Table 4—

Summary of changes from baseline in the zenarestat-treated patients

MeasurePlaceboZenarestat 600 mg/dayZenarestat 1,200 mg/day
n472481475
Nerve conduction velocity (ms)*
 Median forearm sensory360371324
−0.05 ± 3.40.8 ± 2.9‡0.8 ± 2.9‡
  HbA1c ≤8%216218194
−0.13 ± 3.30.62 ± 30.79 ± 2.9
  HbA1c >8%122139115
−0.06 ± 3.70.93 ± 2.71 ± 3
 Peroneal motor359372324
−0.21 ± 2.20.72 ± 2.3‡0.81 ± 2.1‡
  HbA1c ≤8%216219194
−0.20 ± 2.20.77 ± 2.40.71 ± 2
  HbA1c >8%121139115
−0.21 ± 2.10.66 ± 2.11.1 ± 2.1
 Sural sensory†357371324
−0.7 ± 3.7‡0.06 ± 4−0.02 ± 4
  HbA1c ≤8%216218194
−0.61 ± 3.70.20 ± 3.90.29 ± 4.1
  HbA1c >8%119139115
−0.68 ± 3.4−0.07 ± 40.54 ± 3.6
Amplitude (mV)
 Median sensory amplitude359371324
−0.8 ± 4.9‡−0.38 ± 4.5−0.2 ± 4
  HbA1c ≤8%216218194
−0.59 ± 5.2−0.12 ± 4.4−0.03 ± 4
  HbA1c >8%119139115
−1.03 ± 4.4−0.82 ± 4.7−0.57 ± 4
 Sural sensory amplitude355371323
−0.3 ± 3.1−0.44 ± 2.4‡−0.59 ± 2.7‡
  HbA1c ≤8%214218194
−0.16 ± 2.7−0.34 ± 2.4−0.59 ± 2.7
  HbA1c >8%119139114
−0.44 ± 3.9−0.53 ± 2.4−0.40 ± 2.3
F-wave latency (ms)
 Median motor355370320
0.2 ± 0.9‡−0.06 ± 10.02 ± 1
  HbA1c ≤8%214217§193
0.18 ± 0.90.10 ± 0.90.07 ± 1.0
  HbA1c >8%119139114
0.15 ± 1−0.24 ± 1.0§−0.06 ± 0.9
 Peroneal motor276277254
0.3 ± 3.1−0.13 ± 2.9−0.34 ± 2.9
  HbA1c ≤8%170162156
0.48 ± 3.3−0.08 ± 3.2−0.25 ± 2.8
  HbA1c >8%9210385
0.15 ± 2.9−0.16 ± 2.1−0.37 ± 3
QST (“just noticeable difference”)*‖
 Cool thermal360373327
0.6 ± 3.3‡0.6 ± 3.2‡0.5 ± 3‡
  HbA1c ≤8%217220196
0.40 ± 3.40.42 ± 3.20.20 ± 2.9§
  HbA1c >8%121139116
0.98 ± 3.10.99 ± 3.10.98 ± 3.2§
 Vibration359374326
0.07 ± 1.70.2 ± 1.70.3 ± 1.7‡
  HbA1c ≤8%216221196
−0.02 ± 1.60.14 ± 1.70.13 ± 1.6§
  HbA1c >8%121139115
0.27 ± 1.80.22 ± 1.60.54 ± 1.9§

  • Data are means ± SD.

  • *

    ↵* No response values had a value imputed. See text for details.

  • †

    ↵† Sural sensory nerve conduction was mandatory as entrance criteria.

  • ‡

    ↵‡ Statistically significant change from baseline at P < 0.05.

  • §

    ↵§ Statistically significant change from baseline between HbA1c strata at P < 0.05.

  • ‖

    ↵‖ QST using Computer-Assisted Sensory Examination-IV.