Table 1.
Baseline characteristics of the study participants (ITT population)
| Baseline characteristic | Placebo (n = 51) | FREMS (n = 50) |
|---|---|---|
| Sex, % women | 39 (25.8, 53.9) | 28 (16.2, 42.3) |
| Age, years | 61.3 ± 8.3 | 59.0 ± 10.6 |
| Diabetes, No. (%) | ||
| Type 1 | 9 (17.6) | 10 (20) |
| Type 2 | 42 (82.4) | 40 (80) |
| Duration of diabetes, years | 12 (8, 25) | 13 (10, 18) |
| BMI, kg/m2 | 28.5 ± 4.8 | 28.8 ± 4.8 |
| HbA1c a | ||
| % | 7.6 ± 1.2 | 7.9 ± 1.2 |
| mmol/mol | 59.8 ± 13.0 | 63.1 ± 13.4 |
| Diabetes treatment, % | ||
| Lifestyle modification | 18 (8.4, 30.9) | 14 (5.8, 26.7) |
| Oral agents | 29 (17.5, 43.8) | 44 (30.0, 58.7) |
| Oral agents and insulin | 18 (8.4, 30.9) | 8 (2.2, 19.2) |
| Insulin | 35 (22.4, 50.0) | 34 (21.2, 48.8) |
| Serum creatinine, μmol/l | 83.1 ± 18.5 | 85.7 ± 24.7 |
| MDNS | 13.7 ± 5.0 | 11.6 ± 4.6 |
| Night-time pain, VAS score | 45.2 ± 29.6 | 41.3 ± 29.7 |
| Daytime pain, VAS score | 40.9 ± 24.0 | 31.6 ± 26.3 |
| Vibration perception threshold, μm | 22.4 ± 23.1 | 24.2 ± 26.5 |
| Warm sensation threshold, °C | 38.0 ± 9.3 | 38.5 ± 9.2 |
| Cold sensation threshold, °C | 26.5 ± 7.6 | 26.0 ± 7.7 |
| NCV, m/s | ||
| Sural nerve | 42.2 ± 6.3 | 42.0 ± 4.3 |
| Tibial nerve | 42.3 ± 4.6 | 40.1 ± 6.8 |
| Deep peroneal nerve | 43.8 ± 4.8 | 41.5 ± 5.0 |
| Amplitude | ||
| Sural nerve, μV | 4.98 ± 3.29 | 4.82 ± 3.91 |
| Tibial nerve, mV | 10.47 ± 5.82 | 8.59 ± 5.87 |
| Deep peroneal nerve, mV | 5.43 ± 3.28 | 4.80 ± 3.37 |
Continuous variables are presented as mean ± SD and categorical variables as percentage (95% CI)
aThe normal range for HbA1c is 3.5–6.0% (15–42 mmol/mol).