Body Weight (kg) at 52 Weeks | ||||||||
Baseline Mean ± SD | LS Mean Percentage Change ± SE | Difference vs. GLIM (95% CI) | ||||||
GLIM (N = 482) | 86.5 ± 19.8 | 1.0 ± 0.2 | - | |||||
CANA 100 mg (N = 483) | 86.9 ± 20.1 | −4.2 ± 0.2 | −5.2* (−5.7, −4.7) | |||||
CANA 300 mg (N = 485) | 86.6 ± 19.5 | −4.7 ± 0.2 | −5.7* (−6.2, −5.1) | |||||
*p < 0.0001 vs. GLIM | ||||||||
Inagaki (2013) | Randomized Double-blind Placebo- controlled | 382 T2DM (260M; 122F) | Washout Period: 8 weeks Single-blind Run-in Period: 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 daily
Follow-up Visit: 2 weeks | HbA1C (%) at 12 Weeks | ||||
Baseline Mean ± SD | Adjusted Mean Change | Difference vs. PBO | ||||||
PBO (N = 75) | 7.99 ± 0.77 | 0.11 | - | |||||
CANA 50 mg (N = 82) | 8.13 ± 0.78 | −0.61* | - | |||||
CANA 100 mg (N = 74) | 8.05 ± 0.86 | −0.80*† | - | |||||
CANA 200 mg (N = 76) | 8.11 ± 0.88 | −0.79*† | - | |||||
CANA 300 mg (N = 75) | 8.17 ± 0.81 | −0.88*† | - | |||||
*p < 0.01 vs. PBO | ||||||||
†p < 0.05 vs. CANA 50 mg | ||||||||
FPG (mg/dL) at 12 Weeks | ||||||||
Baseline Mean ± SD | Adjusted Mean Change | Difference vs. PBO | ||||||
PBO (N = 75) | 170.7 ± 31.9 | −3 | - | |||||
CANA 50 mg (N = 82) | 161.4 ± 34.6 | −24.7* | - | |||||
CANA 100 mg (N = 74) | 161.0 ± 32.1 | −33.1*† | - | |||||
CANA 200 mg (N = 76) | 165.9 ± 31.4 | −36.1*† | - | |||||
CANA 300 mg (N = 75) | 169.1 ± 34.2 | −38.3*† | - | |||||
*p < 0.01 vs. PBO | ||||||||
†p < 0.01 vs. CANA 50 mg | ||||||||
Body Weight (kg) at 12 Weeks | ||||||||
Baseline Mean ± SD | Adjusted Mean Change | Difference vs. PBO | ||||||
PBO (N = 75) | 72.56 ± 15.36 | −0.78 | - | |||||
CANA 50 mg (N = 82) | 65.77 ± 13.56 | −1.98* | - | |||||
CANA 100 mg (N = 74) | 68.61 ± 14.86 | −2.51* | - | |||||
CANA 200 mg (N = 76) | 68.97 ± 14.50 | −2.39* | - | |||||
CANA 300 mg (N = 75) | 71.30 ± 12.19 | −3.19* | - | |||||
*p < 0.01 vs. PBO | ||||||||