Author

(Year)

Study Design

Subjects

Methods

Results

Ferrannini

(2013)

Randomized

Double-blind

Placebo-

controlled

406 T2DM

(211M; 195F)

Screening Period: up to 1 week (2 visits)

Oral AHA Washout Period (if applicable): 4 weeks

Open-label Placebo Run-in Period: 2 weeks

Double-blind

Treatment Period: 12 weeks

Group A:

placebo once daily

Group B: EMPA 5 mg once daily

Group C: EMPA10 mg once daily

Group D: EMPA 25 mg once daily

Group E: Open-label MET (up to 1000 mg twice daily or

maximum tolerated dose)

Follow-up Visit:

4 - 7 days after last treatment

HbA1C (%) at 12 Weeks

Baseline Mean ± SD

Adjusted Mean Change

Difference vs. PBO

(95% CI)

(95% CI)

PBO

7.8 ± 0.8

0.1

-

(N = 82)

(−0.09, 0.27)

EMPA 5 mg

7.9 ± 0.8

0.4*

-

(N = 81)

(−0.61, −0.25)

EMPA 10 mg

8.0 ± 0.8

−0.5*

-

−81

(−0.66, −0.30)

EMPA 25 mg

7.8 ± 0.8

−0.6*

-

(N = 82)

(−0.81, −0.45)

MET

8.1 ± 0.9

−0.7*

-

(N = 80)

(−0.92, −0.57)

*p < 0.0001 vs. PBO

FPG (mg/dL) at 12 Weeks

Baseline Mean ± SD

Adjusted Mean Change

Difference vs. PBO

(95% CI)

(95% CI)

PBO

171.2 ± 39.6

0.7

-

(N = 82)

(−6.3, 7.7)

EMPA 5 mg

178.4 ± 45.0

−23.2*

-

(N = 81)

(−30.5, −16.2)

EMPA 10 mg

178.4 ± 46.8

−29.0*

-

−81

(−36.0, −21.8)

EMPA 25 mg

171.2 ± 25.2

−31.0*

-

(N = 82)

(−38.2, −24.1)

MET

176.6 ± 43.2

−29.9*

-

(N = 80)

(−38.0, −21.8)

Body Weight (kg) at 12 Weeks

Baseline Mean

Adjusted Mean Change

Difference vs. PBO

(95% CI)

(95% CI)

PBO

82.2

−0.75

-

(N = 82)

(−1.26, −0.23)

EMPA 5 mg

82.8

−1.81

-

(N = 81)

(−2.32, −1.29)

EMPA 10 mg

76.8

−2.33

-

−81

(−2.84, −1.82)

EMPA 25 mg

81.2

−2.03

-

(N = 82)

(−2.54, −1.52)

MET

81.1

−1.32

-

(N = 80)

(−1.84, −0.81)