Table 1.
Empagliflozin Monotherapy versus Placebo: Results from the EMPA-REGMONO Trial at Week 24
| Efficacy results | Empagliflozin 10 mg (N = 224) |
Empagliflozin 25 mg (N = 224) |
Placebo (N = 228) |
|---|---|---|---|
| HbA1c levela | |||
| Baseline, mean, % | 7.9 | 7.9 | 7.9 |
| Change from baseline, adjusted mean, % | −0.7 | −0.8 | 0.1 |
| Difference from placebo, adjusted mean, % | −0.7 (97.5% CI, −0.9 to −0.6) | −0.9 (97.5% CI, −1.0 to −0.7) | — |
| Patients achieving an HbA1c <7%, N (%) | 72 (35) | 88 (44) | 25 (12) |
| Fasting plasma glucoseb | |||
| Baseline, mean, mg/dL | 153 | 153 | 155 |
| Change from baseline, adjusted mean, mg/dL | −19 | −25 | 12 |
| Difference from placebo, adjusted mean, mg/dL | −31 (95% CI, −37 to −26) | −36 (95% CI, −42 to −31) | — |
| Body weight | |||
| Baseline, mean, kg | 78 | 78 | 78 |
| Change from baseline, adjusted mean, % | −2.8 | −3.2 | −0.4 |
| Difference from placebo, adjusted mean, kg | −2.5 (95% CI, −3.1 to −1.9) | −2.8 (95% CI, −3.4 to −2.2) | — |
a
Modified intent-to-treat population.
b
N = 223 for empagliflozin 10 mg, N = 223 for empagliflozin 25 mg, and N = 226 for placebo.
CI indicates confidence interval; FPG, fasting plasma glucose; HbA1c, glycated hemoglobin.
Sources: Jardiance (empagliflozin) tablets prescribing information; August 2014; Roden M, et al; for the EMPA-REGMONO Trial Investigators. Lancet Diabetes Endocrinol. 2013;1:208–219.