Table 1.
Demographic, laboratory, and efficacy parameters in the ITT population at baseline
| Actovegin | Placebo | |
|---|---|---|
| n | 281 | 286 |
| Age (years) | 55.7 ± 6.4 | 55.6 ± 6.3 |
| Sex (% male) | 31 | 27 |
| Race (Caucasian/Mongolian) (%) | 95/5 | 93/7 |
| BMI (kg/m2) | 30.6 ± 5.5 | 30.7 ± 4.8 |
| Systolic blood pressure (mmHg) | 134.6 ± 12.5 | 135.2 ± 12.7 |
| Diastolic blood pressure (mmHg) | 81.1 ± 7.3 | 81.6 ± 7.4 |
| Heart rate (bpm) | 74.1 ± 6.4 | 74.8 ± 6.0 |
| Smoker (%) | 10 | 15 |
| Alcohol drinker (%) | 58 | 53 |
| Insulin treatment (%) | 41 | 41 |
| Duration of diabetes (years) | 8.4 ± 6.4 | 7.9 ± 6.7 |
| Duration of neuropathy (years) | 2.9 ± 3.0 | 2.5 ± 2.8 |
| Retinopathy (%) | 26 | 19 |
| Nephropathy (%) | 5 | 4 |
| Cardiac disorders (%) | 41 | 33 |
| Peripheral artery disease (%) | 11 | 10 |
| Hypertension (%) | 79 | 81 |
| A1C (%) | 7.9 ± 1.5 | 7.7 ± 1.5 |
| Fasting blood glucose (mmol/l) | 8.4 ± 2.2 | 8.3 ± 2.3 |
| TSS | 8.3 ± 1.7 | 8.4 ± 1.6 |
| VPT (volts) | 19.7 ± 6.3 | 20.0 ± 5.8 |
| NIS-LL | 8.4 ± 6.5 | 8.8 ± 7.3 |
| SF-36, physical health | 39.8 ± 7.7 | 39.9 ± 7.5 |
| SF-36, mental health | 39.8 ± 11.9 | 39.9 ± 10.3 |
Data are means ± SD, unless otherwise indicated.