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. 2009 May 28;32(9):1649–1655. doi: 10.2337/dc08-1984

Table 1.

Key glycemic efficacy end points: changes from baseline

Efficacy end point (week 24) PBO + MET 2.5 mg SAXA + MET 5 mg SAXA + MET 10 mg SAXA + MET
n 179 192 191 181
A1C (%)
    n 175 186 186 180
    Adjusted change from baseline 0.13 ± 0.07 −0.59 ± 0.07* −0.69 ± 0.07* −0.58 ± 0.07*
    Difference vs. PBO −0.73 ± 0.10 −0.83 ± 0.10 −0.72 ± 0.10
FPG (mg/dl)
    n 176 188 187 181
    Adjusted change from baseline 1.2 ± 2.56 −14.3 ± 2.48* −22.0 ± 2.49* −20.5 ± 2.53*
    Difference vs. PBO −15.6 ± 3.56 −23.3 ± 3.57 −21.7 ± 3.60
A1C <7.0% (%)
    n 175 186 186 180
    n (%) 29 (16.6) 69 (37.1)* 81 (43.5)* 80 (44.4)*
    Difference vs. PBO 20.5 27.0 27.9
PPG AUC (mg/dl)
    n 131 150 146 148
    Adjusted change from baseline −3,291 ± 853.2 −8,891 ± 798.0* −9,586 ± 810.5* −8,137 ± 807.9*
    Difference vs. PBO −5,599 ± 1,168.2 −6,294 ± 1,176.8 −4,845 ± 1,175.1
PPG at 120 min (mg/dl)
    n 135 155 155 152
    Adjusted change from baseline −18.0 ± 6.02 −61.5 ± 5.62* −58.2 ± 5.62* −49.8 ± 5.70*
    Difference vs. PBO −43.5 ± 8.23 −40.3 ± 8.23 −31.8 ± 8.31
PP glucagon AUC (pg·min/ml)
    n 123 140 138 142
    Adjusted change from baseline −4,315 ± 332.7 −5,511 ± 311.9† −5,704 ± 314.0‡ −5,816 ± 309.6§
PP insulin AUC (μU · min/ml)
    n 118 137 133 136
    Adjusted change from baseline −7 ± 288.0 1,521 ± 267.3* 1,079 ± 271.4‖ 1,635 ± 268.3*
PP C-peptide AUC (ng·min/ml)
    n 123 143 138 137
    Adjusted change from baseline 66 ± 32.9 231 ± 30.5 278 ± 31.1* 249 ± 31.2*
OGIS (ml/min · m2)
    n 117 135 135 136
    Change from baseline 3.2 ± 7.60 27.7 ± 9.15 46.7 ± 8.14 30.4 ± 10.27
Insulinogenic index
    n 109 124 126 121
    Change from baseline 0.04 ± 0.04 0.04 ± 0.09 0.16 ± 0.04 0.20 ± 0.09
HOMA-2β (%)
    n 166 175 180 173
    Adjusted change from baseline 4.9 ± 2.25 16.5 ± 2.19 17.6 ± 2.16 18.1 ± 2.20

Data are means ± SE unless indicated otherwise.

*P ≤ 0.0001 vs. placebo;

†P = 0.0090 vs. placebo;

‡P = 0.0025 vs. placebo;

§P = 0.0010 vs. placebo;

‖P = 0.0063 vs. placebo;

P = 0.0003 vs. placebo. MET, metformin; PBO, placebo; PP, postprandial; SAXA, saxagliptin.