ATG 2.5 and 0.5 mg/kg reduces loss of β-cell function in young people with recent-onset type 1 diabetes
MONDAY, Sept. 29, 2025 (HealthDay News) — Antithymocyte globulin (ATG) 2.5 and 0.5 mg/kg reduces loss of β-cell function in young people with recent-onset type 1 diabetes, according to a study published online Sept. 18 in The Lancet to coincide with the annual meeting of the European Association for the Study of Diabetes, held from Sept. 15 to 19 in Vienna.
Chantal Mathieu, M.D., from UZ Leuven in Belgium, and colleagues conducted a phase 2, placebo-controlled trial in 14 trial centers in eight countries involving participants aged 5 to 25 years diagnosed with clinical, stage 3 type 1 diabetes three to nine weeks before treatment. Participants were randomly assigned to receive placebo, 2.5 mg/kg ATG, 1.5 mg/kg ATG, 0.5 mg/kg ATG, or 0.1 mg/kg ATG (31, 33, 12, 35, and six participants, respectively). The 0.1- and 1.5-mg/kg doses were progressively dropped from the study.
The researchers found that the area under the curve (AUC) of the stimulated C-peptide concentration during a two-hour mixed-meal tolerance test at 12 months, measured as ln(AUC C-peptide+1), was 0.411 and 0.535 nmol/L per minute in the placebo group and ATG 2.5-mg/kg group, respectively (mean difference, 0.124 nmol/L per min). In the ATG 0.5-mg/kg group, the ln(AUC C-peptide+1) was 0.513 nmol/L per minute at 12 months, with a mean baseline-adjusted difference from placebo of 0.102 nmol/L per minute. Cytokine release syndrome occurred in 33 and 24 percent of participants in the ATG 2.5- and 0.5-mg/kg groups, respectively, and in no participants in the placebo group.
“It should be noted that the ATG therapy at 0.5 mg/kg as a single-day infusion is available in most countries worldwide at very affordable prices,” Mathieu said in a statement.
Several authors disclosed ties to the biopharmaceutical and medical technology industries.
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