Double-blind

Placebo-controlled Treatment Period:

24 weeks

(with open-label insulin/existing OAD therapies)

Group A: placebo + insulin

Group B: DAPA 2.5 mg daily + insulin

Group C: DAPA 5 mg daily + insulin

Group D: DAPA 10 mg daily + insulin

Double-blind

Extension Period I:

24 weeks

Double-blind

Extension Period II: 56 weeks

DAPA 5 mg

8.62 ± 0.89

−0.89

−0.49*

(N = 211)

(−0.65, −0.34)

DAPA 10 mg

8.57 ± 0.82

−0.96

−0.57*

(N = 194)

(−0.72, −0.42)

*p < 0.001 vs. PBO

FPG (mg/dL) at 24 Weeks

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

−11.71*

-

(N = 202)

(−21.4, −2.0)

DAPA 5 mg

185.4 ± 58.7

−20.18*

-

(N = 211)

(−29.9, −10.6)

DAPA 10 mg

173.1 ± 54.9

−19.82*

-

(N = 194)

(−29.6, −10.1)

*p < 0.001 vs. baseline

Body Weight (kg) at 24 Weeks

Baseline Mean ± SD

Adjusted Mean Change

Difference vs. PBO

(95% CI)

PBO

94.5 ± 19.8

0.43

-

(N = 193)

DAPA 2.5 mg

93.0 ± 16.7

−0.92

−1.35*

(N = 202)

(−1.90, −0.80)

DAPA 5 mg

93.3 ± 17.4

−1

−1.42*

(N = 211)

(−1.97, −0.88)

DAPA 10 mg

94.5 ± 16.8

−1.61

−2.04*

(N = 194)

(−2.59, −1.48)

*p < 0.001 vs. PBO

HbA1C (%) at 48 Weeks

Baseline Mean ± SD

Adjusted Mean Change

Difference vs. PBO

(95% CI)

PBO

8.47 ± 0.77

−0.47

-

(N = 193)

DAPA 2.5 mg

8.46 ± 0.78

−0.79

−0.32*

(N = 202)

(−0.48, −0.16)

DAPA 5 mg

8.62 ± 0.89

−0.96

−0.49*

(N = 211)

(−0.65, −0.33)

DAPA 10 mg

8.57 ± 0.82

−1.01

−0.54*

(N = 194)

(−0.70, −0.38)

*p < 0.001 vs. PBO

FPG (mg/dL) at 48 Weeks