Table 8 Evaluation of Pharmacodynamic Parameters
Parameter | Placebo + Metformin (N = 17) | RE 500 mg + Metformin b | RE 750 mg + Metformin (N = 17) |
|---|---|---|---|
Change from Baseline Weighted Mean Plasma Glucose and Insulin | |||
Glucose (mmol/L), Day 1 | |||
Mean (SD) | 12.65 (3.306) | 13.03 (1.929) | 11.49 (3.536) |
Glucose (mmol/L), Day 13 | |||
Mean (SD) | 11.49 (3.536) | 9.45 (1.502) | 8.84 (1.656) |
Glucose, Change from Baseline | |||
Mean (SD) | −0.10 (1.572) | −3.50 (2.012) | −2.77 (2.262) |
Insulin (pmol/L), Day −1 | |||
Mean (SD) | 176.85(104.735) | 190.96 (100.420) | 191.52 (83.045) |
Insulin (pmol/L), Day 13 | |||
Mean (SD) | 162.97(97.374) | 142.15 (67.626) | 171.57 (74.178) |
Insulin, Change from Baseline | |||
Mean (SD) | −13.88(42.349) | −44.80 (52.746) | −18.95 (47.360) |
Change from Baseline in Body Weight (kg) | |||
Day 2, Mean (SD) | −0.70 (0.679) | −1.03 (0.994) | −1.04 (1.210) |
Day14, Mean (SD) | −1.02 (0.845) | −2.03 (1.235) | −1.84 (1.398) |
Change in Fluid Balance (ml) | |||
Day 2, Mean (SD) | 203.5 (999.83) | − 335.3 (678.37) | − 110.2 (1064.69) |
Day13, Mean (SD)a | −42.0 (1262.56) | − 610.1 (1631.47) | − 416.9 (493.86) |