Table 2.
Empagliflozin in Combination with Metformin versus Placebo plus Metformin: Results from the EMPA-REG MET Trial at Week 24
| Efficacy results | Empagliflozin 10 mg + metformin (N = 217) |
Empagliflozin 25 mg + metformin (N = 213) |
Placebo (N = 207) |
|---|---|---|---|
| HbA1c levela | |||
| Baseline, mean, % | 7.9 | 7.9 | 7.9 |
| Change from baseline, adjusted mean, % | −0.7 | −0.8 | −0.1 |
| Difference from placebo plus metformin, adjusted mean, % | −0.6 (97.5% CI, −0.7 to −0.4) | −0.6 (97.5% CI, −0.8 to −0.5) | — |
| Patients achieving an HbA1c <7%, N (%) | 75 (38) | 74 (39) | 23 (13) |
| Fasting plasma glucoseb | |||
| Baseline, mean, mg/dL | 155 | 149 | 156 |
| Change from baseline, adjusted mean, mg/dL | −20 | −22 | 6 |
| Difference from placebo, adjusted mean, mg/dL | −26 | −29 | — |
| Body weight | |||
| Baseline, mean, kg | 82 | 82 | 80 |
| Change from baseline, adjusted mean, % | −2.5 | −2.9 | −0.5 |
| Difference from placebo, adjusted mean, kg | −2.0 (95% CI, −2.6 to −1.4) | −2.5 (95% CI, −3.1 to −1.9) | — |
a
Modified intent-to-treat population.
b
N = 216 for empagliflozin 10 mg, N = 213 for empagliflozin 25 mg, and N = 207 for placebo.
CI indicates confidence interval; FPG, fasting plasma glucose; HbA1c, glycated hemoglobin.
Sources: Jardiance (empagliflozin) tablets prescribing information; August 2014; Häring H-U, et al; for the EMPA-REG MET Trial Investigators. Diabetes Care. 2014;37:1650–1659.