Golimumab and Beta-Cell Function in Youth with New-Onset Type 1 Diabetes

This phase 2 trial evaluated the efficacy of golimumab, a TNF-α inhibitor, in preserving beta  cell function in youth (ages 6–21) with newly diagnosed type 1 diabetes. Participants (N=84) were randomized 2:1 to receive golimumab or placebo for 52 weeks. The primary endpoint was endogenous insulin production, measured by C peptide AUC during a mixed meal tolerance test. At week 52, the golimumab group showed significantly higher C peptide AUC (0.64±0.42 pmol/mL vs. 0.43±0.39 pmol/mL, P<0.001) and required less exogenous insulin. A partial remission response (insulin dose-adjusted HbA1c ≤9) was observed in 43% of golimumab recipients versus 7% with placebo. Safety profiles were similar between groups, with no severe infections. Golimumab may slow beta-cell decline in early-stage type 1 diabetes.

This phase 2 trial evaluated the efficacy of golimumab, a TNF-α inhibitor, in preserving beta  cell function in youth (ages 6–21) with newly diagnosed type 1 diabetes. Participants (N=84) were randomized 2:1 to receive golimumab or placebo for 52 weeks. The primary endpoint was endogenous insulin production, measured by C peptide AUC during a mixed meal tolerance test. At week 52, the golimumab group showed significantly higher C peptide AUC (0.64±0.42 pmol/mL vs. 0.43±0.39 pmol/mL, P<0.001) and required less exogenous insulin. A partial remission response (insulin dose-adjusted HbA1c ≤9) was observed in 43% of golimumab recipients versus 7% with placebo. Safety profiles were similar between groups, with no severe infections. Golimumab may slow beta-cell decline in early-stage type 1 diabetes.