Overview
- Researchers tested anti‑thymocyte globulin (ATG) in a multicentre, double‑blind, randomized, placebo‑controlled, adaptive dose‑ranging study across 14 hospitals in eight European countries.
- ATG was infused over two consecutive days, with participants aged 5–25 years randomized to placebo, 0.5 mg/kg, or 2.5 mg/kg after lower and intermediate doses were dropped per protocol.
- The primary endpoint—stimulated C‑peptide area under the curve at 12 months—showed that 0.5 mg/kg preserved beta‑cell function comparably to 2.5 mg/kg versus placebo.
- Safety favored the lower dose: cytokine release syndrome occurred in 33% at 2.5 mg/kg versus 24% at 0.5 mg/kg, and serum sickness in 82% versus 32%, with none in the placebo group.
- Investigators recommend 0.5 mg/kg for young patients, noting it can be given as a single‑day infusion and is widely available at affordable prices; results were published in The Lancet and presented at EASD.