Table 2 Summary of efficacy results at week 76
Placebo (n = 228) | Empagliflozin 10 mg (n = 224) | Empagliflozin 25 mg (n = 224) | Sitagliptin 100 mg (n = 223) | |
|---|---|---|---|---|
HbA1c at week 76 (%) | 8.01 ± 0.06 | 7.22 ± 0.06 | 7.12 ± 0.06 | 7.34 ± 0.06 |
Change from baseline | 0.13 ± 0.06 | −0.65 ± 0.06 | −0.76 ± 0.06 | −0.53 ± 0.06 |
Difference vs. placebo (95 % CI) | −0.78 (−0.94, −0.63) | −0.89 (−1.04, −0.73) | −0.66 (−0.82, −0.51) | |
p value | <0.001 | <0.001 | <0.001 | |
Difference vs. sitagliptin (95 % CI) | −0.12 (−0.28, 0.04) | −0.22 (−0.38, −0.07) | ||
p value | 0.131 | 0.005 | ||
FPG at week 76 (mmol/l) | 9.2 ± 0.1 | 7.5 ± 0.1 | 7.3 ± 0.1 | 8.3 ± 0.1 |
Change from baseline | 0.8 ± 0.1 | −1.0 ± 0.1 | −1.1 ± 0.1 | −0.1 ± 0.1 |
Difference vs. placebo (95 % CI) | −1.8 (−2.1, −1.4) | −1.9 (−2.3, −1.6) | −0.9 (−1.2, −0.6) | |
p value | <0.001 | <0.001 | <0.001 | |
Difference vs. sitagliptin (95 % CI) | −0.9 (−1.2, −0.5) | −1.0 (−1.4, −0.7) | ||
p value | <0.001 | <0.001 | ||
Body weight at week 76 (kg) | 78.0 ± 0.2 | 76.2 ± 0.2 | 76.0 ± 0.2 | 78.5 ± 0.2 |
Change from baseline | −0.4 ± 0.2 | −2.2 ± 0.2 | −2.5 ± 0.2 | 0.1 ± 0.2 |
Difference vs. placebo (95 % CI) | −1.8 (−2.4, −1.3) | −2.0 (−2.6, −1.5) | 0.5 (0.0, 1.1) | |
p value | <0.001 | <0.001 | 0.055 | |
Difference vs. sitagliptin (95 % CI) | −2.3 (−2.9, −1.8) | −2.6 (−3.1, −2.0) | ||
p value | <0.001 | <0.001 | ||
SBP at week 76 (mmHg) | 130.7 ± 0.8 | 127.3 ± 0.8 | 127.3 ± 0.8 | 131.1 ± 0.8 |
Change from baseline | −0.7 ± 0.8 | −4.1 ± 0.8 | −4.2 ± 0.8 | −0.3 ± 0.8 |
Difference vs. placebo (95 % CI) | −3.4 (−5.5, −1.2) | −3.4 (−5.6, −1.2) | 0.4 (−1.8, 2.6) | |
p value | 0.003 | 0.002 | 0.724 | |
Difference vs. sitagliptin (95 % CI) | −3.7 (−5.9, −1.6) | −3.8 (−6.0, −1.6) | ||
p value | 0.001 | 0.001 | ||
DBP at week 76 (mmHg) | 78.5 ± 0.5 | 77.5 ± 0.5 | 77.5 ± 0.5 | 79.0 ± 0.5 |
Change from baseline | −0.6 ± 0.5 | −1.6 ± 0.5 | −1.6 ± 0.5 | −0.1 ± 0.5 |
Difference vs. placebo (95 % CI) | −1.0 (−2.3, 0.4) | −1.0 (−2.4, 0.3) | 0.5 (−0.8, 1.9) | |
p value | 0.157 | 0.132 | 0.433 | |
Difference vs. sitagliptin (95 % CI) | −1.5 (−2.8, −0.2) | −1.6 (−2.9, −0.2) | ||
p value | 0.029 | 0.023 |