Table 2—

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

EXUSC insulin
n288286
A1C (%)
    Baseline7.4 ± 1.17.5 ± 1.1
    2 years LOCF7.5 ± 1.17.3 ± 1.2
    Change from baseline0.1 ± 0.9−0.2 ± 1.0
    Adjusted treatment difference0.25 ± 0.07 (0.13–0.37)
FPG (mg/dl)
    Baseline170.1 ± 67.2166.9 ± 59.6
    2 years LOCF156.8 ± 77.8173.5 ± 81.0
    Change from baseline−13.3 ± 97.96.6 ± 97.8
    Adjusted treatment difference−17.11 ± 6.60 (−27.98 to −6.23)
Insulin dose
    Short-acting insulin (units)
Baseline22.6 ± 13.323.9 ± 14.4
2 years14.7 ± 9.1*25.4 ± 16.7
    Intermediate-/long-acting insulin (units)
Baseline30.8 ± 13.533.3 ± 15.9
2 years31.8 ± 19.436.2 ± 18.2
Body weight (kg)
    Baseline75.1 ± 13.673.8 ± 13.1
    2 years LOCF75.9 ± 13.675.8 ± 13.8
    Change from baseline0.8 ± 4.22.0 ± 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.