Table 1

Characteristics of patients at screening and start of the treatment

VariablePlacebo group (n = 40)ChAglyCD3 (n = 40)P
At screening
 Men26 (65)25 (63)0.816
 Age (years)*26 (7)27 (7)0.596
 Time of insulin treatment (days)6 (2–12)7 (3–14)0.432
 IAA+15 (38)10 (25)0.228
 GADA+37 (93)34 (85)0.288
 IA-2A+21 (53)23 (58)0.653
 ZnT8A+19 (48)20 (50)0.823
 ≥1 autoAb+39 (98)38 (95)0.556
 ≥2 autoAb+28 (70)27 (68)0.809
 IAA levels in IAA+ patients  (% tracer binding)1.3 (0.7–1.9)0.9 (0.7–1.3)0.276
 GADA levels in GADA+ patients  (WHO units/mL)532 (267–3,551)279 (110–1,585)0.088
 IA-2A levels in IA-2A+ patients  (WHO units/mL)271 (93–1,407)620 (95–1,852)0.411
 ZnT8A levels in ZnT8A+ patients  (index)0.17 (0.08–0.38)0.32 (0.10–0.54)0.275
At start of treatment
 Time since diagnosis (days)25 (19–27)21 (18–24)0.113
 Time of insulin treatment (days)20 (13–25)20 (16–24)0.769
 Insulin dose (units ⋅ day−1 ⋅ kg−1)*0.38 (0.20)0.46 (0.27)0.201
 HbA1c (%)*8.1 (1.5)8.6 (1.5)0.059
 HbA1c (mmol/mol)*65 (16)71 (16)
 C-peptide release under glucose  clamping (nmol ⋅ L−1 ⋅ min−1)
  AUC min 60–140*0.61 (0.29)0.54 (0.30)0.160
  • Data are mean (SD)*, n (%), or median (IQR).