Table 2—

Changes in A1C, FPG, insulin dose, and body weight from baseline (week 0)

EXUSubcutaneous insulin
n314303
A1C (%)
    Baseline7.66 ± 1.127.77 ± 1.11
    2 years LOCF7.33 ± 1.317.32 ± 1.22
    Change from baseline−0.33 ± 1.04−0.45 ± 1.13
    Adjusted treatment difference0.09 (−0.04 to 0.23)
FPG (mg/dl)
    Baseline151.2 ± 44.6148.2 ± 46.1
    2 years LOCF135.6 ± 53.4147.1 ± 61.3
    Change from baseline−15.67 ± 57.31−1.06 ± 68.04
    Adjusted treatment difference−12.4 (−19.7 to −5.0)
Average daily insulin dose
    Short-acting insulin (units)
Baseline27.4 ± 19.626.9 ± 16.0
2 years15.8 ± 10.2*34.6 ± 21.8
    Intermediate-/long-acting insulin (units)
Baseline43.2 ± 22.244.0 ± 22.9
2 years46.4 ± 28.550.0 ± 29.1
Body weight (kg)
    Baseline87.1 ± 14.888.4 ± 15.4
    2 years LOCF88.8 ± 15.391.4 ± 16.2
    Change from baseline1.7 ± 4.73.0 ± 5.2
    Adjusted treatment difference−1.3 (−1.9 to −0.7)
  • Data are means ± SD or means (90% CI). Baseline A1C, FPG, and body weight were defined as the average of all measurements after the screening date and prior to the first dose of study drug after randomization. The baseline insulin dose was the week 0 dose of subcutaneous insulin.

  • * During the comparative phase, the short-acting insulin was EXU and was measured in milligrams; 1 mg is equivalent to ∼2–3 units of subcutaneously injected fast-acting human insulin.