Table 2

Efficacy end points at week 12

ParameterPlaceboOmarigliptin once weekly
0.25 mg1 mg3 mg10 mg25 mg
HbA1cn = 113n = 113n = 115n = 114n = 115n = 114
 Change from baseline
  HbA1c, % 0.14 (−0.01, 0.30)−0.14 (−0.30, 0.01)−0.36 (−0.51, −0.20)−0.35 (−0.50, −0.19)−0.53 (−0.68, −0.37)−0.57 (−0.73, −0.42)
  HbA1c, mmol/mol1.5 (−0.1, 3.2)−1.5 (−3.2, 0.2)−3.9 (−5.6, −2.2)−3.8 (−5.5, −2.1)−5.8 (−7.4, −4.1)−6.3 (−8.0, −4.6)
 Change vs. placebo
  HbA1c, % −0.28 (−0.50, −0.06)§−0.50 (−0.71, −0.28)*−0.49 (−0.70, −0.27)*−0.67 (−0.88, −0.45)*−0.72 (−0.93, −0.50)*
  HbA1c, mmol/mol−3.1 (−5.5, −0.7)−5.4 (−7.8, −3.1)−5.3 (−7.7, 2.9)−7.3 (−9.7, −4.9)−7.8 (−10.2, −5.4)
2-h PMG, mmol/Ln = 111n = 112n = 113n = 114n = 114n = 112
 Change from baseline0.4 (−0.1, 1.0)−0.6 (−1.2, −0.1)−1.4 (−2.0, −0.9)−1.5 (−2.1, −1.0)−1.9 (−2.4, −1.4)−2.1 (−2.6, −1.5)
 Change vs. placebo−1.0 (−1.8, −0.3)−1.8 (−2.6, −1.1)*−1.9 (−2.7, −1.2)*−2.3 (−3.1, −1.5)*−2.5 (−3.3, −1.7)*
FPG, mmol/Ln = 113n = 113n = 115n = 114n = 115n = 114
 Change from baseline0.3 (−0.0, 0.6)0.1 (−0.2, 0.4)−0.8 (−1.1, −0.5)−0.6 (−0.9, −0.3)−0.5 (−0.9, −0.2)−1.0 (−1.3, −0.7)
 Change vs. placebo−0.2 (−0.7, 0.2)−1.1 (−1.6, −0.7)*−0.9 (−1.3, −0.5)*−0.9 (−1.3, −0.4)*−1.3 (−1.8, −0.9)*
  • Change from baseline is the LS mean change from baseline at week 12 (95% CI). Change vs. placebo is the between-treatment difference in the LS mean change from baseline at week 12 (95% CI). To convert PMG or FPG in mmol/L to mg/dL, multiply by 18.

  • §P = 0.012 from trend test for omarigliptin vs. placebo.

  • *P < 0.001 from trend test for omarigliptin vs. placebo.

  • P = 0.009 from trend test for omarigliptin vs. placebo.

  • P = 0.276 from trend test for omarigliptin vs. placebo.