Baseline characteristics of randomly assigned subjects
| Oral insulin group | Placebo group | P value | |
|---|---|---|---|
| n | 186 | 186 | |
| Median age | 11.0 (7–14) | 9.5 (7–14) | 0.3569 |
| Average FPIR (μU/ml) | 161.6 ± 72.4 | 158.9 ± 99.2 | 0.7672 |
| Race | 0.2807 | ||
| White | 164 (88.1) | 163 (87.6) | |
| African American | 5 (2.6) | 2 (1.0) | |
| Hispanic | 8 (4.3) | 14 (7.5) | |
| Other | 9 (4.7) | 7 (3.7) | |
| Sex | 0.1381 | ||
| Male | 119 (63.9) | 105 (56.4) | |
| Female | 67 (36.0) | 81 (43.5) | |
| Relationship to index patient with diabetes | 0.6552 | ||
| Sibling | 112 (60.2) | 108 (58.0) | |
| Offspring | 49 (26.3) | 53 (28.4) | |
| Parent | 11 (5.9) | 7 (3.7) | |
| Second degree | 14 (7.5) | 18 (9.6) | |
| Antibody levels | |||
| Median ICAs (JDF units) | 80 (403–20) | 80 (40–160) | 0.9253 |
| Mean IAAs (nU/ml) | 382 ± 555 | 346 ± 436 | 0.4910 |
| GAD antibodies | 0.2908 | ||
| Positive | 144 (77.8) | 136 (56.4) | |
| Negative | 41 (22.1) | 50 (43.5) | |
| ICA-512 antibodies | 0.9567 | ||
| Positive | 97 (52.4) | 97 (52.1) | |
| Negative | 88 (47.5) | 89 (47.8) | |
| Micro IAA | 0.0551 | ||
| Positive | 39 (29.3) | 28 (19.4) | |
| Negative | 94 (70.6) | 116 (80.5) | |
| HbA1c (%) | 5.35 ± 0.39 | 5.33 ± 0.34 | 0.5949 |
| C-peptide area under curve | |||
| During intravenous glucose tolerance test | 34.8 (15.6) | 35.1 (16.7) | 0.8800 |
| During oral glucose tolerance test | 502.5 (201.1) | 502.1 (207.2) | 0.9858 |
| During mixed meal tolerance test | 383.1 (172.4) | 381.0 (183.8) | 0.9102 |
Data are means ±SD, n (%), or mean (interquartile range).