Group B: DAPA 5 mg + MET XR combination with evening meal

Group C: DAPA 5 mg + placebo combination with evening meal

Study II:

Group A: MET XR + placebo combination with evening meal

Group B: DAPA 10 mg + MET XR combination with evening meal

Group C: DAPA 10 mg + placebo combination with evening meal

DAPA 5 mg + PBO

(N = 203)

9.1 ± 1.4

−1.19

(−1.36, −1.02)

-

HbA1C (%) at 24 Weeks - Study II

Baseline Mean ± SD

Adjusted Mean Change

(95% CI)

Difference vs. Monotherapy

(95% CI)

MET + PBO

9.1 ± 1.3

−1.44

-

(N = 208)

(−1.59, −1.29)

DAPA 10 mg + MET

(N = 211)

9.1 ± 1.3

−1.98

(−2.13, −1.83)

−0.53*

(−0.74, −0.32)

−0.54**

(−0.75, −0.33)

DAPA 10 mg + PBO

(N = 219)

9.1 ± 1.3

−1.45

(−1.59, −1.31)

-

*p < 0.0001 vs. DAPA + PBO

**p < 0.0001 vs. MET + PBO

FPG (mg/dL) at 24 Weeks - Study I

Baseline Mean ± SD

Adjusted Mean Change

(95% CI)

Difference vs. Monotherapy

(95% CI)

MET + PBO

197.1 ± 60.4

−33.5

-

(N = 201)

(−38.9, −28.3)

DAPA 5 mg + MET

(N = 194)

193.9 ± 56.2

−61.1

(−66.5, −55.7)

−19.1*

(−26.7, −11.4)

−27.6**

(−35.1, −19.8)

DAPA 5 mg + PBO

(N = 203)

190.8 ± 56.6

−42

(−47.4, −36.8)

-

FPG (mg/dL) at 24 Weeks - Study II

Baseline Mean ± SD

Adjusted Mean Change

(95% CI)

Difference vs. Monotherapy

(95% CI)

MET + PBO

(N = 208)

190.5 ± 54.1

−34.8

(−39.8, −29.7)

-

DAPA 10 mg + MET

(N = 211)

189.5 ± 58.0

−60.4

(−65.2, −55.3)

−13.9*

(−20.9, −7.0)

−25.6**

(−32.6, −18.6)

DAPA 10 mg + PBO

(N = 219)

198.0 ± 61.8

−46.5

(−51.4, −41.4)

-

*p < 0.0001 vs. DAPA + PBO (after sequential testing procedure at α = 0.05)

**p < 0.0001 vs. MET + PBO (after sequential testing procedure at α = 0.05)

Body Weight (kg) at 24 Weeks - Study I

Baseline Mean ± SD

Adjusted Mean Change

(95% CI)

Difference vs. Monotherapy

(95% CI)