Table 1 Baseline participant characteristics
Parameter | GABA n = 39 | GABA/GAD n = 22 | Placebo n = 30 | GABA vrs placebo | GABA/GAD vrs placebo |
|---|---|---|---|---|---|
Age, years | 11.2 ± 3.9 | 11.6 ± 3.2 | 11.1 ± 3.5 | 0.887 | 0.594 |
4–8 yrs (%) | 31% | 32% | 30% | 0.633 | 0.814 |
9–11 yrs(%) | 44% | 45% | 53% | ||
14–18 yrs (%) | 26% | 23% | 17% | ||
Sex Male %(n) | 54%(21) | 64%(14) | 43%(13) | 0.470 | 0.171 |
Female %(n) | 46%(18) | 36%(8) | 57%(17) | ||
BMI (kg/m2) | 19.6 ± 3.4 | 19.3 ± 3.4 | 19.0 ± 3.2 | 0.435 | 0.770 |
BMI percentile | 66.9 ± 29.1 | 61.4 ± 26.5 | 60.3 ± 28.1 | 0.343 | 0.886 |
Ethnicity %(n) | |||||
White | 92.3% (36) | 90.9% (20) | 86.7% (26) | 0.387 | 0.650 |
African American | 5.1% (2) | 9.1% (2) | 6.7% (2) | ||
Hispanic | 0 | 0 | 6.7% (2) | ||
Native American | 2.6% (1) | 0 | 0 | ||
Days from diagnosis to baseline visit | 25.3 ± 7.2 | 26.6 ± 6.3 | 25.8 ± 8.2 | 0.821 | 0.678 |
Diabetes ketoacidosis at diagnosis %(n) | 23.0% (9) | 22.7% (5) | 36.6% (11) | 0.287 | 0.368 |
Diabetes autoantibodies (% positive)a | |||||
Anti-ICA 512 | 81% | 87% | 83% | 0.814 | 1.000 |
Anti-Zinc Transporter-8 | 94% | 74% | 87% | 0.407 | 0.282 |
Number of autoantibodies positive (% patients) | |||||
1 | 3.9% | 7.1% | 8.3% | 0.862 | |
2 | 34.6% | 28.6% | 20.8% | 0.503 | |
3 | 61.5% | 64.3% | 70.8% | ||
HbA1C % | 11.0 ± 2.5 | 10.4 ± 2.2 | 11.1 ± 2.5 | 0.982 | 0.349 |
Total Daily Dose insulin (units/kg/day) | 0.56 ± 0.21 | 0.47 ± 0.24 | 0.56 ± 0.21 | 0.984 | 0.167 |
C-peptide AUC at baseline (ng/ml/min) | 1.85 ± 1.21 | 2.13 ± 1.16 | 1.87 ± 1.3 | 0.883 | 0.533 |
C-peptide fasting at baseline (ng/ml) | 0.74 ± 0.55 | 0.78 ± 0.48 | 0.72 ± 0.60 | 0.884 | 0.630 |
Glucagon AUC at baseline (pg/ml/min) | 78.05 ± 26.35 | 70.73 ± 24.51 | 77.90 ± 16.87 | 0.933 | 0.278 |
Glucagon fasting at baseline (pg/ml) | 65.35 ± 16.10 | 61.11 ± 16.56 | 62.62 ± 13.62 | 0.906 | 0.770 |
