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Table 2—

Changes in A1C, fasting plasma glucose, insulin dose, and body weight from baseline (week 0)

EXUSC insulin
n 288 286 
A1C (%)   
    Baseline 7.4 ± 1.1 7.5 ± 1.1 
    2 years LOCF 7.5 ± 1.1 7.3 ± 1.2 
    Change from baseline 0.1 ± 0.9 −0.2 ± 1.0 
    Adjusted treatment difference 0.25 ± 0.07 (0.13–0.37)  
FPG (mg/dl)   
    Baseline 170.1 ± 67.2 166.9 ± 59.6 
    2 years LOCF 156.8 ± 77.8 173.5 ± 81.0 
    Change from baseline −13.3 ± 97.9 6.6 ± 97.8 
    Adjusted treatment difference −17.11 ± 6.60 (−27.98 to −6.23)  
Insulin dose   
    Short-acting insulin (units)   
Baseline 22.6 ± 13.3 23.9 ± 14.4 
2 years 14.7 ± 9.1* 25.4 ± 16.7 
    Intermediate-/long-acting insulin (units)   
Baseline 30.8 ± 13.5 33.3 ± 15.9 
2 years 31.8 ± 19.4 36.2 ± 18.2 
Body weight (kg)   
    Baseline 75.1 ± 13.6 73.8 ± 13.1 
    2 years LOCF 75.9 ± 13.6 75.8 ± 13.8 
    Change from baseline 0.8 ± 4.2 2.0 ± 4.6 
    Adjusted treatment difference −1.25 ± 0.36 (−1.85 to −0.66)  
EXUSC insulin
n 288 286 
A1C (%)   
    Baseline 7.4 ± 1.1 7.5 ± 1.1 
    2 years LOCF 7.5 ± 1.1 7.3 ± 1.2 
    Change from baseline 0.1 ± 0.9 −0.2 ± 1.0 
    Adjusted treatment difference 0.25 ± 0.07 (0.13–0.37)  
FPG (mg/dl)   
    Baseline 170.1 ± 67.2 166.9 ± 59.6 
    2 years LOCF 156.8 ± 77.8 173.5 ± 81.0 
    Change from baseline −13.3 ± 97.9 6.6 ± 97.8 
    Adjusted treatment difference −17.11 ± 6.60 (−27.98 to −6.23)  
Insulin dose   
    Short-acting insulin (units)   
Baseline 22.6 ± 13.3 23.9 ± 14.4 
2 years 14.7 ± 9.1* 25.4 ± 16.7 
    Intermediate-/long-acting insulin (units)   
Baseline 30.8 ± 13.5 33.3 ± 15.9 
2 years 31.8 ± 19.4 36.2 ± 18.2 
Body weight (kg)   
    Baseline 75.1 ± 13.6 73.8 ± 13.1 
    2 years LOCF 75.9 ± 13.6 75.8 ± 13.8 
    Change from baseline 0.8 ± 4.2 2.0 ± 4.6 
    Adjusted treatment difference −1.25 ± 0.36 (−1.85 to −0.66)  

Data are presented as means ± SD or adjusted mean ± SEM (95% CI).

*

During the comparative phase, EXU was measured in milligrams; 1 mg is equivalent approximately to 2–3 units of subcutaneously injected fast-acting human insulin. Baseline A1C, FPG, and body weight were defined as the average of all measurements after the screening date and before the first dose of the study drug after randomization. Baseline insulin dose was the week 0 measurement.

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