CANA 300 mg (N = 367) | 7.9 ± 0.9 | −0.88 ± 0.05 | −0.15 (−0.27, −0.03) | ||||
FPG (mg/dL) at 52 Weeks | |||||||
Baseline Mean ± SD | LS Mean Change ± SE | Difference vs. SITA (95% CI) | |||||
SITA 100 mg (N = 366) | 167.6 ± 41.4 | −18.0 ± 1.8 | - | ||||
CANA 100 mg (N = 368) | 169.4 ± 41.4 | −27.0 ± 1.8 | −9.0* (−12.6, −3.6) | ||||
CANA 300 mg (N = 367) | 173.0 ± 45.0 | −36.0 ± 1.8 | −18.0* (−21.6, −12.6) | ||||
*p < 0.001 vs. SITA | |||||||
Body Weight (kg) at 52 Weeks | |||||||
Baseline Mean ± SD | LS Mean Percent Change ± SE | Difference vs. SITA (95% CI) | |||||
SITA 100 mg (N = 355) | 87.7 ± 21.6 | −1.3 ± 0.2 | - | ||||
CANA 100 mg (N = 365) | 88.8 ± 22.2 | −3.8 ± 0.2 | −2.4* (−3.0, −1.8) | ||||
CANA 300 mg (N = 360) | 85.4 ± 20.9 | −4.2 ± 0.2 | −2.9* (−3.4, −2.3) | ||||
*p < 0.001 vs. SITA | |||||||
Schernthaner (2013) | Randomized Double-blind Active- controlled | 755 T2DM (422M; 333F) | MET and SU Adjustment Period (if applicable): up to 12 weeks (Including an 8-week dose-stable period)
Single-blind, Placebo Run-in Period: 2 weeks
Double-blind Treatment Period: 52 weeks
Group A: SITA 100 mg daily
Group B: CANA 300 mg daily
Follow-up Period: 4 weeks | HbA1C (%) at 52 Weeks | |||
Baseline Mean ± SD | LS Mean Change | Difference vs. SITA (95% CI) | |||||
SITA 100 mg (N = 378) | 8.1 ± 0.9 | −0.66 | - | ||||
CANA 300 mg (N = 377) | 8.1 ± 0.9 | −1.03 | −0.37 (−0.50, −0.25) | ||||
FPG (mg/dL) at 52 Weeks | |||||||
Baseline Mean | LS Mean Change | Difference vs. SITA | |||||
SITA 100 mg (N = 378) | 165.8 ± 44.9 | −5.9 | - | ||||
CANA 300 mg (N = 377) | 169.4 ± 42.4 | −29.9 | −24.1* | ||||
*p < 0.001 vs. SITA | |||||||
Body Weight (kg) at 52 Weeks | |||||||
Baseline Mean | LS Mean Percent Change | Difference vs. SITA (95% CI) | |||||
SITA (N = 378) | 89.1 ± 23.2 | 0.3 | - | ||||
CANA 300 mg (N = 377) | 87.4 ± 23.2 | −2.5 | −2.8* | ||||
*p < 0.001 vs. SITA |