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 |
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.