| Lavalle- González (2013) | Randomized Double-blind Parallel-group Placebo- and Active- controlled | 1284 T2DM (605M; 679F) | MET and SU Dose Titration/Stabilization/ Washout Period: up to 10 weeks (if applicable)
Single-blind, Placebo Run-in Period: 2 weeks
Double-blind, Placebo- and Active-controlled Treatment Period I: 26 weeks
Group A: placebo daily
Group B: SITA 100 mg daily
Group C: CANA 100 mg daily
Group D: CANA 300 mg daily
Double-blind, Active-controlled Treatment Period II: 26 weeks (Groups B-D remained the same. Group A (placebo) switched to SITA 100 mg daily)
Follow-up Period: 4 weeks | HbA1C (%) at 26 Weeks | |||
| Baseline Mean ± SD | LS Mean Change ± SE | Difference vs. PBO (95% CI) | |||||
| PBO (N = 183) | 8.0 ± 0.9 | −0.17 ± 0.06 | - | ||||
| SITA 100 mg (N = 366) | 7.9 ± 0.9 | −0.82 ± 0.04 | −0.66† (−0.80, −0.52) | ||||
| CANA 100 mg (N = 368) | 7.9 ± 0.9 | −0.79 ± 0.04 | −0.62* (−0.76, −0.48) | ||||
| CANA 300 mg (N = 367) | 7.9 ± 0.9 | −0.94 ± 0.04 | −0.77* (−0.91, −0.64) | ||||
| *p < 0.001 vs. PBO | |||||||
| †Statistical comparison vs. PBO not performed (not pre-specified) | |||||||
| FPG (mg/dL) at 26 Weeks | |||||||
| Baseline Mean ± SD | LS Mean Change ± SE | Difference vs. PBO (95% CI) | |||||
| PBO (N = 183) | 164.0 ± 37.8 | 1.8 ± 1.8 | - | ||||
| SITA 100 mg (N = 366) | 169.4 ± 41.4 | −19.8 ± 1.8 | −23.4† (−28.8, −16.2) | ||||
| CANA 100 mg (N = 368) | 167.6 ± 41.4 | −27.0 ± 1.8 | −30.6* (−36.0, −23.4) | ||||
| CANA 300 mg (N = 367) | 173.0 ± 45.0 | −37.8 ± 1.8 | −39.6* (−46.8, −34.2) | ||||
| *p < 0.001 vs. PBO | |||||||
| †Statistical comparison vs. PBO not performed (not pre-specified) | |||||||
| Body Weight (kg) at 26 Weeks | |||||||
| Baseline Mean ± SD | LS Mean Percent Change ± SE | Difference vs. PBO (95% CI) | |||||
| PBO (N = 183) | 86.6 ± 22.4 | −1.2 ± 0.3 | - | ||||
| SITA 100 mg (N = 366) | 87.7 ± 21.6 | −1.2 ± 0.2 | 0.0† (−0.6, 0.6) | ||||
| CANA 100 mg (N = 368) | 88.8 ± 22.2 | −3.7 ± 0.2 | −2.5* (−3.1, −1.9) | ||||
| CANA 300 mg (N = 367) | 85.4 ± 20.9 | −4.2 ± 0.2 | −2.9* (−3.5, −2.3) | ||||
| *p < 0.001 vs. PBO | |||||||
| †Statistical comparison vs. PBO not performed (not pre-specified) | |||||||
| HbA1C (%) at 52 Weeks | |||||||
| Baseline Mean ± SD | LS Mean Change ± SE | Difference vs. SITA (95% CI) | |||||
| SITA 100 mg (N = 366) | 7.9 ± 0.9 | −0.73 ± 0.05 | - | ||||
| CANA 100 mg (N = 368) | 7.9 ± 0.9 | −0.73 ± 0.05 | 0.00 (−0.12, 0.12) | ||||