Baseline Mean ± SD

Adjusted Mean Change ± SE

Difference vs. PBO

PBO

86.4 ± 21.3

1.64 ± 0.28

-

(N = 139)

DAPA 5 mg

87.8 ± 20.7

0.09 ± 0.28^*

-

(N = 141)

DAPA 10 mg

84.8 ± 22.2

−0.14 ± 0.28^*

-

(N = 140)

^*p < 0.0001 vs. PBO

HbA1C (%) at 48 Weeks

Baseline Mean ± SD

Adjusted Mean Change

(95% CI)

Difference vs. PBO

PBO

8.34 ± 1.00

−0.54

-

(N = 139)

(−0.70, −0.38)

DAPA 5 mg

8.40 ± 1.03

−0.95

-

(N = 141)

(−1.10, −0.80)

DAPA 10 mg

8.37 ± 0.96

−1.21

-

(N = 140)

(−1.36, −1.06)

FPG (mg/dL) at 48 Weeks

Baseline Mean ± SD

Adjusted Mean Change

(95% CI)

Difference vs. PBO

PBO

160.7 ± 47.0

−13.1

-

(N = 139)

(−20.2, −6.0)

DAPA 5 mg

168.6 ± 52.1

−22.8

-

(N = 141)

(−29.1 to −16.4)

DAPA 10 mg

164.9 ± 46.3

−33.1

-

(N = 140)

(−39.0, −27.2)

Body Weight (kg) at 48 Weeks

Baseline Mean ± SD

Adjusted Mean Change

(95% CI)

Difference vs. PBO

PBO

86.4 ± 21.3

2.99

-

(N = 139)

(2.19, 3.79)

DAPA 5 mg

87.8 ± 20.7

1.35

-

(N = 141)

(0.61, 2.09)

DAPA 10 mg

84.8 ± 22.2

0.69

-

(N = 140)

(−0.03, 1.41)

Wilding

(2012)

Randomized

Double-blind

Parallel-group

Placebo- controlled

800 T2DM

(382M; 418F)

Pre-enrollment OAD/

Insulin Stabilization Period: at least 8 weeks

Enrollment Period: 2 weeks

HbA1C (%) at 24 Weeks

Baseline Mean ± SD

Adjusted Mean Change

Difference vs. PBO

(95% CI)

PBO

8.47 ± 0.77

−0.39

-

(N = 193)

DAPA 2.5 mg

8.46 ± 0.78

−0.79

−0.40^*

(N = 202)

(−0.54, −0.25)