Table 1—

Baseline characteristics of randomly assigned subjects

Oral insulin groupPlacebo groupP value
n186186
Median age11.0 (7–14)9.5 (7–14)0.3569
Average FPIR (μU/ml)161.6 ± 72.4158.9 ± 99.20.7672
Race0.2807
    White164 (88.1)163 (87.6)
    African American5 (2.6)2 (1.0)
    Hispanic8 (4.3)14 (7.5)
    Other9 (4.7)7 (3.7)
Sex0.1381
    Male119 (63.9)105 (56.4)
    Female67 (36.0)81 (43.5)
Relationship to index patient with diabetes0.6552
    Sibling112 (60.2)108 (58.0)
    Offspring49 (26.3)53 (28.4)
    Parent11 (5.9)7 (3.7)
    Second degree14 (7.5)18 (9.6)
Antibody levels
    Median ICAs (JDF units)80 (403–20)80 (40–160)0.9253
    Mean IAAs (nU/ml)382 ± 555346 ± 4360.4910
GAD antibodies0.2908
    Positive144 (77.8)136 (56.4)
    Negative41 (22.1)50 (43.5)
ICA-512 antibodies0.9567
    Positive97 (52.4)97 (52.1)
    Negative88 (47.5)89 (47.8)
Micro IAA0.0551
    Positive39 (29.3)28 (19.4)
    Negative94 (70.6)116 (80.5)
HbA1c (%)5.35 ± 0.395.33 ± 0.340.5949
C-peptide area under curve
    During intravenous glucose tolerance test34.8 (15.6)35.1 (16.7)0.8800
    During oral glucose tolerance test502.5 (201.1)502.1 (207.2)0.9858
    During mixed meal tolerance test383.1 (172.4)381.0 (183.8)0.9102
  • Data are means ±SD, n (%), or mean (interquartile range).