Table 2.
Efficacy end points
| Between-group difference (95% CI) | |||||
|---|---|---|---|---|---|
| Exenatide QW plus dapagliflozin (n = 228) | Exenatide QW plus placebo (n = 227) | Dapagliflozin plus placebo (n = 230) | Exenatide QW plus dapagliflozin vs. exenatide QW plus placebo | Exenatide QW plus dapagliflozin vs. dapagliflozin plus placebo | |
| Glycemic outcomes | |||||
| HbA1c, % | |||||
| Baseline | 8.92 (0.98) | 8.97 (1.04) | 8.76 (0.91) | ||
| Week 104 | 6.55 (0.52) | 6.68 (0.65) | 7.07 (1.04) | ||
| Change at week 104 | −1.70 (0.11) | −1.29 (0.12) | −1.06 (0.12) | −0.42 (−0.72 to −0.12); P = 0.007 | −0.64 (−0.94 to −0.34); P < 0.001 |
| FPG, mmol/L | |||||
| Baseline | 9.95 (2.20) | 9.47 (2.20) | 9.65 (2.30) | ||
| Week 104 | 6.61 (1.43) | 7.01 (1.58) | 7.75 (1.79) | ||
| Change at week 104 | −2.72 (0.23) | −1.66 (0.25) | −1.22 (0.26) | −1.07 (−1.71 to −0.42); P = 0.001 | −1.50 (−2.16 to −0.85); P < 0.001 |
| 2-h PPG, mmol/L | |||||
| Baseline | 14.45 (3.45) | 13.91 (3.65) | 13.87 (3.50) | ||
| Week 104 | 9.94 (2.59) | 10.46 (3.03) | 11.06 (3.29) | ||
| Change at week 104 | −4.79 (0.33) | −4.39 (0.39) | −3.56 (0.37) | −0.40 (−1.26 to 0.46); P = 0.360 | −1.23 (−2.10 to −0.36); P = 0.006 |
| CV risk factors | |||||
| Body weight, kg | |||||
| Baseline | 94.97 (22.18) | 90.20 (17.77) | 92.09 (14.96) | ||
| Week 104 | 91.15 (20.74) | 88.35 (16.90) | 87.82 (13.15) | ||
| Change at week 104 | −2.48 (0.43) | −0.77 (0.47) | −2.99 (0.49) | −1.71 (−2.95 to −0.47); P = 0.007 | 0.50 (−0.77 to 1.77); P = 0.436 |
| SBP, mmHg | |||||
| Baseline | 131.2 (12.64) | 130.6 (12.04) | 130.3 (12.83) | ||
| Week 104 | 128.5 (12.90) | 131.5 (13.60) | 130.0 (13.37) | ||
| Change at week 104 | −3.1 (1.00) | −0.1 (1.05) | −1.1 (0.98) | −3.0 (−5.7 to −0.2); P = 0.034 | −2.0 (−4.6 to 0.7); P = 0.142 |
Baseline and week 104 data are mean (SD) and reported for patients with observed baseline and week 104 values. Change at week 104 data are adjusted least squares mean (SE), and between-group difference data are least squares mean (95% CI) in the ITT population. Analysis excluded measurements post–rescue therapy and post–premature discontinuation of the study medication, apart from SBP, which included measurements after rescue and excluded measurements post–premature discontinuation of the study medication.