Preserving beta cell function in children and adolescents with newly diagnosed stage 3 type 1 diabetes: per-protocol population analysis from the PROTECT randomised trial
Primary result · Change in stimulated C-peptide from baselineResult — go to the resultLS mean difference 0.14 nmol/l 95% CI 0.10–0.18Authors' conclusion
Teplizumab treatment per protocol led to greater beta cell function preservation, greater TIR and lower exogenous insulin use compared with placebo. Beta cell function preservation was maintained irrespective of HLA subtype or the presence of type 1 diabetes autoantibodies.
Study context
- Population
- Participants aged 8–17 years with stage 3 T1D and peak stimulated C-peptide ≥0.2 nmol/lPer-protocol (PP) population
- Participants
- 275 participants
- Comparison
- Teplizumab vs placebo
- Teplizumabn = 180
- Placebon = 95reference
- Primary endpoint
- LS mean difference in change of stimulated C-peptide from baseline
- Follow-up
- Week 78
Methodological detailspre-specified per-protocol population analysis, placebo-controlled
- Pre-specified per-protocol population analysis
- Placebo-controlled
Primary result
Change in stimulated C-peptide from baseline
Least squares (LS) mean difference
0.14 nmol/l
95% CI 0.10–0.18
P < 0.001
Teplizumabvs Placebo
LS mean difference 0.14 nmol/l (95% CI 0.10–0.18); P < 0.001
As reported in the abstract
Further findings
| Outcome | LS mean difference (U kg-1 day-1) (95% CI) | P value | |
|---|---|---|---|
| Exogenous insulin dose · week 78 | −0.17 (−0.26 to −0.08) | P < 0.001 | |
| −0.4−0.200.2Difference, U kg-1 day-1 (linear scale) |
| Outcome | LS mean difference (%) (95% CI) | P value | |
|---|---|---|---|
| TIR · week 78 | 6.17 (0.13–12.2) | P < 0.05 | |
| −5051015Difference, % (linear scale) |
C-peptide by HLA-DR3/HLA-DR4 and baseline T1D autoantibody subgroups
- Higher C-peptide with teplizumab vs placebo regardless of HLA-DR3/HLA-DR4 presence or baseline T1D autoantibodies
Original publication
Preserving beta cell function in children and adolescents with newly diagnosed stage 3 type 1 diabetes: per-protocol population analysis from the PROTECT randomised trial. Diabetologia. Published 10 September 2026. doi:10.
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