Table 3. Efficacy at 24 weeks.
| Insulin (n = 15) | Insulin + tofogliflozin (n = 19) | Glargine + tofogliflozin (n = 19) | |
|---|---|---|---|
| HbA1c, % | |||
| Baseline (SD) | 8.1 (0.3) | 9.0 (1.2) | 8.8 (0.9) |
| Adjusted mean change from baseline (95% CI; P-value) | -0.3 (-0.60 to 0.02; 0.062) | -1.0 (-1.49 to -0.59; 0.0001) | -0.8 (-1.28 to -0.22; 0.008) |
| Fasting plasma glucose, mg/dL | |||
| Baseline (SD) | 165.0 (16.6) | 185.5 (24.6) | 171.9 (24.1) |
| Adjusted mean change from baseline (95% CI; P-value) | -10.9 (-20.9 to -0.87; 0.0359) | -61.3 (-81.86 to -39.76; < 0.0001) | -33.1 (-46.41 to -19.73; 0.0001) |
| Total weight, kg | |||
| Baseline (SD) | 69.8 (15.6) | 83.6 (20.5) | 79.2 (22.1) |
| Adjusted mean change from baseline (95% CI; P-value) | 0.6 (-0.28 to 1.39; 0.1772) | -2.9 (-4.46 to -1.27; 0.0014) | -3.4 (-4.87 to -1.91; 0.0002) |
| Mean daily insulin dose, U | |||
| Baseline (SD) | 35.9 (16.0) | 42.2 (23.1) | 39.9 (12.1) |
| Adjusted mean change from baseline (95% CI; P-value) | 5.1 (3.10 to 7.02; < 0.0001) | -2.6 (-5.57 to 0.45; 0.091) | -12.7 (-15.2 to -10.2; < 0.0001) |
| Systolic blood pressure, mm Hg | |||
| Baseline (SD) | 126.4 (9.5) | 127.5 (13.7) | 130.5 (5.9) |
| Adjusted mean change from baseline (95% CI; P-value) | 1.1 (-5.83 to 7.97; 0.7341) | -4.2 (-10.66 to 2.33; 0.1937) | -7.8 (-15.27 to -0.26; 0.0435) |
| Diastolic blood pressure, mm Hg | |||
| Baseline (SD) | 74.3 (12.9) | 76.4 (13.3) | 74.6 (10.3) |
| Adjusted mean change from baseline (95% CI; P-value) | 0.5 (-5.60 to 6.67; 0.8548) | -5.6 (-13.71 to 2.49; 0.1623) | -3.3 (-8.68 to 2.06; 0.2083) |
| HDL cholesterol, mg/dL | |||
| Baseline (SD) | 54.5 (12.5) | 54.0 (12.5) | 54.5 (10.1) |
| Adjusted mean change from baseline (95% CI; P-value) | 2.3 (-4.15 to 8.93; 0.4429) | 1.8 (-1.01 to 4.68; 0.1925) | -1.57 (3.61 to 0.46; 0.1191) |
| Triglycerides, mg/dL | |||
| Baseline (SD) | 147.8 (72.2) | 166.6 (114.4) | 152.9 (55.8) |
| Adjusted mean change from baseline (95% CI; P-value) | -0.85 (-22.40 to 20.71; 0.9333) | -13.1 (-59.31 to 33.09; 0.5572) | -25.6 (-44.39 to -6.89; 0.0112) |
| LDL cholesterol, mg/dL | |||
| Baseline (SD) | 102.2 (19.2) | 103.2 (17.3) | 108.6 (24.2) |
| Adjusted mean change from baseline (95% CI; P-value) | 2.0 (-5.00 to 9.00; 0.5455) | 2.2 (-4.28 to 8.73; 0.4807) | 2.2 (-4.28 to 8.72; 0.4807) |
| Total cholesterol, mg/dL | |||
| Baseline (SD) | 102.2 (19.2) | 103.2 (17.3) | 108.6 (24.2) |
| Adjusted mean change from baseline (95% CI; P-value) | 2.0 (-5.00 to 9.00; 0.5455) | 2.2 (-4.28 to 8.73; 0.4807) | 2.2 (-4.28 to 8.72; 0.4807) |
| eGFR, mL/min/1.73 m2 | |||
| Baseline (SD) | 85.3 (23.1) | 89.4 (34.6) | 91.7 (29.3) |
| Adjusted mean change from baseline (95% CI; P-value) | -10.9 (-20.73 to -1.00; 0.0332) | -8.8 (-14.28 to -3.28; 0.0037) | -3.2 (-11.56 to 5.14; 0.4282) |
n: number of patients in the full analysis set. BMI: body mass index; OAD: oral antidiabetic drug; SD: standard deviation; SBP: systolic blood pressure; DBP: diastolic blood pressure.