3-LB: Golimumab (GLM) Preserves ß-Cell Function and Reduces Insulin Use and Hypoglycemia in Children and Young Adults with Recently Diagnosed Type 1 Diabetes (T1D): The Phase 2 T1GER Study

Abstract

T1D is an autoimmune disease characterized by progressive loss of pancreatic β cells. GLM is a human IgG1κ monoclonal antibody specific for tumor necrosis factor α. This study assessed whether GLM preserves β-cell function in children and young adults with newly diagnosed stage 3 T1D. This Phase 2a, double-blind, placebo (PBO)-controlled study randomized participants aged 6-21 yrs with newly diagnosed stage 3 T1D to receive subcutaneous GLM (BSA-based dose if <45 kg; fixed dose if ≥45 kg) or PBO (2:1) for 52 weeks. The primary endpoint was C-peptide area under the curve (AUC) at Week 52 after a 4-hour mixed-meal tolerance test. Insulin use, HbA1c, hypoglycemia rates, and proinsulin/C-peptide ratios were assessed. 84 participants were enrolled (GLM, n = 56; PBO, n = 28). The study was positive as mean (SD) 4-hour C-peptide AUC at Week 52 was 0.64 (0.423) and 0.43 (0.388) pmol/mL with GLM and PBO, respectively (P<0.001; Figure). GLM-treated participants had lower insulin use, hypoglycemia rates, and proinsulin/C-peptide ratios vs. PBO. Both groups maintained good glycemic control. GLM was well tolerated, without any new safety signals. In this study, golimumab demonstrated the ability to preserve endogenous insulin production and improve clinical and metabolic parameters in children and young adults with newly diagnosed stage 3 T1D. Disclosure T. Quattrin: Consultant; Self; Janssen Pharmaceuticals, Inc. Research Support; Self; Janssen Pharmaceuticals, Inc., Provention Bio, Inc. M.J. Haller: Advisory Panel; Self; SAB Biotherapeutics, Inc. A. Steck: None. E. Felner: None. Y. Li: Employee; Self; Janssen Research & Development, LLC. K. Xia: Employee; Self; Janssen Research & Development, LLC. J. Leu: Employee; Self; Janssen Research & Development, LLC. M. Rigby: None. R. Zoka: Employee; Self; Janssen Research & Development, LLC. J. Hedrick: Employee; Self; Janssen Pharmaceuticals, Inc. F. Vercruysse: Employee; Self; Janssen Pharmaceuticals, Inc. Stock/Shareholder; Self; Johnson & Johnson. Funding Janssen Research & Development, LLC