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A Study to Investigate Efficacy and Safety of Teplizumab Compared With Placebo in Participants 1 to 25 Years of Age With Stage 3 Type 1 Diabetes

ConditionType 1 Diabetes Mellitus
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age1-25
SponsorSanofi

About this trial

This is a multicenter, randomized, double-blind, parallel, placebo-controlled Phase 3, 2-arm study for treatment.

The purpose of this study is to measure change in glycemic control and prandial insulin independency over 52 weeks with teplizumab compared with placebo, both administered by intravenous (IV) infusion, in participants with recently diagnosed Stage 3 type 1 diabetes (T1D) aged 1 to 25 years, on standard insulin therapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant must be 1 to 25 years of age inclusive, at the time of signing the informed consent.

Participants diagnosed with T1D Stage 3 according to American Diabetes Association 2025 criteria

Participants able to be randomized and initiate study drug within 8 weeks (56 days) of the Stage 3 T1D diagnosis

Glutamic acid decarboxylase (GAD-65),

Disqualifiers

Participant has diabetes other than autoimmune T1D that includes but is not limited to genetic forms of diabetes, maturity-onset diabetes of the young (MODY), diabetes secondary to medications or surgery and type 2 diabetes by judgement of the Investigator.

Participant has an active serious infection and/or fever ≥38.5°C (101.3°F) within the 48 hours prior to the first dose (except if localized skin infection), or has chronic, recurrent or opportunistic infectious disease.

At screening, participant has laboratory or clinical evidence of acute or clinically active infection with Epstein-Barr virus (EBV), cytomegalovirus (CMV).

At screening, participant has positive serology for human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C (HCV).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Teplizumab

    Drug

    Pharmaceutical form: Concentrated solution for infusion Route of administration: Intravenous infusion

  • Placebo

    Other intervention

    Pharmaceutical form: Concentrated solution for infusion Route of administration: Intravenous infusion

Treatment groups

723 Participants
are divided into 2 treatment groups
Group A: TeplizumabExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

For United States (US) and non-European Union (EU) countries: Glycated hemoglobin (HbA1c) change from baseline

Time frame
From Baseline to Week 52
2

For US and non-EU countries: Total number of days without prandial insulin use

Time frame
From baseline to Week 52
3

For EU countries: Change from baseline in mean 2 hours mixed meal tolerance test (MMTT) stimulated C-peptide concentration, calculated from Area Under the Curve (AUC) in participants 5 years and older

Time frame
From baseline to Week 52
4

For EU countries: HbA1c change from baseline

Time frame
From baseline to Week 52

Secondary outcomes

1

Change from baseline in mean 2 hours MMTT stimulated C-peptide concentration, calculated from AUC

Time frame
From baseline to Week 52
2

Participants remaining C-peptide positive (2 hours MMTT stimulated peak C-peptide concentration ≥0.2 nmol/L)

Time frame
At Week 52
3

Incidence of participants with HbA1c ≤6.5% and requiring ≤0.25 IU/kg/day of insulin

Time frame
At Week 52
4

Change from baseline in Time-in-Range (TIR) (70-180 mg/dL blood glucose) assessed by continuous glucose monitoring (CGM)

Time frame
From baseline to Week 52

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sanofi

Lead sponsor

Source ClinicalTrials.gov
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