Table 2 Primary and key secondary end points (randomized patients population)
Efficacy variable | Saxagliptin + Metformin (n = 74) | Placebo + Metformin (n = 86) | Difference vs placebo |
|---|---|---|---|
HbA1c ,% | n = 74 | n = 84 | |
Baseline mean (SE) | 7.92 (0.11) | 7.97 (0.09) | |
Week 12* mean (SE) | 7.36 (0.13) | 7.75 (0.12) | |
Week 12* adjusted mean change from baseline (SE) | -0.56 (0.09) | -0.22 (0.08) | -0.34 (0.12) P = 0.006 |
FPG, mg/dL | n = 73 | n = 84 | |
Baseline mean (SE) | 164.22 (5.51) | 161.25 (4.62) | |
Week 12* mean (SE) | 149.74 (6.18) | 157.68 (4.04) | |
Week 12* adjusted meanchange from baseline (SE) | -13.73 (4.51) | -4.22 (4.20) | -9.51 (6.16) P = 0.12 |
Patients achieving HbA1c levels | n = 74 | n = 84 | |
HbA1c <7%, n (%) | 29 (37.5) | 19 (24.2) | -- |
HbA1c ≤6.5%, n (%) | 19 (24.6) | 8 (10.7) | -- |