Baseline Mean ± SD

Adjusted Mean Change

(95% CI)

Difference vs. PBO

PBO

170.6 ± 57.2

-

-

(N = 193)

DAPA 2.5 mg

180.1 ± 59.9

−12.43^*

-

(N = 202)

(−23.1, −2.0)

DAPA 5 mg

185.4 ± 58.7

−16.2^*

-

(N = 211)

(−26.7, −6.0)

DAPA 10 mg

173.1 ± 54.9

−16.94^*

-

(N = 194)

(−27.6, −6.5)

^*p < 0.001 vs. baseline

Body Weight (kg) at 48 Weeks

Baseline Mean ± SD

Adjusted Mean Change

Difference vs. PBO

(95% CI)

PBO

94.5 ± 19.8

0.82

-

(N = 193)

DAPA 2.5 mg

93.0 ± 16.7

−0.96

−1.78^*

(N = 202)

(−2.53, −1.03)

DAPA 5 mg

93.3 ± 17.4

−1

−1.82^*

(N = 211)

(−2.56, −1.07)

DAPA 10 mg

94.5 ± 16.8

−1.61

−2.43^*

(N = 194)

(−3.18, −1.68)

^*p < 0.001 vs. PBO

Bailey

(2013)

Randomized

Double-blind

Parallel Group

Placebo- Controlled

546 T2DM

(292M; 254F)

Double-blind

Extension Treatment Period: 78 weeks

(All groups on stable MET dose)

Group A: placebo + MET daily in AM

Group B: DAPA 2.5 mg + MET daily in AM

Group C: DAPA 5 mg + MET daily in AM

Group D: DAPA 10 mg + MET daily in AM

HbA1C (%) at 102 Weeks

Baseline Mean ± SD

Adjusted Mean Change

(95% CI)

Difference vs. PBO

(95% CI)

PBO

8.12 ± 0.96

0.02

-

(N = 137)

(−0.20, 0.23)

DAPA 2.5 mg

7.99 ± 0.90

−0.48

−0.50^*

(N = 137)

(−0.68, −0.29)

(−0.79, −0.21)

DAPA 5 mg

8.17 ± 0.96

−0.58

−0.60^**

(N = 137)

(−0.77, −0.39)

(−0.89, −0.31)

DAPA 10 mg

7.92 ± 0.82

−0.78

−0.80^**

(N = 135)

(−0.97, −0.60)

(−1.08, −0.52)

^*p = 0.0008

^**p < 0.0001 vs. PBO

FPG (mg/dL) at 102 Weeks

Baseline Mean ± SD

Adjusted Mean Change

(95% CI)

Difference vs. PBO

(95% CI)

PBO

165.6± 46.5

−10.5

-

(N = 137)

(−17.5, −3.4)

DAPA 2.5 mg

161.4 ± 43.1

−19.3

−8.8^*