Group D: DAPA 10 mg + MET daily in AM

Double-blind Extension Period: to 102 weeks (refer to Bailey 2013)

^†Significant vs. PBO at α = 0.019 applying Dunnett’s adjustment

FPG (mg/dL) at 24 Weeks

Baseline Mean ± SD

Adjusted Mean Change (95% CI)

Difference vs. PBO (95% CI)

PBO (N = 137)

165.6 ± 46.3

−5.9

-

(−11.2, −0.7)

DAPA 2.5 mg (N = 137)

161.4 ± 43.1

−17.8^*†

-

(−23.1, −12.4)

DAPA 5 mg

(N = 137)

169.2 ± 49.0

−21.4^**†

-

(−26.8, −16.2)

DAPA 10 mg (N = 135)

156.0 ± 38.7

−23.4^**†

-

(−28.8, −18.0)

^*p = 0.0019

^**p < 0.0001

^†Significant after sequential testing procedure at α=0.05

Body Weight (kg) at 24 Weeks

Baseline Mean ± SD

Adjusted Mean Change (95% CI)

Difference vs. PBO

PBO (N = 137)

87.7 ± 19.2

−0.9

-

(−1.4, −0.4)

DAPA 2.5 mg (N = 137)

84.9 ± 17.8

−2.2^†

-

(−2.7, −1.8)

DAPA 5 mg

(N = 137)

84.7 ± 16.3

−3.0^†

-

(−3.5, −2.6)

DAPA 10 mg (N = 135)

86.3 ± 17.5

−2.9^†

-

(−3.3, −2.4)

^*p < 0.0001

^†Significant after sequential testing procedure at α=0.05

Ferrannini

(2010)

Randomized

Double-blind

Parallel-group

Placebo- controlled

Total: 558 T2DM

(276M; 282F)

Main AM Cohort:

274 T2DM (132M; 142F)

Diet/exercise Placebo Lead-in Period: 2 weeks

(1 week for patients with enrollment HbA1C 10.1% - 12%)

Double-blind Placebo Controlled Treatment Period: 24 weeks

Patients with HbA1C 7.0% - 10% entered main AM cohort groups:

Group A: placebo daily in AM

HbA1C (%) at 24 Weeks

Baseline Mean ± SD

Adjusted Mean Change (95% CI)

Difference vs. PBO

PBO (N = 75)

7.84 ± 0.87

−0.23

-

(−0.43, −0.02)

DAPA 2.5 mg (N = 65)

7.92 ± 0.90

−0.58

-

(−0.80, −0.36)

DAPA 5 mg

(N = 64)

7.86 ± 0.94

−0.77^*

-

(−0.99, −0.55)

DAPA 10 mg (N = 70)

8.01 ± 0.96

−0.89^**

-

(−1.10, −0.67)

^*p = 0.0005 vs. PBO

^**p < 0.0001 vs. PBO

FPG (mg/dL) at 24 Weeks