PROTECT
Trial question
What is the role of teplizumab in patients with newly diagnosed T1DM?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
43.0% female
57.0% male
N = 328
328 patients (140 female, 188 male).
Inclusion criteria: children and adolescents with newly diagnosed T1DM.
Key exclusion criteria: major systemic illnesses; active infection; history of chronic infection.
Interventions
N=217 teplizumab (total cumulative intravenous dose of 9 mg/m² in two 12-day courses).
N=111 placebo (intravenous matching volumes and schedule in two 12-day courses).
Primary outcome
Decline in stimulated C-peptide levels at week 78
0.09
0.21
0.2 pmol/mL
0.2 pmol/mL
0.1 pmol/mL
0.1 pmol/mL
0.0 pmol/mL
Teplizumab
Placebo
Significant
decrease ▼
Significant decrease in decline in stimulated C-peptide levels at week 78 (0.09 pmol/mL vs. 0.21 pmol/mL; MD -0.13, 95% CI 0.09 to 0.17).
Secondary outcomes
No significant difference in reduction in glycated hemoglobin level at week 78 (-1.98 vs. -1.89; MD -0.09, 95% CI -0.42 to 0.24).
No significant difference in time in the target glucose range at week 78 (67.4% vs. 62.7%; MD 4.71, 95% CI -1.72 to 11.15).
No significant difference in estimated mean daily insulin dose at week 78 (0.46 units/kg/day vs. 0.59 units/kg/day; MD -0.13, 95% CI -0.28 to 0.02).
Safety outcomes
No significant difference in adverse events.
Conclusion
In children and adolescents with newly diagnosed T1DM, teplizumab was superior to placebo with respect to decline in stimulated C-peptide levels at week 78.
Reference
Eleanor L Ramos, Colin M Dayan, Lucienne Chatenoud et al. Teplizumab and β-Cell Function in Newly Diagnosed Type 1 Diabetes. N Engl J Med. 2023 Dec 7;389(23):2151-2161.
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