Table 1—

Summary of baseline demographic characteristics of patients with mild-to-moderate DPN

Patient characteristicPlaceboZenarestat 600 mg/dayZenarestat 1,200 mg/day
n472481475
Men276 (58.5)293 (60.9)303 (63.8)
White386 (81.8)395 (82.1)404 (85.1)
Hispanic30 (6.4)33 (6.9)29 (6.1)
Black37 (7.8)29 (6)25 (5.3)
Age (years)51.9 ± 10.352.9 ± 9.852.5 ± 9.7
Type 2 diabetes376 (79.7)399 (83)386 (81.3)
Duration of diabetes (years)10.5 ± 9.4 (0.4–52.6)10.4 ± 10.1 (0.4–60.8)10.3 ± 9.3 (0.4–49)
Alcohol use (no. drinks/week)1.1 ± 2.7 (0–21)1.3 ± 3.2 (0–24)1.4 ± 3.6 (0–42)
HbA1c (%)7.7 ± 1.5 (4.8–11.7)7.8 ± 1.7 (4–12)7.8 ± 1.5 (4–12.4)
 ≤8%275 (62)284 (62)284 (62)
6.7 ± 0.76.8 ± 0.86.9 ± 0.8
 >8%170 (38)176 (38)173 (38)
9.3 ± 0.99.6 ± 0.89.5 ± 1.1
Nerve conduction velocity (m/s)*
n471481475
 Median forearm sensory55.8 ± 4.5 (38.7–75)55.8 ± 4.2 (42.3–69)55.9 ± 4.1 (40.6–67)
 Peroneal motor40.2 ± 4.7 (20–56)40.3 ± 4.5 (16.7–51.3)40.1 ± 4.8 (18.3–54.7)
 Sural sensory41.6 ± 5 (21–56)41.6 ± 5 (29.7–58.3)41.2 ± 5.2 (23–59)
Amplitude (mV)
 Median sensory471481475
22.7 ± 12.4 (3.1–71)22.8 ± 11.8 (4.4–78.2)22.5 ± 11.5 (2.4–66.1)
 Sural sensory470481475
7.4 ± 4 (−6.9 to 22.5)7.5 ± 4.2 (1.3–30)7.5 ± 4 (1.5–26.2)
F-wave latency (m/s)
 Median motor470481473
29.1 ± 2.5 (22.9–36.5)29.1 ± 2.5 (21.6–35.3)29 ± 2.5 (21.9–35.4)
 Peroneal motor402404416
54.6 ± 6.3 (39.4–76.9)55.1 ± 6.3 (38.6–77.8)55.1 ± 6.5 (38.8–81.8)
QST (“just noticeable difference”)*
n471481475
 Cool thermal14.2 ± 4.5 (4.7–25)13.9 ± 4.7 (4.7–25)14.2 ± 4.3 (5.9–25)
 Vibratory19.3 ± 3.2 (7–25)19.7 ± 3.1 (10.3–25)19.5 ± 12.9 (7.8–25)
Neuropathy scores/examination
 MDNS (part 1) (0–30 points)454470465
7.5 ± 4.9 (0–30)8.1 ± 5.2 (0–28)7.6 ± 5 (0–28)
 Monofilament examination 10 g (0–4 points)453469464
1.1 ± 1.3 (0–4)1.1 ± 1.4 (0–4)1.1 ± 1.3 (0–4)
 MNSI (part B) (0–6 points)469479472
2.6 ± 1.6 (0–6)2.7 ± 1.6 (0–6)2.7 ± 1.6 (0–6)
 PNSS (part 2,3) (0–14 points)441448442
3 ± 2.2 (0–14)3.4 ± 2.1 (0–10)3.1 ± 2.1 (0–12)
  • Data are n (%), means ± SD, or means ± SD (range).

  • *

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

  • Sural sensory nerve conduction was mandatory as entrance criteria.

  • Using Computer-Assisted Sensory Examination-IV.