Table 5.

Changes in clinical/laboratory variables after single (Day 1) and multiple (Day 7) doses of luseogliflozin compared with placebo

	Placebo (N = 8)	Luseogliflozin
		0.5 mg (N = 7)	1 mg (N = 8)	2.5 mg (N = 8)	5 mg (N = 8)
Urinary uric acid (g/day)
Baseline	0.75 ± 0.12	0.65 ± 0.08	0.64 ± 0.11	0.78 ± 0.09	0.70 ± 0.13
Change from baseline to Day 1	−0.04 ± 0.05	0.04 ± 0.05	0.08 ± 0.07	−0.01 ± 0.04	0.08 ± 0.12
Change from baseline to Day 7	−0.03 ± 0.07	−0.01 ± 0.07	−0.03 ± 0.20	−0.06 ± 0.07	0.01 ± 0.10
Cystatin C (mg/L)
Baseline	0.804 ± 0.111	0.944 ± 0.174	0.906 ± 0.109	0.880 ± 0.138	0.925 ± 0.139
Change from baseline to Day 1	−0.035 ± 0.042	−0.040 ± 0.018	0.005 ± 0.077	0.016 ± 0.060	0.028 ± 0.042
Change from baseline to Day 7	−0.060 ± 0.050	−0.067 ± 0.029	−0.061 ± 0.043	−0.064 ± 0.054	−0.027 ± 0.065
Urinary NAG (U/L)
Baseline	2.80 ± 1.27	2.19 ± 1.05	2.38 ± 1.88	2.58 ± 1.99	2.70 ± 1.78
Change from baseline to Day 1	0.43 ± 0.68	−0.31 ± 0.67	−0.33 ± 0.99	−0.68 ± 1.33	−0.81 ± 1.01
Change from baseline to Day 7	0.26 ± 0.81	−0.06 ± 0.80	0.73 ± 0.80	−0.08 ± 1.26	−0.11 ± 1.18
Urinary β2-microglobulin (μg/L)
Baseline	65.5 ± 32.2	76.0 ± 117.3	44.3 ± 38.6	77.3 ± 45.2	30.5 ± 15.4
Change from baseline to Day 1	11.9 ± 25.7	−12.4 ± 25.2	−8.5 ± 31.3	−11.0 ± 44.9	−1.3 ± 13.5
Change from baseline to Day 7	4.1 ± 36.6	−7.4 ± 27.1	17.3 ± 54.9	5.5 ± 44.0	1.4 ± 20.3
Serum calcium (mg/dL)
Baseline	9.16 ± 0.30	9.45 ± 0.37	9.09 ± 0.35	9.19 ± 0.34	9.29 ± 0.16
Change from baseline to Day 1	−0.19 ± 0.27	−0.19 ± 0.12	−0.19 ± 0.16	−0.15 ± 0.23	−0.10 ± 0.20
Change from baseline to Day 7	−0.15 ± 0.33	−0.24 ± 0.05	−0.41 ± 0.14	−0.40 ± 0.27	−0.16 ± 0.45
Urinary calcium (g/day)
Baseline	0.13 ± 0.05	0.10 ± 0.05	0.13 ± 0.05	0.11 ± 0.08	0.13 ± 0.05
Change from baseline to Day 1	0.01 ± 0.04	0.01 ± 0.04	0.00 ± 0.00	−0.01 ± 0.04	−0.01 ± 0.04
Change from baseline to Day 7	0.03 ± 0.07	0.01 ± 0.04	0.00 ± 0.00	0.00 ± 0.05	−0.03 ± 0.05
Serum phosphorus (mg/dL)
Baseline	3.16 ± 0.38	3.38 ± 0.44	3.06 ± 0.32	3.13 ± 0.24	3.59 ± 0.36
Change from baseline to Day 1	0.00 ± 0.05	0.30 ± 0.40	0.57 ± 0.32	0.68 ± 0.23	1.08 ± 0.37
Change from baseline to Day 7	0.11 ± 0.15	0.16 ± 0.40	0.20 ± 0.21	0.38 ± 0.29	0.42 ± 0.39
Urinary phosphorus (g/day)
Baseline	0.78 ± 0.13	0.78 ± 0.20	0.69 ± 0.16	0.81 ± 0.11	0.78 ± 0.18
Change from baseline to Day 1	−0.08 ± 0.07	−0.13 ± 0.10	−0.13 ± 0.10	−0.24 ± 0.07	−0.24 ± 0.11
Change from baseline to Day 7	−0.05 ± 0.13	−0.04 ± 0.13	0.00 ± 0.13	−0.03 ± 0.17	−0.01 ± 0.14
Urinary type IV collagen (μg/g creatinine)
Baseline	3.74 ± 1.46	3.39 ± 2.95	3.31 ± 1.55	4.03 ± 1.95	3.18 ± 0.95
Change from baseline to Day 1	0.36 ± 0.53	−0.40 ± 1.08	−0.44 ± 0.61	−0.05 ± 1.13	0.11 ± 0.97
Change from baseline to Day 7	−0.26 ± 0.99	−0.21 ± 1.25	0.66 ± 1.22	0.21 ± 1.85	0.31 ± 1.26
Hematocrit (%)
Baseline	40.26 ± 3.10	42.11 ± 3.99	42.60 ± 3.63	41.15 ± 3.32	41.95 ± 3.93
Change from baseline to Day 1	−1.57 ± 1.19	−1.14 ± 0.73	−1.26 ± 0.86	−0.58 ± 1.48	−0.54 ± 0.85
Change from baseline to Day 7	−3.06 ± 0.44	−2.20 ± 0.95	−2.68 ± 0.89	−2.89 ± 1.81	−1.66 ± 1.99
SBP (mmHg)
Baseline	133.8 ± 20.9	124.3 ± 12.4	123.3 ± 15.9	123.0 ± 17.4	120.0 ± 18.6
Change from baseline to Day 1	4.5 ± 5.1	−1.7 ± 6.0	3.5 ± 9.6	−5.6 ± 9.5	−1.3 ± 12.5
Change from baseline to Day 7	−1.4 ± 7.2	−5.9 ± 3.8	−2.4 ± 12.8	−8.8 ± 10.9	−11.3 ± 11.8
DBP (mmHg)
Baseline	84.6 ± 11.4	76.6 ± 8.7	80.1 ± 8.7	82.0 ± 11.3	79.6 ± 9.0
Change from baseline to Day 1	3.1 ± 6.1	3.0 ± 5.2	0.4 ± 4.9	−4.3 ± 5.6	0.6 ± 6.0
Change from baseline to Day 7	0.4 ± 3.9	3.1 ± 3.8	−0.8 ± 6.6	−6.1 ± 5.6	−3.1 ± 6.0

Values are presented as the mean ± standard deviation

NAG N-acetyl-β-(d)-glucosaminidase, SBP systolic blood pressure, DBP diastolic blood pressure