TABLE 1.
Characteristics of the study groups
| LDX (N = 50) | Placebo (N = 26) | |
|---|---|---|
| Age (y) | ||
| Mean | 27.6 ± 7.06 | 26.8 ± 6.35 |
| Median | 26 | 26.5 |
| Range | 18‐46 | 18‐38 |
| Male sex (N [%]) | 29 (58) | 16 (61.5) |
| Ethnic group (N [%]) | ||
| White/Caucasian | 49 (98) | 26 (100) |
| No. of autoantibodies (N [%]) | ||
| 1 | 7 (14) | 4 (15.4) |
| 2 | 19 (36) | 7 (26.9) |
| 3 | 13 (28) | 7 (30.8) |
| 4 | 11 (22) | 7 (26.9) |
| IAA+ | 21 (42) | 11 (42.3) |
| GADA | 47 (94) | 23 (88.5) |
| IA‐2A | 28 (56) | 17 (65.4) |
| ZnT8A | 32 (64) | 19 (73.1) |
| No. of days from first insulin to treatment | ||
| Median | 74 | 77 |
| Range a | 29‐104 | 40‐107 |
| Weight (kg) | 68.52 (47.2‐110.4) | 68.27 (44‐109.2) |
| BMI | 22.5 (18.2‐34.5) | 22.7 (18.8‐30.8) |
| White blood cells (cells/mm3) | 5.95 ± 1.54 | 5.77 ± 1.29 |
| Creatinine (μmol/L) | 71.8 ± 13.58 | 66.4 ± 10.91 |
| Creatinine clearance (ml/min) b | 127.3 ± 31.55 | 137.1 ± 35.34 |
| Fasting C‐peptide (nmol/L) | 0.218 ± 0.1087 | 0.225 ± 0.1416 |
| Peak stimulated C‐peptide (nmol/L) | 0.676 ± 0.2708 | 0.675 ± 0.2882 |
| C‐peptide AUC(0‐120) (nmol/L) | 60.381 ± 24.9210 | 59.092 ± 26.243 |
| HbA1c (mmol/mol [%]) | 60 (7.60 ± 1.62) | 50 (7.50 ± 1.37) |
| HbA1c ≥ 7% (N [%]) | 28 (56) | 15 (57.7) |
| Insulin requirement (U/kg/d) | 0.33 ± 0.192 | 0.33 ± 0.198 |
Note. All are means ± SD, unless otherwise specified.
Abbreviations: AUC, area under the curve; BMI, body mass index; GADA, anti‐GAD; IAA, anti‐insulin; IA‐2A, anti‐IA‐2, LDX, ladarixin; ZnT8A, Zinc Transporter 8 antibody.
a
One patient in each treatment group was randomized slightly after 100 days from the first insulin injection (day 103 and day 106 in the LDX e placebo group, respectively); exemption was granted because of patients being already committed to study participation. Such a delay was not considered to impact trial outcome.
b
Cockcroft–Gault formula.