Table 1— Neurophysiological and neurological results at baseline and change from baseline to 6 months of treatment

Baseline Change from baseline

Placebo Active combined C-peptide

Low dose High dose

n 139 47 92 53 30
Neurographic variables
    SCVp (m/s) 35.4 ± 0.31 0.24 ± 0.27 0.48 ± 0.19{dagger} 0.38 ± 0.27 0.63 ± 0.26*
    SCVi (m/s) 44.2 ± 0.41 0.75 ± 0.38 0.93 ± 0.29{dagger} 0.77 ± 0.43* 1.14 ± 0.36{dagger}
    MCV (m/s) 40.0 ± 0.41* –0.53 ± 0.22* –0.38 ± 0.15* –0.25 ± 0.19 –0.57 ± 0.24*
VPT
    z-VPT foot 1.9 ± 0.12 0.03 ± 0.13 –0.09 ± 0.07 –0.07 ± 0.09 –0.12 ± 0.11
    z-VPT lower leg 0.6 ± 0.10 –0.09 ± 0.08 –0.19 ± 0.06{dagger} –0.18 ± 0.06* –0.22 ± 0.13{ddagger}
Neurological examination
    NIA score (points) 18.0 ± 0.86 –0.9 ± 0.94 –2.2 ± 0.78{dagger} –1.7 ± 0.97 –2.7 ± 1.31*

Data are means ± SE. Improvements for VPTs and the neurological assessment are indicated as negative differences. z indicates that the variable is expressed as a z-score, i.e., deviation from the corresponding reference value expressed in SD.

*P < 0.05,

{dagger}P < 0.01, and

{ddagger}P = 0.057 for differences within groups compared with baseline.