Skip to main content

Table 8 Evaluation of Pharmacodynamic Parameters

From: Assessment of safety and tolerability of remogliflozin etabonate (GSK189075) when administered with total daily dose of 2000 mg of metformin

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)
  1. RE Remogliflozin Etabonate, SD Standard deviation
  2. aAnalyzed subjects on Day 13 for RE 500 mg + Metformin group were 15, bAnalyzed subjects on day 13 for RE 750 mg + Metformin group were 16