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)***†† |
*P < 0.05, **P < 0.01, and ***P < 0.001 vs. baseline.
†P < 0.05, ††P < 0.01, and †††P < 0.001 vs. placebo.
Abbreviations: LS mean least squares mean, 95% CI 95% confidence interval, NGSP National Glycohemoglobin Standardization Program, HOMA-β Homeostatic model assessment of β cell function, HOMA-IR Homeostatic model assessment of insulin resistance, 2-h PPG 2-hour postprandial glucose.