Table 1.
Primary and secondary efficacy end points at weeks 28 and 52 in the intention-to-treat patient population
| | Exenatide QW + dapagliflozin (n = 228) | Exenatide QW + placebo (n = 227) | Dapagliflozin + placebo (n = 230) | Between-group difference (95% CI) | |
|---|---|---|---|---|---|
| Exenatide QW + dapagliflozin vs. exenatide QW + placebo | Exenatide QW + dapagliflozin vs. dapagliflozin + placebo | ||||
| HbA1c, % | |||||
| Baseline | 9.34 (1.07) | 9.30 (1.06) | 9.30 (1.03) | ||
| Week 28 | 7.24 (1.28) | 7.58 (1.30) | 7.74 (1.13) | ||
| Change at week 28 | −1.98 (0.09) | −1.60 (0.10) | −1.39 (0.09) | −0.38 (−0.63 to −0.13); P = 0.003 | −0.59 (−0.84 to −0.34); P < 0.001 |
| Week 52 | 6.87 (0.78) | 7.21 (1.04) | 7.36 (0.86) | ||
| Change at week 52 | −1.75 (0.10) | −1.38 (0.10) | −1.23 (0.10) | −0.37 (−0.64 to −0.11); P = 0.006 | −0.52 (−0.79 to −0.26); P < 0.001 |
| HbA1c, mmol/mol | |||||
| Baseline | 79 (11.7) | 78 (11.6) | 78 (11.3) | ||
| Week 28 | 56 (14.0) | 59 (14.2) | 61 (12.4) | ||
| Change at week 28 | −21.6 (1.0) | −17.5 (1.1) | −15.2 (1.0) | −4.2 (−6.9 to −1.4); P = 0.003 | −6.4 (−9.2 to −3.7); P < 0.001 |
| Week 52 | 52 (8.5) | 55 (11.4) | 57 (9.4) | ||
| Change at week 52 | −19.1 (1.1) | −15.1 (1.1) | −13.4 (1.1) | −4.0 (−7.0 to −1.2); P = 0.006 | −5.7 (−8.6 to −2.8); P < 0.001 |
| HbA1c <7.0%* | |||||
| Week 28 | 108 (47.4; 40.9–53.9) | 70 (30.8; 24.8–36.8) | 46 (20.0; 14.8–25.2) | 16.5; P < 0.001 | 27.4; P < 0.001 |
| Week 52 | 86 (37.7; 31.4–44.0) | 68 (30.0; 24.0–35.9) | 38 (16.5; 11.7–21.3) | 7.8; P = 0.079 | 21.2; P < 0.001 |
| HbA1c ≤6.5%† | |||||
| Week 28 | 72 (31.6; 25.6–37.6) | 48 (21.1; 15.8–26.5) | 25 (10.9; 6.9–14.9) | 10.4; P = 0.011 | 20.7; P < 0.001 |
| Week 52 | 60 (26.3; 20.6–32.0) | 39 (17.2; 12.3–22.1) | 20 (8.7; 5.1–12.3) | 9.1; P = 0.018 | 17.6; P < 0.001 |
| FPG, mmol/L | |||||
| Baseline | 11.01 (3.01) | 10.66 (2.80) | 10.58 (2.63) | ||
| Week 28 | 7.17 (1.90) | 8.21 (2.75) | 7.89 (1.93) | ||
| Change at week 28 | −3.66 (0.16) | −2.54 (0.17) | −2.73 (0.16) | −1.12 (−1.55 to −0.68); P < 0.001 | −0.92 (−1.36 to −0.49); P < 0.001 |
| Week 52 | 6.66 (1.55) | 7.48 (1.93) | 7.78 (1.92) | ||
| Change at week 52 | −3.50 (0.16) | −2.52 (0.17) | −2.21 (0.17) | −0.98 (−1.42 to −0.54); P < 0.001 | −1.29 (−1.73 to −0.85); P < 0.001 |
| 2-h PPG, mmol/L | |||||
| Baseline | 15.04 (3.69) | 14.96 (3.70) | 14.58 (3.38) | ||
| Week 28 | 9.84 (2.65) | 11.38 (3.38) | 11.23 (3.02) | ||
| Change at week 28 | −4.88 (0.23) | −3.34 (0.24) | −3.39 (0.23) | −1.54 (−2.10 to −0.98); P < 0.001 | −1.49 (−2.04 to −0.93); P < 0.001 |
| Week 52 | 9.98 (2.84) | 11.03 (3.39) | 11.14 (3.02) | ||
| Change at week 52 | −4.58 (0.27) | −3.56 (0.28) | −3.31 (0.28) | −1.02 (−1.70 to −0.34); P = 0.004 | −1.26 (−1.94 to −0.59); P < 0.001 |
| Weight, kg | |||||
| Baseline | 91.79 (22.24) | 89.77 (20.22) | 91.06 (19.71) | ||
| Week 28 | 88.35 (20.57) | 87.62 (18.05) | 88.64 (18.89) | ||
| Change at week 28 | −3.55 (0.29) | −1.56 (0.29) | −2.22 (0.28) | −2.00 (−2.79 to −1.20); P < 0.001 | −1.33 (−2.12 to −0.55); P < 0.001 |
| Week 52 | 89.44 (20.99) | 89.69 (18.00) | 89.49 (16.85) | ||
| Change at week 52 | −3.31 (0.38) | −1.51 (0.40) | −2.28 (0.39) | −1.80 (−2.87 to −0.73); P < 0.001 | −1.02 (−2.08 to 0.03); P = 0.057 |
| Weight loss ≥5% | |||||
| Week 28 | 77 (33.8; 27.6–39.9) | 36 (15.9; 11.1–20.6) | 49 (21.3; 16.0–26.6) | 17.9; P < 0.001 | 12.5; P = 0.003 |
| Week 52 | 70 (30.7; 24.7–36.7) | 32 (14.1; 9.6–18.6) | 49 (21.3; 16.0–26.6) | 16.6; P < 0.001 | 9.4; P = 0.022 |
| SBP, mmHg | |||||
| Baseline | 130.1 (12.7) | 129.1 (13.1) | 130.0 (12.9) | ||
| Week 28 | 126.5 (13.0) | 129.2 (12.6) | 128.4 (13.7) | ||
| Change at week 28 | −4.3 (0.8) | −1.2 (0.8) | −1.8 (0.8) | −3.0 (−5.2 to −0.9); P = 0.005 | −2.4 (−4.5 to −0.4); P = 0.022 |
| Week 52 | 126.5 (12.6) | 130.2 (12.9) | 127.8 (14.0) | ||
| Change at week 52 | −4.5 (0.8) | −0.7 (0.9) | −2.7 (0.8) | −3.9 (−6.1 to −1.7); P < 0.001 | −1.8 (−3.9 to 0.3); P = 0.100 |
Data exclude measurements after the initiation of rescue therapy with the exception of SBP. For HbA1c (%), HbA1c (mmol/mol), FPG (mmol/L), 2-h PPG (mmol/L), weight (kg), and SBP (mmHg), baseline, week 28, and week 52 data are mean (SD), change at week 28 and week 52 data are LSM (SE), and difference data are LSM (95% CI). For HbA1c <7%, HbA1c ≤6.5%, and weight loss ≥5%, week 28 and week 52 data are n (%; binomial CIs), and difference data are percent. To convert FPG or 2-h PPG from mmol/L to mg/dL, divide by 0.0555.
*<53 mmol/mol.
†<48 mmol/mol.