Table 1.
Demographics and biochemical characteristics of patients of the PKPD database and the simulation database.
| PKPD database | Simulation database | ||||||
|---|---|---|---|---|---|---|---|
| Phase II studies | Phase III studies Glicazide MR vs. glicazide | Phase III studies Glicazide MR vs. glicazide | |||||
| Dose ranging | Dose increase | Study A | Study B | Study A | Total on PKPD database | Study A | |
| Number of patients | 176 | 50 | 242 | 166 | 634 | 232 | |
| Age (years) | 61 ± 10 | 60 ± 8 | 61 ± 10 | 61 ± 10 | 61 ± 10 | 62 ± 10 | |
| Weight (kg) | 77 ± 11 | 85 ± 9 | 79 ± 12 | 81 ± 14 | 80 ± 12 | 79 ± 12 | |
| BMI (kg/m2) | 28 ± 3 | 28 ± 2 | 28 ± 4 | 28 ± 4 | 28 ± 3 | 29 ± 3 | |
| Creatinine clearance(ml min−1) | 92 ± 25 | 122 ± 27 | 102 ± 28 | 103 ± 33 | 102 ± 30 | 101 ± 29 | |
| Gender | |||||||
| Male | 94 | 35 | 134 | 102 | 365 | 132 | |
| Female | 82 | 15 | 108 | 64 | 269 | 100 | |
| Race | |||||||
| Caucasian | 176 | 473 | 240 | 147 | 610 | 230 | |
| Others | 0 | 3 | 3 | 19 | 24 | 2 | |
| HbA1c (%) | 8.1 ± 1.8 | 7.6 ± 1.0 | 8.1 ± 1.0 | 8.2 ± 1.0 | 8.1 ± 1.3 | 8.3 ± 1.0 | |
| FPG (mmol l−1) | 11.4 ± 2.5 | 11.8 ± 2.4 | 10.6 ± 2.1 | 10.8 ± 2.1 | 11.0 ± 2.3 | 10.8 ± 2.0 | |
| Diabetes duration (years) | 6.9 ± 6.6 | 8.6 ± 9.0 | 6.3 ± 5.6 | 5.2 ± 5.0 | 6.3 ± 6.2 | 6.8 ± 5.9 | |
| Previous treatment | |||||||
| Diet alone | 30 | 1 | 56 | 38 | 125 | 51 | |
| 1 OHA class | 122 | 38 | 152 | 108 | 420 | 158 | |
| 2 OHA classes | 24 | 11 | 34 | 20 | 89 | 23 | |
OHA, oral hypoglycaemic agent; BMI, body mass index; FPG, fasting plasma glucose.