Table 1 Baseline patient and disease characteristics — safety analysis set

Age, years, mean ± SD

24.3 ± 3.37

22.2 ± 3.19

24.4 ± 4.53

24.2 ± 4.25

24.0 ± 3.91

Females:males^a

5:5

2:4

2:7

4:12

13:28

BMI, kg/m², mean ± SD

24.2 ± 2.73

23.3 ± 2.86

22.7 ± 2.56

22.9 ± 3.33

23.2 ± 2.92

Glycemic parameters at baseline, mean ± SD

 MMTT: C-peptide C_max, nmol/L

0.867 ± 0.2

0.65 ± 0.221

0.873 ± 0.342

0.781 ± 0.251

0.803 ± 0.261

 MMTT: Glucose at start, mmol/L

6.9 ± 1.19

7.9 ± 1.63

6.2 ± 1.24

7.0 ± 1.21

6.9 ± 1.33

 MMTT: C-peptide normalized AUC, nmol/L

0.694 ± 0.218

0.515 ± 0.157

0.672 ± 0.278

0.585 ± 0.179

0.621 ± 0.213

 Blood glucose, mmol/L^b

7.06 ± 1.49

8.11 ± 1.29

6.7 ± 1.17

7.5 ± 1.47

7.31 ± 1.41

 C-peptide/glucose ratio, nmol/mol^b

49.9 ± 16.4

36.2 ± 14.5

54.9 ± 23.6

43.7 ± 11.6

46.6 ± 16.9

 HbA1c, mmol/L

7.18 ± 1.299

7.45 ± 0.841

6.87 ± 1.442

6.72 ± 0.810

6.98 ± 1.108

Number of autoantibodies against GAD65, IA-2, or ZnT8, n (%)^a

 1

4 (40.0)

1 (16.7)

1 (11.1)

2 (12.5)

8 (19.5)

 2

3 (30.0)

0 (0.0)

3 (33.3)

5 (31.2)

11 (26.8)

 3

3 (30.0)

5 (83.3)

5 (55.6)

9 (56.3)

22 (53.7)

Autoantibodies against insulin, n (%)

5 (50.0)

1 (16.7)

4 (44.4)

10 (62.5)

20 (48.8)

Time from diagnosis to first dose, days, mean ± SD

112 ± 51

106 ± 55

102 ± 52

116 ± 46

110 ± 49

HLA status, n (%)^a

 DR3⁺/DR4⁻

2 (20.0)

2 (33.3)

1 (11.1)

5 (31.2)

10 (24.4)

 DR4⁺/DR3⁻

2 (20.0)

3 (50.0)

6 (66.7)

8 (50.0)

19 (46.3)

 DR3⁺/DR4⁺

6 (60.0)

1 (16.7)

2 (22.2)

3 (18.8)

12 (29.3)