Table 4.
Change in FPG and 2-h PPG from baseline in the pharmacodynamic analysis set
| Placebo (n=15) | 50+50 mg PB-201 (n=16) | 100+50 mg PB-201 (n=15) | 100+100 mg PB-201 (n=15) | |
|---|---|---|---|---|
| FPG, mmol/L | ||||
| Baseline, mean (SD) | 9·047 (1·157) | 9·656 (1·283) | 9·207 (1·545) | 9·087 (1·442) |
| Day 7, mean (SD) | 9·353 (1·627) | 8·919 (2·350) | 7·980 (1·032) | 7·613 (1·250) |
| Change from baseline, mean (SD) | 0·306 (1·029) | −0·737 (2·336) | −1·227 (1·833) | −1·473 (0·928) |
| LSM change from baseline (90% CI) | 0·306 (−0·463 to 1·076) | −0·738 (−1·714 to 0·239) | −1·227 (−2·033 to −0·421) | −1·473 (−2·307 to −0·640) |
| Placebo-adjusted difference in LSM change from baseline (90% CI) | NA | −1·044 (−2·038 to −0·051) | −1·533 (−2·543 to −0·254) | −1·780 (−2·789 to 0·771) |
| P value* | NA | 0·084 | 0·014 | 0·005 |
| 2-h PPG, mmol/L | ||||
| Baseline, mean (SD) | 15·773 (2·776) | 16·550 (2·073) | 15·727 (2·519) | 15·780 (2·747) |
| Day 7, mean (SD) | 16·600 (2·450) | 15·681 (4·233) | 14·140 (2·795) | 13·900 (3·155) |
| Change from baseline, mean (SD) | 0·827 (1·390) | −0·869 (3·635) | −1·587 (1·209) | −1·880 (3·131) |
| LSM change from baseline (90% CI) | 0·827 (−0·800 to 2·453) | −0·869 (−2·869 to 1·131) | −1·587 (−3·239 to 0·066) | −1·880 (−3·717 to −0·043) |
| Placebo-adjusted difference in LSM change from baseline (90% CI) | NA | −1·696 (−3·250 to −0·138) | −2·413 (−3·996 to −0·831) | −2·707 (−4·289 to −1·124) |
| P value* | NA | 0·007 | 0·014 | 0·006 |
FPG=fasting plasma glucose. LSM=least-square mean. NA=not applicable. SD=standard deviation. 2-h PPG=2-h postprandial plasma glucose. 90% CI= 90% confidence interval.
⁎
Compared with placebo.