Table 3.
Effects on blood glucose, body weight, and BP in subgroups classified by baseline BP
| Dose | Total | SBP | DBP | |||
|---|---|---|---|---|---|---|
| <130 mmHg | ≥130 mmHg | <80 mmHg | ≥80 mmHg | |||
| 100 mg | HbA1c (%) | |||||
| Number of patients | 584 | 295 | 289 | 334 | 250 | |
| Baseline | 8.05 [0.88] | 8.09 [0.91] | 8.01 [0.85] | 8.09 [0.93] | 8.00 [0.81] | |
| Week 52 | 7.11 [0.76] | 7.13 [0.71] | 7.09 [0.80] | 7.11 [0.72] | 7.12 [0.81] | |
| Change from baseline at week 52 | −0.94 [0.77] | −0.95 [0.75] | −0.92 [0.79] | −0.98 [0.77] | −0.88 [0.77] | |
| Paired t test | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | |
| FPG (mg/dL) | ||||||
| Number of patients | 583 | 295 | 288 | 334 | 249 | |
| Baseline | 158.9 [35.3] | 157.1 [35.3] | 160.8 [35.3] | 157.2 [35.9] | 161.3 [34.5] | |
| Week 52 | 129.3 [27.9] | 127.9 [26.6] | 130.7 [29.2] | 127.4 [26.0] | 131.7 [30.2] | |
| Change from baseline at week 52 | −29.7 [34.2] | −29.3 [36.0] | −30.1 [32.4] | −29.8 [35.5] | −29.6 [32.5] | |
| Paired t test | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | |
| Body weight (kg) | ||||||
| Number of patients | 584 | 295 | 289 | 334 | 250 | |
| Baseline | 70.44 [15.56] | 68.80 [15.51] | 72.12 [15.46] | 66.70 [14.76] | 75.45 [15.22] | |
| Week 52 | 67.76 [15.35] | 66.26 [15.33] | 69.29 [15.24] | 64.09 [14.65] | 72.67 [14.91] | |
| Change from baseline at week 52 | −2.68 [2.51] | −2.54 [2.44] | −2.83 [2.59] | −2.61 [2.31] | −2.78 [2.76] | |
| Paired t test | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | |
| SBP (mmHg) | ||||||
| Number of patients | 584 | 295 | 289 | 334 | 250 | |
| Baseline | 128.87 [13.10] | 118.29 [8.11] | 139.67 [6.94] | 123.00 [12.27] | 136.73 [9.58] | |
| Week 52 | 124.11 [13.01] | 117.51 [11.24] | 130.84 [11.11] | 119.80 [12.38] | 129.86 [11.54] | |
| Change from baseline at week 52 | −4.76 [11.43] | −0.78 [10.25] | −8.83 [11.14] | −3.19 [11.10] | −6.86 [11.53] | |
| Paired t test | <0.001 | 0.192 | <0.001 | <0.001 | <0.001 | |
| DBP (mmHg) | ||||||
| Number of patients | 584 | 295 | 289 | 334 | 250 | |
| Baseline | 77.76 [9.60] | 73.07 [8.41] | 82.54 [8.30] | 71.18 [6.55] | 86.54 [4.79] | |
| Week 52 | 74.89 [9.87] | 72.30 [9.36] | 77.52 [9.69] | 70.22 [8.44] | 81.11 [8.04] | |
| Change from baseline at week 52 | −2.87 [7.49] | −0.77 [7.43] | −5.02 [6.92] | −0.96 [7.06] | −5.43 [7.30] | |
| Paired t test | <0.001 | 0.077 | <0.001 | 0.013 | <0.001 | |
| 200 mg | HbA1c (%) | |||||
| Number of patients | 713 | 377 | 336 | 394 | 319 | |
| Baseline | 8.09 [0.86] | 8.08 [0.87] | 8.10 [0.86] | 8.04 [0.86] | 8.15 [0.87] | |
| Week 52 | 7.04 [0.69] | 7.00 [0.67] | 7.09 [0.72] | 7.01 [0.67] | 7.08 [0.72] | |
| Change from baseline at week 52 | −1.05 [0.76] | −1.08 [0.72] | −1.01 [0.80] | −1.03 [0.75] | −1.07 [0.78] | |
| Paired t test | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | |
| FPG (mg/dL) | ||||||
| Number of patients | 711 | 376 | 335 | 393 | 318 | |
| Baseline | 158.9 [34.4] | 161.1 [35.9] | 156.5 [32.6] | 157.2 [34.9] | 161.0 [33.8] | |
| Week 52 | 124.9 [22.6] | 123.8 [21.5] | 126.2 [23.7] | 122.5 [20.5] | 128.0 [24.6] | |
| Change from baseline at week 52 | −34.0 [30.7] | −37.3 [29.9] | −30.3 [31.3] | −34.8 [29.8] | −33.0 [31.8] | |
| Paired t test | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | |
| Body weight (kg) | ||||||
| Number of patients | 713 | 377 | 336 | 394 | 319 | |
| Baseline | 69.73 [14.66] | 69.02 [15.02] | 70.53 [14.22] | 66.30 [13.65] | 73.97 [14.77] | |
| Week 52 | 66.66 [14.34] | 65.87 [14.49] | 67.56 [14.13] | 63.20 [13.13] | 70.94 [14.63] | |
| Change from baseline at week 52 | −3.07 [2.79] | −3.16 [2.66] | −2.97 [2.92] | −3.10 [2.68] | −3.03 [2.92] | |
| Paired t test | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | |
| SBP (mmHg) | ||||||
| Number of patients | 713 | 377 | 336 | 394 | 319 | |
| Baseline | 128.48 [13.00] | 118.59 [8.44] | 139.58 [6.76] | 122.43 [12.14] | 135.95 [9.76] | |
| Week 52 | 122.00 [13.37] | 116.51 [11.94] | 128.17 [12.15] | 117.91 [13.04] | 127.05 [11.98] | |
| Change from baseline at week 52 | −6.48 [12.56] | −2.09 [10.83] | −11.41 [12.55] | −4.52 [11.95] | −8.91 [12.89] | |
| Paired t test | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | |
| DBP (mmHg) | ||||||
| Number of patients | 713 | 377 | 336 | 394 | 319 | |
| Baseline | 77.97 [9.92] | 73.59 [8.83] | 82.88 [8.70] | 70.82 [6.65] | 86.79 [4.90] | |
| Week 52 | 74.05 [9.76] | 71.68 [9.22] | 76.72 [9.68] | 69.24 [8.15] | 80.01 [8.18] | |
| Change from baseline at week 52 | −3.91 [8.11] | −1.91 [7.26] | −6.16 [8.42] | −1.58 [7.26] | −6.79 [8.19] | |
| Paired t test | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | |
Missing data at week 52 were imputed using last observation carried forward method. Data are shown as mean [standard deviation]
DBP diastolic blood pressure, FPG fasting plasma glucose, HbA1c hemoglobin A1c, SBP systolic blood pressure