Group B: CANA 100 mg daily

Group C: CANA 300 mg daily

Double-blind Extension Period: 26 weeks

FPG (mg/dL) at 26 Weeks

Baseline Mean ± SD

LS Mean Change

Difference vs. PBO

(95% CI)

PBO

(N = 90)

160.4 ± 43.2

0.5

-

CANA 100 mg (N = 90)

169.4 ± 46.3

−14.9

−15.4^†

(−28.5, −2.3)

CANA 300 mg (N = 89)

158.6 ± 58.0

−11.7

−12.2^*

(−25.4, 1.0)

^*p = NS for CANA vs. PBO

^†Statistical comparison vs. PBO not performed owing to multiplicity control

Body Weight (kg) at 26 Weeks

Baseline Mean ± SD

LS Mean Percent Change

Difference vs. PBO

(95% CI)

PBO

(N = 90)

92.8 ± 17.4

0.3

-

CANA 100 mg (N = 90)

90.5 ± 18.4

−1.2

−1.6^†

(−2.3, −0.8)

CANA 300 mg (N = 89)

90.2 ± 18.1

−1.5

−1.8^†

(−2.6, −1.0)

^†Statistical comparison for CANA vs. PBO not performed (not prespecified)

Forst

(2014)

Randomized

Double-blind

Placebo- and Active-

controlled

342 T2DM

(216M; 126F)

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

Double-blind,

Placebo-Controlled Core Treatment

Period: 26 weeks

Group A:

placebo daily

Group B: CANA 100 mg daily

Group C: CANA 300 mg daily

Double-blind Active-control Extension Period: 26 weeks

Group A:

SITA 100 mg daily

Group B: CANA 100 mg daily

Group C: CANA 300 mg daily

HbA1C (%) at 26 Weeks

Baseline Mean ± SD

LS Mean Change

Difference vs. PBO

PBO/SITA

(N = 115)

8.0 ± 1.0

−0.26

-

CANA 100 mg

(N = 113)

8.0 ± 0.9

−0.89

−0.62^*

CANA 300 mg

(N = 114)

7.9 ± 0.9

−1.03

−0.76^*

^*p < 0.001 vs. PBO

FPG (mg/dL) at 26 Weeks

Baseline Mean

LS Mean Change

Difference vs. PBO

PBO/SITA

(N = 115)

164.0 ± 39.6

2.5

-

CANA 100 mg

(N = 113)

169.4 ± 39.6

−26.8

−29.4^*

CANA 300 mg

(N = 114)

164.0 ± 41.4

−33.2

−35.7^*

^*p < 0.001 vs. PBO

Body Weight (kg) at 26 Weeks

Baseline Mean ± SD

LS Mean Percent Change

Difference vs. PBO

PBO/SITA

(N = 115)

93.8 ± 22.4

−0.1

-

CANA 100 mg

(N = 113)

94.2 ± 22.2

−2.8

−2.7^*