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. 2016 Jan 4;101(3):988–998. doi: 10.1210/jc.2015-1991

Table 3.

Statistical Analysis of PD End Points (IGF-1 and IGFBP-3) After Multiple Doses of NNC0195-0092 Compared With Daily Norditropin NordiFlex

Dose Level, mg/kga Estimated Mean Ratio AUC0–168h 95% CI P Value Estimated Mean Ratio Cmax 95% CI P Value
IGF-1
    0.02 mg/kg/Norditropin NordiFlex 0.87 [0.66, 1.13] .2713 0.95 [0.72, 1.24] .6896
    0.04 mg/kg/Norditropin NordiFlex 1.08 [0.82, 1.43] .5719 1.13 [0.85, 1.50] .3940
    0.08 mg/kg/Norditropin NordiFlex 1.37 [1.04, 1.82] .0275 1.48 [1.12, 1.97] .0086
    0.12 mg/kg/Norditropin NordiFlex 2.32 [1.77, 3.04] <.0001 2.52 [1.92, 3.32] <.0001
IGFBP-3
    0.02 mg/kg/Norditropin NordiFlex 0.92 [0.84, 1.01] .0929 0.98 [0.88, 1.09] .6646
    0.04 mg/kg/Norditropin NordiFlex 1.01 [0.91, 1.12] .8380 1.03 [0.92, 1.15] .5697
    0.08 mg/kg/Norditropin NordiFlex 1.02 [0.93, 1.13] .6460 1.04 [0.93, 1.16] .5043
    0.12 mg/kg/Norditropin NordiFlex 1.19 [1.08, 1.31] .0010 1.19 [1.06, 1.32] .0031

Abbreviation: CI, confidence interval.

a

Assessments at dose 4 for NNC0195-0092 and at week 4/day 22 for Norditropin NordiFlex.