Table 3

Efficacy end points at week 78

ParameterPlacebo/metforminOmarigliptin once weekly
0.25/25 mg1/25 mg3/25 mg10/25 mg25 mg
HbA1cn = 80n = 83n = 91n = 79n = 82n = 70
 Baseline
  HbA1c, % 8.2 ± 0.98.1 ± 0.98.0 ± 0.97.9 ± 0.88.0 ± 0.98.0 ± 0.8
  HbA1c, mmol/mol65.7 ± 9.965.4 ± 9.964.1 ± 9.862.4 ± 8.864.4 ± 9.464.2 ± 9.3
 Change from baseline
  HbA1c, % −0.73 (−1.07, −0.40)−0.46 (−0.80, −0.13)−0.28 (−0.61, 0.06)−0.18 (−0.52, 0.17)−0.35 (−0.71, 0.01)−0.34 (−0.70, 0.03)
  HbA1c, mmol/mol−8.0 (−11.7, −4.3)−5.1 (−8.8, −1.4)−3.0 (−6.7, 0.7)−1.9 (−5.7, 1.9)−3.9 (−7.8, 0.1)−3.7 (−7.7, 0.3)
2-h PMG, mmol/Ln = 79n = 83n = 91n = 79n = 82n = 70
 Baseline13.6 ± 3.913.0 ± 3.612.9 ± 3.612.6 ± 3.613.0 ± 4.313.3 ± 4.4
 Change from baseline−2.2 (−3.2, −1.3)−2.1 (−3.0, −1.1)−1.2 (−2.1, −0.2)−1.0 (−2.0, −0.0)−1.5 (−2.6, −0.5)−2.4 (−3.4, −1.4)
FPG, mmol/Ln = 80n = 83n = 91n = 79n = 82n = 70
 Baseline9.6 ± 2.49.5 ± 2.39.5 ± 2.59.2 ± 1.99.2 ± 2.39.6 ± 2.6
 Change from baseline−0.6 (−1.5, 0.2)−0.2 (−1.1, 0.6)−0.2 (−1.0, 0.6)−0.0 (−0.9, 0.9)−0.2 (−1.1, 0.7)0.2 (−0.7, 1.1)
  • Baseline and week 78 data are presented as mean ± SD. Change from baseline is the LS mean change from baseline at week 78 (95% CI). To convert PMG or FPG in mmol/L to mg/dL, multiply by 18.