Table 1—

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

BaselineChange from baseline
PlaceboActive combinedC-peptide
Low doseHigh dose
n13947925330
Neurographic variables
    SCVp (m/s)35.4 ± 0.310.24 ± 0.270.48 ± 0.190.38 ± 0.270.63 ± 0.26*
    SCVi (m/s)44.2 ± 0.410.75 ± 0.380.93 ± 0.290.77 ± 0.43*1.14 ± 0.36
    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 foot1.9 ± 0.120.03 ± 0.13−0.09 ± 0.07−0.07 ± 0.09−0.12 ± 0.11
    z-VPT lower leg0.6 ± 0.10−0.09 ± 0.08−0.19 ± 0.06−0.18 ± 0.06*−0.22 ± 0.13
Neurological examination
    NIA score (points)18.0 ± 0.86−0.9 ± 0.94−2.2 ± 0.78−1.7 ± 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,

  • P < 0.01, and

  • P = 0.057 for differences within groups compared with baseline.