Table 1—

Results and ANOVA comparisons of BIAsp 30 (injected at mealtime) with Mix25 (injected at mealtime) and BHI 30 (injected 15 min before mealtime)legend

Glucose end pointMeans ± SDRatio* between treatments (95% CI)
BIAsp 30 / BHI 30BIAsp 30 / Mix25
Pharmacodynamic end points: Glucose excursion
    EXC0–5 (SG) (mmol/l × h)
        BHI 3020.1 ± 4.90.83 (0.77; 0.90)
        BIAsp 3016.6 ± 4.40.90 (0.83; 0.98)
        Mix2518.9 ± 6.1
    EXC0–2 (SG) (mmol/l × h)
        BHI 309.4 ± 2.70.81 (0.71; 0.93)§
        BIAsp 307.7 ± 2.70.97 (0.85; 1.11)
        Mix258.5 ± 3.3
    EXC2–5 (SG) (mmol/l × h)
        BHI 3010.1 ± 3.20.82 (0.72; 0.94)§
        BIAsp 308.3 ± 2.60.88 (0.77; 1.00)
        Mix259.7 ± 3.8
    Cmax (SG) (mmol/l)
        BHI 3016.7 ± 2.60.95 (0.91; 1.00)
        BIAsp 3015.9 ± 2.70.99 (0.94; 1.04)
        Mix2516.4 ± 3.2
    tmax (SG) (min)
        BHI 3088.0 ± 26.4−13.2 (−22.2; −4.1)§
        BIAsp 3075.1 ± 22.2−11.3 (−20.5; −2.11)
        Mix2586.5 ± 26.9
Pharmacokinetic end points: Insulin
    AUC0–5h (ins) (pmol/l × h)
        BHI 30741 ± 4261.72 (1.40; 2.10)
        BIAsp 301,079 ± 5351.07 (0.90; 1.28)
        Mix251,031 ± 621
    Cmax (ins) (pmol/l)
        BHI 30237 ± 1562.01 (1.64; 2.46)
        BIAsp 30415 ± 2441.12 (0.95; 1.34)
        Mix25360 ± 211
    tmax (ins) (min)
        BHI 30169 ± 71−55.3 (−85.0; −25.5)
        BIAsp 30115 ± 5915.15 (−11.4; 41.7)
        Mix25100 ± 41
  • legend

    legend PK and PD parameter data are means ± SD. The ratios and differences (with 95% CIs) refer to ANOVA analyses comparing BIAsp 30 with Mix25 and BHI 30 treatments in the PP population.

  • *

    * Ratios except for tmax are difference in minutes;

  • P < 0.001;

  • P < 0.05;

  • §

    § P < 0.01;

  • data obtained from t = −15 to t =285.