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. 2015 May 5;11:739–749. doi: 10.2147/TCRM.S71762

Table 1.

Clinical trials with empagliflozin

Study Treatment Duration Drug/placebo HbA1c (%) HbA1c <7% at the end of treatment (%) FPG (mmol/L) Body weight (kg) Systolic blood pressure Diastolic blood pressure
Heise et al17 1. Empagliflozin 10 mg, 25 mg, 100 mg
2. Placebo
28 days 52/16 −0.4#,§ −2.4**,#,§ −1.5#,§
Heise et al18 1. Empagliflozin 2.5 mg, 10 mg, 25 mg, 100 mg
2. Placebo
8 days 36/12 −2.2*,#,§
Kadowaki et al22 1. Empagliflozin 5 mg, 10 mg, 25 mg, 50 mg
2. Placebo
12 weeks 438/109 −0.9#,,** 35# −2#,,** −2.2#,,** −4#,,* −1.6#,,*
Ferrannini et al24 1. Empagliflozin 5 mg, 10 mg, 25 mg
2. Placebo
3. Metformin
12 weeks 324/82 −0.6***,#,§ 45*,# −1.7***,#,§ −2***,#,§
Roden et al25 1. Empagliflozin 10 mg, 25 mg
2. Sitagliptin 100 mg
3. Empagliflozin 25 mg (open label)
24 weeks 448/228 −0.9#,,*** 44# −2***,#, −2***,#, −3*,#, −1.5*,#,
Nishimura et al26 1. Empagliflozin 10 mg, 25 mg
2. Placebo
4 weeks 39/21 −0.6**,#,§ −2.2#,§ −2#,§ −6#,§ −5#,§
Haring et al27 1. Empagliflozin 10 mg, 25 mg
2. Placebo
3. Metformin
24 weeks 430/207 −0.8**,#,§ 39# −1.2**,#,§ −2**,#,§ −5**,#,§ −1.6*,#,§
Rosenstock et al11 1. Empagliflozin 1 mg, 5 mg, 10 mg, 25 mg, 50 mg
2. Placebo
3. Sitagliptin 100 mg
4. Metformin
12 weeks 353/71 −0.6**,#,§ 37#,§ −1.6***,#,§ −2.9***,#,§ −3§ −2§
Kovacs et al6 1. Empagliflozin 10 mg, 25 mg
2. Placebo
3. Pioglitazone
4. +/− Metformin
24 weeks 333/165 −0.7**,#,§ 48# −1.2**,#,§ −1.6**,#,§ −4**,#,§ −2.2**,#,§
Rosenstock et al31 1. Empagliflozin 10 mg, 25 mg
2. Placebo
3. Insulin
52 weeks 275/188 −0.6**,#,§ −2.5**,#,§ −2**,#,§ −4*,#,§

Notes:

*

P<0.05 compared to the placebo.

**

P<0.001 compared to the placebo.

***

P<0.0001 compared to the placebo.

#

Maximum effect.

§

Changes from baseline to the end of treatment.

Differences vs placebo in changes from baseline.

Abbreviations: FPG, fasting plasma glucose; HbA1c, glycosylated hemoglobin.