^*p < 0.001 vs. PBO

Body Weight (kg) at 26 Weeks

Baseline Mean ± SD

LS Mean Percent Change

Difference vs. PBO

(95% CI)

PBO

(N = 156)

91.2 ± 22.6

−0.7

-

CANA 100 mg (N = 157)

93.8 ± 22.6

−2.1

−1.4^*

(−2.1, −0.7)

CANA 300 mg (N = 156)

93.5 ± 22.0

−2.6

−2.0^*

(−2.7, −1.3)

^*p < 0.001 vs. PBO

HbA1C (%) at 52 Weeks

Baseline Mean ± SD

LS Mean Change

Difference vs. PBO

(95% CI)

PBO

(N = 156)

8.1 ± 0.9

0.01

-

CANA 100 mg (N = 157)

8.1 ± 0.9

−0.74

−0.75

(−0.95, −0.55)

CANA 300 mg (N = 156)

8.1 ± 0.9

−0.96

−0.97

(−1.17, −0.77)

FPG (mg/dL) at 52 Weeks

Baseline Mean ± SD

LS Mean Change

Difference vs. PBO

(95% CI)

PBO

(N = 156)

169.4 ± 39.6

10.8

-

CANA 100 mg (N = 157)

173.0 ± 41.4

−19.8

−28.8

(−37.8, −19.8)

CANA 300 mg (N = 156)

167.6 ± 37.8

−27

−37.8

(−46.8, −28.8)

Body Weight (kg) at 52 Weeks

Baseline Mean ± SD

LS Mean Percent Change

Difference vs. PBO

(95% CI)

PBO

(N = 156)

91.2 ± 22.6

−0.9

-

CANA 100 mg (N = 157)

93.8 ± 22.6

−2.2

−1.3

(−2.1, −0.5)

CANA 300 mg (N = 156)

93.5 ± 22.0

−3.2

−2.2

(−3.0, −1.4)

Yale

(2013)

Randomized

Double-blind

Placebo-

controlled

269 T2DM with chronic kidney disease

(163M; 106F)

AHA Dose Titration Period (if required): up to 4 weeks

AHA Dose Stable Period (if required): 8 weeks

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

Double-blind Core Treatment Period: 26 weeks

Group A:

placebo daily

HbA1C (%) at 26 Weeks

Baseline Mean ± SD

LS Mean Change

Difference vs. PBO

(95% CI)

PBO

(N = 90)

8.0 ± 0.9

−0.03

-

CANA 100 mg (N = 90)

7.9 ± 0.9

−0.33

−0.30^*

(−0.5, −0.1)

CANA 300 mg (N = 89)

8.0 ± 0.8

−0.44

−0.40^**

(−0.6, −0.2)

^*p < 0.05 vs. PBO

^**p < 0.001 vs. PBO