TABLE 1.
Estimated metformin steady-state pharmacokinetic parameters for pregnant women with GDM and nonpregnant women with T2DM separated by dose
Results are reported as means ± S.D. Mann-Whitney test was used to compare PK parameters for pregnant and nonpregnant women receiving either 500- or 1000-mg doses. P < 0.05 was considered significant.
| 500 mg Pregnant (n = 39) | 500 mg Nonpregnant (n = 9) | P Value | 1000 mg Pregnant (n = 15) | 1000 mg Nonpregnant (n = 14) | P Value | |
|---|---|---|---|---|---|---|
| Metformin | ||||||
| F | 0.64 ± 0.2 | 0.49 ± 0.08 | <0.01 | 0.53 ± 0.11 | 0.37 ± 0.14 | <0.01 |
| Half-life (h) | 4.2 ± 1.1 | 4.0 ± 0.8 | 0.4 | 4.3 ± 0.7 | 3.7 ± 0.6 | 0.2 |
| Tmax (h) | 2.6 ± 1.3 | 2.1 ± 0.5 | <0.01 | 2.4 ± 1.1 | 2.2 ± 1.3 | 0.7 |
| VB/F (l) | 368 ± 133 | 276 ± 52 | <0.05 | 450 ± 136 | 486 ± 207 | 0.6 |
| VB/F (l/kg) | 4.00 ± 1.68 | 3.19 ± 1.10 | 0.08 | 4.99 ± 1.64 | 5.00 ± 2.07 | 0.9 |
| VB (l) | 242 ± 138 | 134 ± 23 | <0.001 | 234 ± 66 | 163 ± 48 | <0.005 |
| VB (l/kg) | 2.6 ± 1.6 | 1.5 ± 0.3 | <0.005 | 2.6 ± 0.9 | 1.7 ± 0.6 | <0.005 |
| CL/F (ml/min) | 1085 ± 328 | 854 ± 230 | <0.05 | 1405 ± 384 | 1678 ± 574 | 0.4 |
| CL/F (ml/min per kilogram) | 11.7 ± 3.8 | 9.5 ± 2.4 | 0.05 | 15.6 ± 4.5 | 17.5 ± 6.5 | 0.3 |
| CL (ml/min) | 731 ± 339 | 444 ± 121 | <0.01 | 758 ± 179 | 572 ± 153 | <0.05 |
| CL (ml/min per kilogram) | 7.9 ± 3.9 | 4.9 ± 1.3 | <0.01 | 8.5 ± 2.5 | 6.1 ± 2.4 | <0.05 |
| Percent of dose recovered in the urine unchanged (%) | 64 ± 20 | 49 ± 8 | <0.01 | 53 ± 11 | 37 ± 14 | <0.01 |
| CLR (ml/min) | 731 ± 339 | 444 ± 121 | <0.01 | 758 ± 179 | 572 ± 153 | <0.05 |
| CLR (ml/min per kilogram) | 7.9 ± 3.9 | 4.9 ± 1.3 | <0.01 | 8.5 ± 2.5 | 6.1 ± 2.4 | <0.05 |
| CrCL (ml/min) | 233 ± 68 | 148 ± 41 | <0.001 | 233 ± 46 | 166 ± 25 | <0.001 |
| CLsec (ml/min) | 497 ± 312 | 296 ± 97 | 0.06 | 530 ± 168 | 406 ± 143 | 0.1 |
| CLsec (ml/min per kilogram) | 5.4 ± 3.6 | 3.3 ± 1.1 | <0.05 | 5.9 ± 2.3 | 4.3 ± 2.0 | 0.2 |