Summary of baseline demographic characteristics of patients with mild-to-moderate DPN
| Patient characteristic | Placebo | Zenarestat 600 mg/day | Zenarestat 1,200 mg/day |
|---|---|---|---|
| n | 472 | 481 | 475 |
| Men | 276 (58.5) | 293 (60.9) | 303 (63.8) |
| White | 386 (81.8) | 395 (82.1) | 404 (85.1) |
| Hispanic | 30 (6.4) | 33 (6.9) | 29 (6.1) |
| Black | 37 (7.8) | 29 (6) | 25 (5.3) |
| Age (years) | 51.9 ± 10.3 | 52.9 ± 9.8 | 52.5 ± 9.7 |
| Type 2 diabetes | 376 (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 ± 0.7 | 6.8 ± 0.8 | 6.9 ± 0.8 | |
| >8% | 170 (38) | 176 (38) | 173 (38) |
| 9.3 ± 0.9 | 9.6 ± 0.8 | 9.5 ± 1.1 | |
| Nerve conduction velocity (m/s)* | |||
| n | 471 | 481 | 475 |
| Median forearm sensory | 55.8 ± 4.5 (38.7–75) | 55.8 ± 4.2 (42.3–69) | 55.9 ± 4.1 (40.6–67) |
| Peroneal motor | 40.2 ± 4.7 (20–56) | 40.3 ± 4.5 (16.7–51.3) | 40.1 ± 4.8 (18.3–54.7) |
| Sural sensory† | 41.6 ± 5 (21–56) | 41.6 ± 5 (29.7–58.3) | 41.2 ± 5.2 (23–59) |
| Amplitude (mV) | |||
| Median sensory | 471 | 481 | 475 |
| 22.7 ± 12.4 (3.1–71) | 22.8 ± 11.8 (4.4–78.2) | 22.5 ± 11.5 (2.4–66.1) | |
| Sural sensory | 470 | 481 | 475 |
| 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 motor | 470 | 481 | 473 |
| 29.1 ± 2.5 (22.9–36.5) | 29.1 ± 2.5 (21.6–35.3) | 29 ± 2.5 (21.9–35.4) | |
| Peroneal motor | 402 | 404 | 416 |
| 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”)*‡ | |||
| n | 471 | 481 | 475 |
| Cool thermal | 14.2 ± 4.5 (4.7–25) | 13.9 ± 4.7 (4.7–25) | 14.2 ± 4.3 (5.9–25) |
| Vibratory | 19.3 ± 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) | 454 | 470 | 465 |
| 7.5 ± 4.9 (0–30) | 8.1 ± 5.2 (0–28) | 7.6 ± 5 (0–28) | |
| Monofilament examination 10 g (0–4 points) | 453 | 469 | 464 |
| 1.1 ± 1.3 (0–4) | 1.1 ± 1.4 (0–4) | 1.1 ± 1.3 (0–4) | |
| MNSI (part B) (0–6 points) | 469 | 479 | 472 |
| 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) | 441 | 448 | 442 |
| 3 ± 2.2 (0–14) | 3.4 ± 2.1 (0–10) | 3.1 ± 2.1 (0–12) |