Body Weight (kg) at 52 Weeks

Baseline Mean ± SD

LS Mean Percentage Change ± SE

Difference vs. GLIM

(95% CI)

GLIM

(N = 482)

86.5 ± 19.8

1.0 ± 0.2

-

CANA 100 mg

(N = 483)

86.9 ± 20.1

−4.2 ± 0.2

−5.2*

(−5.7, −4.7)

CANA 300 mg

(N = 485)

86.6 ± 19.5

−4.7 ± 0.2

−5.7*

(−6.2, −5.1)

*p < 0.0001 vs. GLIM

Inagaki

(2013)

Randomized

Double-blind

Placebo-

controlled

382 T2DM

(260M; 122F)

Washout Period: 8 weeks

Single-blind Run-in Period: 4 weeks

Double-Blind

Treatment Period: 12 weeks

Group A:

placebo daily

Group B: CANA 50

mg daily

Group C: CANA 100

mg daily

Group D: CANA 200

mg daily

Group E: CANA 300

mg daily

Follow-up Visit: 2 weeks

HbA1C (%) at 12 Weeks

Baseline Mean ± SD

Adjusted Mean Change

Difference vs. PBO

PBO

(N = 75)

7.99 ± 0.77

0.11

-

CANA 50 mg (N = 82)

8.13 ± 0.78

−0.61*

-

CANA 100 mg (N = 74)

8.05 ± 0.86

−0.80*†

-

CANA 200 mg (N = 76)

8.11 ± 0.88

−0.79*†

-

CANA 300 mg (N = 75)

8.17 ± 0.81

−0.88*†

-

*p < 0.01 vs. PBO

p < 0.05 vs. CANA 50 mg

FPG (mg/dL) at 12 Weeks

Baseline Mean ± SD

Adjusted Mean Change

Difference vs. PBO

PBO

(N = 75)

170.7 ± 31.9

−3

-

CANA 50 mg (N = 82)

161.4 ± 34.6

−24.7*

-

CANA 100 mg (N = 74)

161.0 ± 32.1

−33.1*†

-

CANA 200 mg (N = 76)

165.9 ± 31.4

−36.1*†

-

CANA 300 mg (N = 75)

169.1 ± 34.2

−38.3*†

-

*p < 0.01 vs. PBO

p < 0.01 vs. CANA 50 mg

Body Weight (kg) at 12 Weeks

Baseline Mean ± SD

Adjusted Mean Change

Difference vs. PBO

PBO

(N = 75)

72.56 ± 15.36

−0.78

-

CANA 50 mg

(N = 82)

65.77 ± 13.56

−1.98*

-

CANA 100 mg (N = 74)

68.61 ± 14.86

−2.51*

-

CANA 200 mg (N = 76)

68.97 ± 14.50

−2.39*

-

CANA 300 mg (N = 75)

71.30 ± 12.19

−3.19*

-

*p < 0.01 vs. PBO