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Teplizumab and β-Cell Function in Newly Diagnosed Type 1 Diabetes
Eleanor L Ramos1, Colin M Dayan1, Lucienne Chatenoud1
1From Provention Bio, a Sanofi company, Red Bank, NJ (E.L.R., L.A.K., W.T.); Cardiff University, Cardiff, United Kingdom (C.M.D.); Université Paris Cité, CNRS, INSERM, Institut Necker Enfants Malades-INEM, Paris (L.C.); the Department of Pediatrics, Motol University Hospital, Second Faculty of Medicine-Charles University, Prague, Czech Republic (Z.S.); the Barbara Davis Center for Diabetes/University of Colorado School of Medicine, Aurora (K.M.S.); the Medical University of Warsaw, Warsaw, Poland (A.S.); the University of California, San Francisco, San Francisco (S.E.G.); Sanofi, Frankfurt, Germany (E.N.); and the Departments of Immunobiology and Internal Medicine, Yale University, New Haven, CT (K.C.H.).
Teplizumab treatment in children and adolescents with newly diagnosed type 1 diabetes demonstrated improved beta-cell function preservation. However, secondary clinical endpoints did not show significant differences between the teplizumab and placebo groups.
Area of Science:
- Immunology
- Endocrinology
- Clinical Trials
Background:
- Teplizumab is an FDA-approved monoclonal antibody for delaying clinical type 1 diabetes in preclinical stages.
- Its efficacy in preventing disease progression in newly diagnosed type 1 diabetes is not yet established.
Purpose of the Study:
- To assess the impact of intravenous teplizumab on beta-cell preservation in children and adolescents with newly diagnosed type 1 diabetes.
- To evaluate clinical endpoints and safety profiles associated with teplizumab treatment.
Main Methods:
- A phase 3, randomized, placebo-controlled trial involving two 12-day courses of teplizumab or placebo.
- Primary endpoint: change in stimulated C-peptide levels at week 78.
- Secondary endpoints: insulin dosage, glycated hemoglobin, time in glucose range, and hypoglycemia events.
Main Results:
- Teplizumab treatment resulted in significantly higher stimulated C-peptide levels at week 78 compared to placebo.
- A higher percentage of teplizumab-treated patients maintained clinically meaningful peak C-peptide levels.
- No significant differences were observed in key secondary clinical endpoints between the groups.
Conclusions:
- Two courses of teplizumab showed a benefit in preserving beta-cell function in newly diagnosed type 1 diabetes.
- No significant differences were found for secondary clinical endpoints, indicating a need for further research.
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