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† | 0.38 ± 0.27 | 0.63 ± 0.26* | |||
| SCVi (m/s) | 44.2 ± 0.41 | 0.75 ± 0.38 | 0.93 ± 0.29† | 0.77 ± 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 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† | −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.