Teplizumab and β-Cell Function in Newly Diagnosed Type 1 Diabetes
Primary result · Stimulated C-peptideResult — go to the resultLeast-squares mean difference 0.13 pmol per milliliter 95% CI 0.09–0.17Authors' conclusion
Two 12-day courses of teplizumab in children and adolescents with newly diagnosed type 1 diabetes showed benefit with respect to the primary end point of preservation of β-cell function, but no significant differences between the groups were observed with respect to the secondary end points.
Study context
- Population
- Children and adolescents with newly diagnosed T1D
- Participants
- 217 vs 111
- Comparison
- Teplizumab vs placebo, two 12-day courses
- Teplizumabn = 217
- Placebon = 111reference
- Primary endpoint
- Change from baseline in β-cell function (stimulated C-peptide levels)
- Follow-up
- Week 78
Methodological detailsphase 3, placebo-controlled
- Phase 3
- Placebo-controlled
Primary result
Stimulated C-peptide
Least-squares mean difference
0.13 pmol per milliliter
95% CI 0.09–0.17
P < 0.001
Teplizumabvs Placebo
least-squares mean difference 0.13 pmol per milliliter (95% CI 0.09–0.17); P < 0.001
As reported in the abstract
Secondary outcomes
| Outcome | Teplizumab | Placebo |
|---|---|---|
| Maintained clinically meaningful peak C-peptide ≥0.2 pmol/mL | 94.9% (CI 89.5–97.6) | 79.2% (CI 67.7–87.4) |
Key secondary end points: insulin doses, HbA1c, TIR, clinically important hypoglycemic events
- Groups did not differ significantly
Safety
Adverse events
- AEs occurred primarily with administration; included headache, gastrointestinal symptoms, rash, lymphopenia, mild cytokine release syndrome
Original publication
Teplizumab and β-Cell Function in Newly Diagnosed Type 1 Diabetes. N Engl J Med. Published 18 October 2023. doi:10.
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