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type1.science
Phase 2CompletedNCT02846545

T1GER: Golimumab in youth with new-onset type 1 diabetes

Phase 2 trial of the anti-TNF antibody golimumab in children and young adults with new-onset stage-3 T1D. It preserved C-peptide at 52 weeks and reduced insulin use, making anti-TNF one of the missing disease-modifying therapy signals in the prior map.

Primary endpoints

  • 4-hour mixed-meal stimulated C-peptide AUC at week 52

Results so far

Week-52 4-hour C-peptide AUC was 0.64 vs 0.43 pmol/mL with placebo (P<0.001). HbA1c was similar, insulin use was lower, and partial remission was more common with golimumab.

The full picture

T1GER tested whether blocking TNF-alpha could preserve beta-cell function soon after diagnosis. It is not a prevention trial, but it is a meaningful disease-modifying signal that belongs beside abatacept, baricitinib, ustekinumab and imatinib.