Introduction
Methods
Study Design
Endpoints
Statistical Analyses
Compliance with Ethics
Results
Patient Disposition and Baseline Characteristics
GLIM (n = 482) | CANA 100 mg (n = 483) | CANA 300 mg (n = 485) | |
---|---|---|---|
Sex, n (%) | |||
Male | 263 (55) | 252 (52) | 241 (50) |
Female | 219 (45) | 231 (48) | 244 (50) |
Mean ± SD age (years) | 56.3 ± 9.0 | 56.4 ± 9.5 | 55.8 ± 9.2 |
Race, n (%) | |||
White | 322 (67) | 323 (67) | 333 (69) |
Black/African American | 22 (5) | 20 (4) | 18 (4) |
Asian | 93 (19) | 99 (21) | 93 (19) |
Othera
| 45 (9) | 41 (8) | 41 (8) |
Mean ± SD body weight (kg) | 86.5 ± 19.8 | 86.9 ± 20.1 | 86.6 ± 19.5 |
Mean ± SD body mass index (kg/m2) | 30.9 ± 5.5 | 31.0 ± 5.3 | 31.2 ± 5.4 |
Mean ± SD HbA1c (%) | 7.8 ± 0.8 | 7.8 ± 0.8 | 7.8 ± 0.8 |
Mean ± SD duration of T2DM (years) | 6.6 ± 5.0 | 6.5 ± 5.5 | 6.7 ± 5.5 |
Efficacy
Week 52 [7] | Week 104 [8] | |||||
---|---|---|---|---|---|---|
GLIM | CANA 100 mg | CANA 300 mg | GLIM | CANA 100 mg | CANA 300 mg | |
LS mean change in HbA1c (%) | –0.81 | –0.82 | –0.93 | –0.55 | –0.65 | –0.74 |
Difference vs GLIM (95% CI) | –0.01 (–0.11, 0.09) | –0.12 (–0.22, –0.02) | –0.09 (–0.20, 0.01) | –0.18 (–0.29, –0.08) | ||
LS mean % change in body weight | 1.0 | –4.2 | –4.7 | 0.9 | –4.1 | –4.2 |
Difference vs GLIM (95% CI) | –5.2 (–5.7, –4.7)a
| –5.7 (–6.2, –5.1)a
| –5.1 (–5.6, –4.5) | –5.2 (–5.7, –4.6) | ||
LS mean change in body weight (kg) | 0.7 | –3.7 | –4.0 | 0.8 | –3.6 | –3.6 |
Difference vs GLIM (95% CI) | –4.4 (–4.8, –3.9) | –4.7 (–5.2, –4.3) | –4.3 (–4.8, –3.8) | –4.4 (–4.9, –3.9) |
GLIM (n = 474) | CANA 100 mg (n = 478) | CANA 300 mg (n = 474) | |
---|---|---|---|
Week 52 | |||
Patients, n (%) | 127 (26.8) | 346 (72.4) | 372 (78.5) |
Difference vs GLIM (95% CI) | 45.6 (39.7, 51.5) | 51.7 (46.0, 57.3) | |
OR vs GLIM (95% CI) | 7.7 (5.7, 10.3) | 10.7 (7.9, 14.5) | |
Week 104 | |||
Patients, n (%) | 127 (26.8) | 313 (65.5) | 337 (71.1) |
Difference vs GLIM (95% CI) | 38.7 (32.6, 44.7) | 44.3 (38.4, 50.2) | |
OR vs GLIM (95% CI) | 5.6 (4.2, 7.5) | 7.4 (5.5, 9.8) |