Table 2.
Efficacy endpoints—HbA1c percent change from baseline (FAS)
| Alogliptin 25 mg QD (n = 75) | Placebo (n = 76) | p value | |
|---|---|---|---|
| Baseline | |||
| Mean (SD) | 8.2 (1.5) | 8.1 (1.3) | |
| Week 12 | |||
| n | 62 | 62 | |
| Mean (SD) | 7.9 (2.13) | 8.1 (2.0) | |
| Change from baselinea | − 0.36 (0.22) | − 0.32 (0.22) | |
| Between-group differenceb | − 0.05 (0.26; − 0.57, 0.48) | 0.86 | |
| Week 18 | |||
| n | 54 | 61 | |
| Mean (SD) | 8.1 (2.4) | 8.1 (2.2) | |
| Change from baselinea | − 0.20 (0.25) | − 0.21 (0.25) | |
| Between-group differenceb | 0.004 (0.31; − 0.61, 0.62) | 0.99 | |
| Week 26 | |||
| n | 54 | 56 | |
| Mean (SD) | 7.9 (2.1) | 8.2 (2.4) | |
| Change from baselinea | 0.09 (0.28) | − 0.01 (0.28) | |
| Between-group differenceb | 0.10 (0.37; − 0.63, 0.83) | 0.78 | |
| Week 39 | |||
| n | 49 | 47 | |
| Mean (SD) | 7.7 (2.1) | 8.4 (1.8) | |
| Change from baselinea | 0.09 (0.29) | 0.50 (0.28) | |
| Between-group differenceb | − 0.41 (0.37; − 1.14, 0.32) | 0.26 | |
| Week 52 | |||
| n | 39 | 39 | |
| Mean (SD) | 7.6 (2.0) | 8.3 (2.2) | |
| Change from baselinea | 0.28 (0.32) | 0.76 (0.31) | |
| Between-group differenceb | − 0.48 (0.42; − 1.31, 0.34) | 0.25 | |
All values are presented as mean (SD)
CI confidence interval, FAS full analysis set, HbA1c glycosylated hemoglobin, LS least squares, QD once daily, SD standard deviation, SE standard error
aLS mean SE
bDifference between alogliptin (25 mg QD) vs placebo in LS indicates SE (95% CI)