Strojek

(2011)

Randomized

Double-blind

Parallel-group

Placebo- Controlled

592 T2DM

(285M; 307F)

Open-label, Lead in Period: 8 weeks of GLIM daily

Qualification Period: 1 week

Double-blind

Placebo-controlled Treatment Period:

24 weeks

Group A: placebo before first meal of day + GLIM

Group B: DAPA 2.5 mg daily before first meal of day + GLIM

Group C: DAPA 5 mg daily before first meal of day + GLIM

Group D: DAPA 10 mg daily before first meal of day + GLIM

Extension Period:

24 weeks

HbA1C (%) at 24 Weeks

Baseline Mean ± SD

Adjusted Mean Change

Difference vs. PBO

(95% CI)

PBO (N = 145)

8.15 ± 0.74

−0.13

-

DAPA 2.5 mg (N = 154)

8.11 ± 0.75

−0.58

−0.44*

(−0.61, −0.27)

DAPA 5 mg

(N = 142)

8.12 ± 0.78

−0.63

−0.49*

(−0.67, −0.32)

DAPA 10 mg (N = 151)

8.07 ± 0.79

−0.82

−0.68*

(−0.86, −0.51)

*p < 0.0001 vs. PBO at α = 0.019 applying Dunnett’s adjustment

FPG (mg/dL) at 24 Weeks

Baseline Mean ± SD

Adjusted Mean Change

Difference vs. PBO

(95% CI)

PBO (N = 145)

172.6 ± 37.3

−2

-

DAPA 2.5 mg (N = 154)

172.3 ± 38.4

−16.8

−15

(−21.8, −7.9)

DAPA 5 mg (N = 142)

174.4 ± 38.2

−21.3

−19.3*

(−26.3, −12.3)

DAPA 10 mg (N = 151)

172.1 ± 36.8

−28.5

−26.5*

(−33.5, −19.5)

*p < 0.0001 vs. PBO

Body Weight (kg) at 24 Weeks

Baseline Mean

Adjusted Mean Change

Difference vs. PBO

(95% CI)

PBO (N = 145)

80.94

−0.72

-

DAPA 2.5 mg (N = 154)

81.89

−1.18

−0.46*

(−1.08, 0.15)

DAPA 5 mg

(N = 142)

81

−1.56

−0.84**

(−1.47, −0.21)

DAPA 10 mg (N = 151)

80.56

−2.26

−1.54***

(−2.17, −0.92)

*p = 0.1410 vs. PBO

**p = 0.0091 vs. PBO (significant after sequential testing procedure at α = 0.05)

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

Bailey

(2012)

Randomized

Double-blind

Parallel- group

Placebo- controlled

282 T2DM

(141M; 141F)

Qualification Period: 2 weeks

Single-blind, Placebo Lead-in Period:

2 weeks

HbA1C (%) at 24 Weeks

Baseline Mean ± SD

Adjusted Mean Change

(95% CI)

Difference vs. PBO

(95% CI)

PBO (N = 68)

7.8 ± 1.12

0.02

-

(−0.22, 0.25)

DAPA 1 mg

(N = 72)

7.8 ± 0.98

−0.68

−0.69*