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. 2015 Mar;8(Spec Feature):92–95.

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.