Long-Term Outcomes of Teplizumab in Routine Clinical Care (AL1GN)

Long-Term Outcomes of Participants Treated With Teplizumab in Routine Clinical Care

This is an observational, prospective cohort study designed to evaluate the outcomes after teplizumab treatment in participants with Stage 2 Type 1 Diabetes (T1D) for delaying the onset of Stage 3 T1D. The study will monitor participants receiving teplizumab as part of routine clinical care across multiple sites. Additionally, patient-reported outcomes (PROs) will be evaluated to further assess the treatment's impact on participant's quality of life including emotional and psychosocial aspects associated with T1D. This approach will provide a more comprehensive understanding of how the treatment performs over time and across diverse patient populations, providing valuable insights into the sustained effects of teplizumab and offering a real world picture of its impact on the long-term management of T1D.

Study Overview

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

Detailed Description

Enrolled participants will be followed for up to 10 years depending on the time the participants are included after initiating teplizumab treatment.

• Study Type: Observational
• Enrollment (Estimated): 1000

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

• Israel
  • Petah Tikva, Israel, 4920235
    • Recruiting
    • Investigative Site Number: 3760003
  • Ramat Gan, Israel, 5265601
    • Recruiting
    • Investigational Site Number: 3760001
  • Ramat Gan, Israel, 52621
    • Recruiting
    • Investigative Site Number: 3760002
• United Arab Emirates
  • Abu Dhabi, United Arab Emirates
    • Recruiting
    • Investigative Site Number: 7840001
• United States
  • Georgia
    • Atlanta, Georgia, United States, 30318-2538
      • Recruiting
      • Investigational Site Number: 8400003
    • Atlanta, Georgia, United States, 30329-3102
      • Recruiting
      • Investigative Site Number: 8400004
  • New York
    • Syosset, New York, United States, 11791
      • Recruiting
      • Investigative Site Number: 8400002
  • Utah
    • Sandy City, Utah, United States, 84093
      • Recruiting
      • Investigational Site Number: 8400005

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 1000 participants, in 85 sites across 19 countries will be enrolled over 5 years.

Description

Inclusion Criteria -

• Participants who have received at least 1 teplizumab infusion within 6 weeks prior to enrollment.
• Participants must have a confirmed diagnosis of Stage 2 T1D according to the treating physician at the time of the first infusion of teplizumab.

(Note: Participants who progress to Stage 3 T1D by Week 6 will still be eligible, provided they were in Stage 2 at the time of the first teplizumab infusion.)

• Participants (or their legal guardians, as applicable) who provide appropriate written or electronic informed consent/assent as applicable for the age of the participant and as per local regulations.

Exclusion Criteria -

• Participants who had participated in a previous clinical trial for teplizumab.
• Participants enrolled in a clinical trial within 6 months prior to study enrollment.

(Note: Participants enrolled in other observational studies may be included.)

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	Time Frame
Time from teplizumab infusion start to the onset of Stage 3 T1D	From start of infusion to maximum of 10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants who complete teplizumab treatment course		Up to end of infusion, maximum of 5 years
Number of participants with adverse events during the infusion period		Till 6 weeks post last infusion, maximum of 5 years
Number of participants with adverse events of special interest and serious adverse events		From 6 weeks post last infusion through the follow-up, maximum of 10 years
Number of participants with T1D-related complications	Including but not limited to the following: diabetic ketoacidosis, severe hypoglycemia, retinopathy, nephropathy, neuropathy, cardiovascular events	From infusion up to end of study, maximum of 10 years
Glycemic control assessment values		From baseline through follow-up, maximum of 10 years
Change from baseline in glycated hemoglobin (HbA1c)		From baseline through follow-up, maximum of 10 years
Proportion of participants achieving target HbA1c ≤ 6.5%		From baseline through follow-up, maximum of 10 years
Proportion of participants using home glycemic control assessments (eg, SMBG, CGM)		From baseline through follow-up, maximum of 10 years
Proportion of participants using glycemic control assessments in-clinic (eg, OGTT, FPG, MMTT, RPG)		From baseline through follow-up, maximum of 10 years
Mean change from baseline in Time in range (TIR) (70 to 180 mg/dL [3.9 to 10 mmol/L])	CGM reading 70 to 180 mg/dL [3.9 to 10 mmol/L]	From baseline through follow-up, maximum of 10 years
Mean change from baseline in Time in tight range (TITR) (70 to 140 mg/dL [3.9 to 7.8 mmol/L])	CGM reading 70 to 140 mg/dL [3.9 to 7.8 mmol/L]	From baseline through follow-up, maximum of 10 years
Mean change from baseline in Time above tight range (TATR): >140 mg/dL (>7.8 mmol/L)	CGM reading >140 mg/dL (>7.8 mmol/L)	From baseline through follow-up, maximum of 10 years
Mean change from baseline in Time above range (TAR): >180 mg/dL (>10 mmol/L)	CGM reading >180 mg/dL (>10 mmol/L)	From baseline through follow-up, maximum of 10 years
Mean change from baseline in Time above range (TAR): >250 mg/dL (>13.9 mmol/L)	CGM reading >250 mg/dL (>13.9 mmol/L)	From baseline through follow-up, maximum of 10 years
Mean change from baseline in Time below range (TBR): <70 mg/dL (<3.9 mmol/L)	CGM reading <70 mg/dL (<3.9 mmol/L)	From baseline through follow-up, maximum of 10 years
Mean change from baseline in Time below range (TBR): <54 mg/dL (<3.0 mmol/L)	CGM reading <54 mg/dL (<3.0 mmol/L)	From baseline through follow-up, maximum of 10 years
Mean change from baseline in within-day glucose coefficient of variation		From baseline through follow-up, maximum of 10 years
Mean change from baseline in between-day glucose coefficient of variation		From baseline through follow-up, maximum of 10 years
Proportion of participants using insulin during the study period	Continuous subcutaneous insulin infusion, insulin pump, or pump integrated with an automated insulin delivery system	Up to end of study, maximum of 10 years
Proportion of participants using other glucose lowering therapies during the study period		Up to end of study, maximum of 10 years
Change in EuroQol 5-Dimensions (EQ-5D) scores in adult and pediatric participants		From the first posttreatment visit after the last teplizumab infusion through follow-up, for a maximum of 10 years
Change in Hospital Anxiety and Depression Scale (HADS) scores in adult participants		From the first posttreatment visit after the last teplizumab infusion through follow-up, for a maximum of 10 years
Change in World Health Organization-Five Well-Being Index (WHO-5) scores in pediatric participants		From the first posttreatment visit after the last teplizumab infusion through follow-up, for a maximum of 10 years
Change in Diabetes Distress Scale (DDS) scores in adult participants		From the time of Stage 3 T1D confirmation through follow-up, for a maximum of 10 years
Change in Hypoglycemia Fear Survey-II (HFS-II) scores in adult and pediatric participants		From the time of Stage 3 T1D confirmation through follow-up, for a maximum of 10 years
Annualized rate of hospitalizations due to T1D related disease and complications		Up to end of study, maximum of 10 years
Annualized rate of emergency room visits related to T1D related disease and complications		Up to end of study, maximum of 10 years

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2026
• Primary Completion (Estimated): October 29, 2035
• Study Completion (Estimated): October 29, 2035

Study Registration Dates

• First Submitted: January 14, 2026
• First Submitted That Met QC Criteria: January 14, 2026
• First Posted (Actual): January 22, 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: OBS18569; U1111-1317-7939 (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