(N = 137)

(−25.6, −13.0)

(−17.8, 0.2)

DAPA 5 mg

169.2 ± 49.0

−26.5

−16.0^**

(N = 137)

(−32.1, −20.9)

(−24.7, −7.4)

DAPA 10 mg

156.0 ± 38.7

−24.5

−14.1^***

(N = 135)

(−29.7, −19.3)

(−22.5, −5.6)

^*p = 0.0518 vs. PBO

^**p = 0.0003 vs. PBO

^***p = 0.0012 vs. PBO

Body Weight (kg) at 102 Weeks

Baseline Mean ± SD

Adjusted Mean Change

(95% CI)

Difference vs. PBO

(95% CI)

PBO

87.74 ± 19.24

1.36

-

(N = 137)

(0.53, 2.20)

DAPA 2.5 mg

84.90 ± 17.77

−1.1

−2.46^*

(N = 137)

(−1.91, −0.29)

(−3.63, −1.30)

DAPA 5 mg

84.73 ± 16.26

−1.7

−3.06^*

(N = 137)

(−2.48, −0.91)

(−4.21, −1.92)

DAPA 10 mg

86.28 ± 17.53

−1.74

−3.10^*

(N = 135)

(−2.51, −0.96)

(−4.24, −1.96)

^*p < 0.0001 vs. PBO

Kaku

(2013)

Randomized

Double-blind

Parallel-group

Placebo- controlled

279 T2DM

(215M; 64F)

Washout Period:

6 weeks if on prior OAD

Single-blind Placebo Lead-in Period: 4 weeks

Double-blind

Treatment Period:

12 weeks

Group A: placebo daily

Group B: DAPA 1 mg daily

Group C: DAPA 2.5 mg daily

Group D: DAPA 5 mg daily

Group E: DAPA 10 mg daily

Follow-up Period:

4 weeks

HbA1C (%) at 12 Weeks

Baseline Mean ± SD

Adjusted Mean Change ± SE

Difference vs. PBO

(95% CI)

PBO

8.12 ± 0.71

0.37 ± 0.07

-

(N = 54)

DAPA 1 mg

8.10 ± 0.79

−0.12 ± 0.07

−0.49^*

(N = 59)

(−0.68, −0.29)

DAPA 2.5 mg

7.92 ± 0.74

−0.11 ± 0.07

−0.48^*

(N = 56)

(−0.67, −0.28)

DAPA 5 mg

8.05 ± 0.66

−0.37 ± 0.07

−0.74^*

(N = 58)

(−0.93, −0.54)

DAPA 10 mg

8.18 ± 0.69

−0.44 ± 0.07

−0.80^*

(N = 52)

(−1.00, −0.61)

^*p < 0.0001 vs. PBO (tested at α = 0.015 applying Dunnett adjustment

FPG (mg/dL) at 12 Weeks

Baseline Mean ± SD

Adjusted Mean Change ± SE

Difference vs. PBO

PBO

158.94 ± 31.08

11.17 ± 3.43

-

(N = 54)

DAPA 1 mg

163.53 ± 33.06

−15.61 ± 3.43^*

-

(N = 59)

DAPA 2.5 mg

159.17 ± 31.98

−19.83 ± 3.37^*

-

(N = 56)