Author

(Year)

Study Design

Subjects

Methods

Results

Wilding

(2009)

Randomized

Double-blind

Placebo-

controlled

71 T2DM

(42M; 29F)

Stabilization of Insulin Sensitizer Therapy and Insulin: ≥6 weeks with insulin treatment for ≥12 weeks

Double-blind Treatment Period: 12 weeks

Group A:

placebo daily + insulin

Group B: DAPA 10 mg daily + insulin

Group C: DAPA 20 mg daily + insulin

HbA1C (%) at 12 Weeks

Baseline Mean ± SD

Adjusted Mean Change (95% CI)

Difference vs. PBO (95% CI)

PBO (N = 23)

8.4 ± 0.9

0.03

-

(−0.2, 0.4)

DAPA 10 mg (N = 24)

8.4 ± 0.7

−0.61

−0.7

(−0.9, −0.4)

(−1.1, −0.3)

DAPA 20 mg (N = 24)

8.5 ± 0.9

−0.69

−0.78

(−0.9, −0.4)

(−1.2, −0.4)

FPG (mg/dL) at 12 Weeks

Baseline Mean ± SD

Adjusted Mean Change (95% CI)

Difference vs. PBO (95% CI)

PBO (N = 23)

165.9 ± 51.5

17.8

-

(1.4, 34.2)

DAPA 10 mg (N = 24)

156.0 ± 39.0

2.4

−15.4

(−13.6, 18.3)

(−38.4, 7.5)

DAPA 20 mg (N = 24)

161.6 ± 55.0

−9.6

−27.4

(−25.6, 6.3)

(−50.3, −4.6)

Body Weight (kg) at 12 Weeks

Baseline Mean ± SD

Adjusted Mean Change (95% CI)

Difference vs. PBO

(95% CI)

PBO (N = 23)

101.8 ± 16.5

−1.9

-

(−2.9, −0.9)

DAPA 10 mg (N = 24)

103.4 ± 10.2

−4.5

−2.6

(−5.5, −3.5)

(−4.0, −1.2)

DAPA 20 mg (N = 24)

101.2 ± 15.3

−4.3

−2.4

(−5.3, −3.3)

(−3.8, −1.0)

Bailey

(2010)

Randomized

Double-blind

Parallel Group

Placebo- Controlled

546 T2DM

(292M; 254F)

Single-blind, Placebo Lead-in Period : 2 weeks

Double-blind Treatment Period: 24 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

HbA1C (%) at 24 Weeks

Baseline Mean ± SD

Adjusted Mean Change (95% CI)

Difference vs. PBO (95% CI)

PBO (N = 137)

8.11 ± 0.96

−0.3

-

(−0.44, −0.16)

DAPA 2.5 mg (N = 137)

7.99 ± 0.90

−0.67*†

-

(−0.81, −0.53)

DAPA 5 mg (N = 137)

8.17 ± 0.96

−0.70**†

-

(−0.85, −0.56)

DAPA 10 mg (N = 135)

7.92 ± 0.82

−0.84**†

-

(−0.98, −0.70)

*p = 0.0002

**p < 0.0001