Table 2.
Changes in primary and secondary endpoints from baseline to EOS in the EAS and FASa
| EAS | FAS | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| nb | Baseline mean (SD) | Mean at EOSc | Change from baseline (95% CI) | p-value | nb | Baseline mean (SD) | Mean at EOSc | Change from baseline (95% CI) | p-value | |
| HbA1c (mmol/mol) | 149 | 72.1 (16.8) | 55.8 |
− 16.3 (− 18.22, − 14.37) |
< 0.0001 | 183 | 72.9 (17.6) | 56.8 |
− 16.6 (− 18.41, − 14.75) |
< 0.0001 |
| HbA1c (%-point) | 149 | 8.7 ( 1.5) | 7.3 |
− 1.5 (− 1.67, − 1.31) |
< 0.0001 | 183 | 8.8 (1.6) | 7.4 |
− 1.5 (− 1.68, − 1.35) |
< 0.0001 |
| Body weight (kg) | 149 | 108.4 (24.6) | 102.6 |
− 5.8 (− 6.75, − 4.94) |
< 0.0001 | 161 | 108.6 (25.9) | 103.0 |
− 5.6 (− 6.48, 4.71) |
< 0.0001 |
| Waist circumference(cm) | 118 | 118.6 (17.3) | 112.8 |
− 5.8 (− 7.05, − 4.55) |
< 0.0001 | 128 | 119.0 (17.4) | 113.2 |
− 5.9 (− 7.07, − 4.64) |
< 0.0001 |
Data shown are in-study values
CI confidence interval, EAS effectiveness analysis set, EOS end of study, FAS full analysis set, HbA1c glycated haemoglobin, SD standard deviation
aChanges in HbA1c in the FAS were determined using a mixed model for repeated measurements
bNumbers of patients refer to those included in the analysis
cMean values for EOS are estimated means