Author (Year)

Study Design

Subjects

Methods

Results

Rosenstock

(2012)

Randomized

Double-blind

Placebo-

controlled Parallel-group

451 T2DM

(236M; 215F)

(Stable dose of MET ≥ 3 months)

Pre-treatment Screening Period: 3 - 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 once daily

Group F: CANA 300 mg twice daily

Group G: SITA 100 mg daily

Post-treatment Period: 2 weeks

HbA1C (%) at 12 Weeks

Baseline Mean ± SD

LS Mean Change

Difference vs. PBO

PBO

(N = 65)

7.75 ± 0.83

−0.22

-

CANA 50 mg

(N = 64)

8.00 ± 0.99

−0.79^*

-

CANA 100 mg

(N = 64)

7.83 ± 0.96

−0.76^*

-

CANA 200 mg

(N = 65)

7.61 ± 0.80

−0.70^*

-

CANA 300 mg QD (N = 64)

7.69 ± 1.02

−0.92^*

-

CANA 300 mg BID (N = 64)

7.73 ± 0.89

−0.95^*

-

SITA 100 mg

7.64 ± 0.95

−0.74^*

-

^*p < 0.001 vs. PBO

FPG (mg/dL) at 12 Weeks

Baseline Mean ± SD

LS Mean Change

Difference vs. PBO

PBO

(N = 65)

164 ± 38

3.6

-

CANA 50 mg

(N = 64)

170 ± 45

−16.2^*

-

CANA 100 mg

(N = 64)

168 ± 42

−25.2^*

-

CANA 200 mg

(N = 65)

160 ± 37

−27.0^*

-

CANA 300 mg QD (N = 64)

159 ± 44

−25.2^*

-

CANA 300 mg BID (N = 64)

157 ± 34

−23.4^*

-

SITA 100 mg

158 ± 42

−12.6

-

^*p < 0.001 vs. PBO

Body Weight (kg) at 12 Weeks

Baseline Mean ± SD

LS Mean Percent Change

Difference vs. PBO

PBO

(N = 65)

85.9 ± 19.5

−1.1

-

CANA 50 mg

(N = 64)

87.6 ± 16.3

−2.3^*

-

CANA 100 mg

(N = 64)

87.7 ± 15.5

−2.6^*

-

CANA 200 mg

(N = 65)

87.7 ± 17.0

−2.7^*

-

CANA 300 mg QD (N = 64)

87.3 ± 15.9

−3.4^*

-

CANA 300 mg BID (N = 64)

86.0 ± 19.7

−3.4^*

-

SITA 100 mg

87.2 ± 18.0

−0.6

-

^*p < 0.001 vs. PBO