Golimumab improves insulin production and blood sugar control in T1D: NEJM

Delhi: Golimumab results in better endogenous insulin production in children and young adults with newly diagnosed overt (stage 3) type 1 diabetes, suggests a recent study in the New England Journal of Medicine.

Type 1 diabetes is an autoimmune disease characterized by progressive loss of pancreatic beta cells that leads to lifelong dependence on insulin therapy. Golimumab is a human monoclonal antibody that is specific for tumor necrosis factor α -- already approved for the treatment of autoimmune conditions in adults and children. However it is unknown if golimumab could preserve beta-cell function in youth with newly diagnosed overt (stage 3) type 1 diabetes. To determine the same, the researchers conducted a phase 2, multicenter, placebo-controlled, double-blind, parallel-group trial. 

The trial included a total of 84 children and young adults (age range, 6 to 21 years) with newly diagnosed overt type 1 diabetes. They were randomized in the ratio 2:1 to receive subcutaneous golimumab (n=56) or placebo (n=28) for 52 weeks.

The primary end point was endogenous insulin production, as assessed according to the area under the concentration–time curve for C-peptide level in response to a 4-hour mixed-meal tolerance test (4-hour C-peptide AUC) at week 52.