Table 2 Changes in glycemic parameters from baseline to week 24 (LOCF)
SAXA 2.5 mg q.A.M. (n = 74) | SAXA 5 mg q.A.M. (n = 74) | SAXA 2.5/5 mg q.A.M. (n = 71) | SAXA 5 mg q.P.M. (n = 72) | Placebo (n = 74) | |
|---|---|---|---|---|---|
HbA 1c (%) | |||||
n | 67 | 69 | 69 | 70 | 68 |
BL, mean (SE) | 8.0 (0.11) | 7.9 (0.11) | 8.0 (0.13) | 7.9 (0.11) | 7.8 (0.11) |
Week 24 mean (SE) | 7.3 (0.11) | 7.3 (0.13) | 7.4 (0.14) | 7.3 (0.12) | 7.6 (0.14) |
Adj change from BL, mean (SE) | −0.71 (0.103) | −0.66 (0.102) | −0.63 (0.102) | −0.61 (0.101) | −0.26 (0.103) |
Difference from placebo (SE) | −0.45 (0.146) | −0.40 (0.145) | −0.37 (0.145) | −0.35 (0.144) | |
P-value vs placebo | 0.002* | 0.006* | 0.012* | 0.016* | |
FPG (mg/dL) | |||||
n | 70 | 71 | 71 | 71 | 71 |
BL, mean (SE) | 157 (4.0) | 162 (4.2) | 171 (6.2) | 160 (5.3) | 159 (5.4) |
Week 24 mean (SE) | 147 (3.8) | 151 (5.9) | 155 (5.9) | 152 (5.9) | 163 (6.3) |
Adj change from BL, mean (SE) | −11 (4.5) | −11 (4.5) | −13 (4.5) | −8 (4.5) | 3 (4.5) |
Difference from placebo (SE) | −15 (6.3) | −14 (6.3) | −16 (6.3) | −11 (6.3) | |
P-value vs placebo | 0.020* | 0.027* | 0.013* | 0.076 | |
Patients achieving HbA 1c <7% (%) | 35.8 | 44.9 | 43.5 | 38.6 | 35.3 |
Difference from placebo (%) | 0.5 | 9.6 | 8.2 | 3.3 | |
P-value vs placebo | 1.0000 | 0.2968 | 0.3832 | † | |
PPG–AUC (mg·min/dL) | |||||
n | 48 | 48 | 47 | 43 | 47 |
BL, mean (SE) | 47432 (1496.6) | 50417 (1561.5) | 50032 (1684.7) | 47078 (1941.9) | 47640 (1759.7) |
Week 24 mean (SE) | 39798 (1347.0) | 41562 (1489.3) | 41745 (1739.2) | 41530 (1962.7) | 44861 (1854.7) |
Adj change from BL, mean (SE) | −8014 (1246.9) | −8218 (1249.1) | −7781 (1261.0) | −6048 (1318.2) | −3088 (1259.7) |
Difference from placebo (SE) | −4927 (1771.1) | −5130 (1776.4) | −4694 (1784.3) | −2961 (1821.5) | |
P-value vs placebo | † | † | † | † |