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Table 1—

Patient demographic characteristics at screening (week −4)

EXUSC insulin
n 290 290 
Men/women (%) 169/121 (58/42) 161/129 (56/44) 
Race (%)   
    White 254 (87.6) 261 (90) 
    Black 11 (3.8) 5 (1.7) 
    Asian 1 (0.3) 3 (1.0) 
    Hispanic 19 (6.6) 18 (6.2) 
    Other 5 (1.7) 3 (1.0) 
Age (years) 37.6 ± 11.0 36.5 ± 11.6 
Weight (kg) 74.8 ± 13.6 73.5 ± 13.3 
Height (cm) 172.3 ± 9.7 171.2 ± 10.3 
BMI (kg/m225.1 ± 3.0 25.0 ± 3.1 
A1C (%) 7.8 ± 1.2 7.9 ± 1.2 
C-peptide (pmol/ml) 0.15 ± 0.05 0.15 ± 0.05 
Duration of diabetes (years) 18.4 (1.0–51.8) 17.4 (1.0–48.7) 
FEV1*   
    Observed (l) 3.50 ± 0.76 3.47 ± 0.77 
    Predicted (%) 93.1 ± 10.8 93.2 ± 10.5 
DLCO*   
    Observed (ml · min−1 · mmHg−128.09 ± 6.22 27.20 ± 6.41 
    Predicted (%) 94.7 ± 13.2 92.2 ± 12.6 
EXUSC insulin
n 290 290 
Men/women (%) 169/121 (58/42) 161/129 (56/44) 
Race (%)   
    White 254 (87.6) 261 (90) 
    Black 11 (3.8) 5 (1.7) 
    Asian 1 (0.3) 3 (1.0) 
    Hispanic 19 (6.6) 18 (6.2) 
    Other 5 (1.7) 3 (1.0) 
Age (years) 37.6 ± 11.0 36.5 ± 11.6 
Weight (kg) 74.8 ± 13.6 73.5 ± 13.3 
Height (cm) 172.3 ± 9.7 171.2 ± 10.3 
BMI (kg/m225.1 ± 3.0 25.0 ± 3.1 
A1C (%) 7.8 ± 1.2 7.9 ± 1.2 
C-peptide (pmol/ml) 0.15 ± 0.05 0.15 ± 0.05 
Duration of diabetes (years) 18.4 (1.0–51.8) 17.4 (1.0–48.7) 
FEV1*   
    Observed (l) 3.50 ± 0.76 3.47 ± 0.77 
    Predicted (%) 93.1 ± 10.8 93.2 ± 10.5 
DLCO*   
    Observed (ml · min−1 · mmHg−128.09 ± 6.22 27.20 ± 6.41 
    Predicted (%) 94.7 ± 13.2 92.2 ± 12.6 

Data are means ± SD (range) unless otherwise indicated.

*

FEV1 and DLCO test values at study entry were defined as the means of the values obtained before the first dose of study drug after randomization.

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