index (BMI)

  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 the medical records abstraction date, approximately 3-4 years

• 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)"

Secondary Outcomes (10)

• 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

• 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 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: 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)"

Study Arms (1)

Teplizumab treated participants

Participants who received teplizumab as part of their routine clinical care

Drug: Teplizumab

Interventions

Teplizumab DRUG

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

Teplizumab treated participants

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 whose index date (teplizumab initiation date) was ≥ 6 weeks before site activation and who meet the eligibility criteria outlined below will be eligible for enrollment into the study.

You may qualify if:

• 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.

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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (27)

Arkansas Children's Hospital Research Institute

Little Rock, Arkansas, 72202, United States

Location

University of California, San Francisco

San Francisco, California, 94158, United States

Location

Barbara Davis Center For Childhood Diabetes

Aurora, Colorado, 80045, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

University of Miami Medical Center

Miami, Florida, 33136, United States

Location

USF Diabetes Center

Tampa, Florida, 33612, United States

Location

Doctor's Clinic

Vero Beach, Florida, 32960, United States

Location

Atlanta Diabetes Associates

Atlanta, Georgia, 30318, United States

Location

Childrens Healthcare of Atlanta

Atlanta, Georgia, 30329, United States

Location

Riley Hospital for Children

Carmel, Indiana, 46032, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Boston Children's Hospital Division of Endocrinology

Boston, Massachusetts, 02115, United States

Location

Atlantic Health

Morristown, New Jersey, 07960, United States

Location

Hassenfeld Children's Hospital at NYU Langone

New York, New York, 10016, United States

Location

Morgan Stanley Children's Hospital

New York, New York, 10032, United States

Location

Ten's Medical PC

Staten Island, New York, 10306, United States

Location

SUNY Upstate Medical University PARENT

Syracuse, New York, 13210, United States

Location

Sanford Research/USD

Fargo, North Dakota, 58122, United States

Location

AM Diabetes & Endocrinology Center

Bartlett, Tennessee, 38133, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

El Paso Medical Research Institute

El Paso, Texas, 79902-4646, United States

Location

University of Utah Hospitals & Clinics

Salt Lake City, Utah, 84108, United States

Location

Diabetes and Endocrine Treatment Specialists

Sandy City, Utah, 84093, United States

Location

Schneider Children's Medical Center

Petah Tikva, 4920235, Israel

Location

Sheba Medical Center

Ramat Gan, 52621, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 6423906, Israel

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Disease Progression

Interventions

teplizumab

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: March 24, 2025
• Study Start: February 11, 2025
• Primary Completion: August 5, 2025
• Study Completion: August 5, 2025
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

US (24); IL (3)