Table 3 Changes in primary and secondary endpoints from baseline to week 24 and proportion of patients with target HbA 1c levels at week 24 (FAS)
Variable | Placebo | Tofogliflozin | ||
|---|---|---|---|---|
10 mg | 20 mg | 40 mg | ||
HbA1c (%) | ||||
N | 56 | 57 | 58 | 58 |
LS mean (95% CI) | −0.028 (−0.192 to 0.137) | −0.797 (−0.960 to −0.634)††† | −1.017 (−1.178 to −0.856)††† | −0.870 (−1.031 to −0.709)††† |
Placebo-adjusted difference | — | −0.769 | −0.990 | −0.842 |
Fasting blood glucose (mg/dL) | ||||
N | 56 | 57 | 58 | 58 |
LS mean (95% CI) | −8.561 (−13.247 to −3.875) | −31.868 (−36.514 to −27.222)††† | −35.899 (−40.504 to −31.294)††† | −32.327 (−36.933 to −27.722)††† |
Placebo-adjusted difference | — | −23.307 | −27.338 | −23.766 |
Body weight (kg) | ||||
N | 56 | 57 | 58 | 58 |
LS mean (95% CI) | −0.356 (−0.836 to 0.123) | −2.230 (−2.704 to −1.756)††† | −2.851 (−3.320 to −2.382)††† | −2.971 (−3.440 to −2.502)††† |
Placebo-adjusted difference | — | −1.87 | −2.50 | −2.61 |
Glycoalbumin (%) | ||||
N | 53 | 55 | 58 | 58 |
Mean (SD) | 0.19 (2.07) | −3.09 (2.19)***††† | −3.52 (2.84)***††† | −3.01 (2.33)***††† |
2-h PPG (mg/dL) | ||||
N | 48 | 53 | 56 | 53 |
Mean (SD) | −3.33 (47.6) | −63.5 (49.0)***††† | −71.0 (63.7)***††† | −60.2 (47.2)***††† |
Fasting insulin (μU/mL) | ||||
N | 48 | 52 | 56 | 57 |
Mean (SD) | −0.44 (4.59) | −1.36 (2.95)** | −2.12 (5.81)** | −2.01 (2.80)***† |
2-h postprandial insulin (μU/mL) | ||||
N | 45 | 50 | 56 | 54 |
Mean (SD) | −0.26 (8.81) | −4.14 (10.59)** | −7.25 (13.74)***†† | −5.58 (7.73)***†† |
HOMA-β | ||||
N | 48 | 52 | 56 | 57 |
Mean (SD) | −0.26 (15.62) | 5.15 (13.48)** | 3.97 (26.70) | 2.67 (12.90) |
HOMA − IR | ||||
N | 48 | 52 | 56 | 57 |
Mean (SD) | −0.296 (2.212) | −1.136 (1.532)***† | −1.469 (2.407)***† | −1.345 (1.601)*** †† |
Matsuda Index | ||||
N | 40 | 45 | 50 | 49 |
Mean (SD) | 0.434 (2.764) | 2.137 (2.447)***†† | 2.233 (2.339)***†† | 2.351 (1.954)***††† |
Serum lipids | ||||
Total cholesterol (mg/dL) | ||||
N | 53 | 55 | 58 | 58 |
Mean (SD) | −6.8 (26.6) | −2.5 (20.6) | −3.1 (28.4) | 1.1 (23.8) |
LDL-cholesterol (mg/dL) | ||||
N | 53 | 55 | 58 | 58 |
Mean (SD) | −4.3 (21.6) | −2.7 (19.8) | −2.2 (24.0) | 4.5 (21.9)† |
HDL-cholesterol (mg/dL) | ||||
N | 53 | 55 | 58 | 58 |
Mean (SD) | −0.2 (7.3) | 3.3 (7.5)**† | 3.9 (11.0)**† | 4.5 (8.6)***†† |
Triglycerides (mg/dL) | ||||
N | 53 | 55 | 58 | 58 |
Mean (SD) | −21.5 (206.2) | −20.7 (119.1) | −23.9 (83.8)* | −44.5 (95.1)*** |
Adiponectin (μg/mL) | ||||
N | 53 | 55 | 58 | 58 |
Mean (SD) | −0.17 (0.99) | 0.71 (1.11)***††† | 0.96 (1.61)***††† | 0.45 (2.73) |
Systolic blood pressure (mmHg) | ||||
N | 56 | 57 | 58 | 58 |
Mean (SD) | −3.2 (13.1) | −6.8 (13.1)*** | −7.6 (11.4)*** | −9.4 (11.1)***†† |
Diastolic blood pressure (mmHg) | ||||
N | 56 | 57 | 58 | 58 |
Mean (SD) | −1.4 (9.8) | −5.6 (9.8)***† | −4.1 (8.4)*** | −4.1 (8.3)*** |
Waist circumference (cm) | ||||
N | 53 | 55 | 58 | 58 |
Mean (SD) | 0.02 (3.95) | −2.42 (3.37)***††† | −2.47 (2.99)***††† | −2.27 (3.22)***†† |