| Parameter/ HbA1c (%) | Statistics | PDM011011 | Metformin | Difference between PDM011011 and Metformin 95%CI (Lower Cl, Upper CI) |
| PP Population | N | 73 | 35 | - |
| Baseline/Visit 1 | Mean (SD) | 8.29 (1.02) | 8.08 (1.01) | - |
| Visit 4 (week 3) | Mean (SD) | 8.11 (1.08) | 7.88 (1.22) |
|
| Change from baseline to Visit 4 | 95% CI (Lower Cl, Upper CI) | 0.05, 0.30 | 0.004, 0.39 | -0.24, 0.21* |
| Visit 7 (week 15) | Mean (SD) | 8.01 (1.25) | 7.46 (1.13) | - |
| Change from baseline to Visit 7 | Mean (SD) | 0.27 (0.89) | 0.62 (0.63) | -0.34 (0.81) |
| 95% CI (Lower Cl, Upper CI) | 0.06, 0.47 | 0.40, 0.83 | -0.64, -0.04** | |
| ITT Population |
|
|
|
|
| Baseline/Visit 1 | N | 80 | 39 | - |
|
| Mean (SD) | 8.32 (1.01) | 8.14 (1.05) | - |
| Visit 4 (week 3) | N | 80 | 39 | - |
|
| Mean (SD) | 8.12 (1.05) | 7.94 (1.25) | - |
| Change from baseline to Visit 4 | N | 80 | 39 | - |
|
| Mean (SD) | 0.20 (0.55) | 0.20 (0.54) | −0.003 (0.55) |
| 95% CI (Lower Cl, Upper CI) | 0.07, 0.32 | 0.02, 0.37 | −0.21, 0.21* | |
| Visit 7 (week 15) | N | 75 | 36 | - |
|
| Mean (SD) | 8.03 (1.24) | 7.51 (1.15) | - |
| Change from baseline to Visit 7 | N | 75 | 36 | - |
|
| Mean (SD) | 0.27 (0.88) | 0.62 (0.62) | −0.34 (0.80) |
| 95% CI (Lower Cl, Upper CI) | 0.06, 0.47 | 0.41, 0.82 | −0.63, −0.05** |