Table 4.
Efficacy endpoints at weeks 24 and 52
| Parameter week 24 | SU + omarigliptin n = 126 |
SU + placebo n = 63 |
GL + omarigliptin n = 65 |
GL + placebo n = 34 |
BG + omarigliptin n = 66 |
BG + placebo n = 33 |
TZD + omarigliptin n = 65 |
TZD + placebo n = 34 |
AGI + omarigliptin n = 67 |
AGI + placebo n = 32 |
|---|---|---|---|---|---|---|---|---|---|---|
| HbA1c, % | ||||||||||
| Baseline | 8.1 ± 0.7 | 8.1 ± 0.6 | 8.0 ± 0.6 | 8.0 ± 0.8 | 7.8 ± 0.6 | 8.0 ± 0.6 | 8.2 ± 0.8 | 7.9 ± 0.8 | 7.9 ± 0.6 | 7.9 ± 0.8 |
| Change from baselinea | −0.84 (−0.94, −0.73) | 0.09 (−0.06, 0.24) | −0.68 (−0.89, −0.48) | 0.30 (−0.04, 0.64) | −0.94 (−1.10, −0.78) | −0.02 (−0.35, 0.31) | −0.88 (−1.04, −0.73) | 0.28 (0.03, 0.53) | −0.74 (−0.89, −0.59) | 0.06 (−0.16, 0.28) |
| Change vs. placebob | −0.93c (−1.10, −0.75) | – | −0.98c (−1.37, −0.60) | – | −0.92c (−1.29, −0.56) | – | −1.16c (−1.45, −0.88) | – | −0.80c (−1.06, −0.54) | – |
| FPG, mg/dL | ||||||||||
| Baseline | 165.4 ± 32.0 | 170.5 ± 34.0 | 163.5 ± 29.4 | 164.4 ± 34.7 | 155.8 ± 26.1 | 157.6 ± 20.6 | 163.4 ± 33.6 | 152.4 ± 24.5 | 157.7 ± 24.3 | 159.8 ± 30.7 |
| Change from baselinea | −24.4 (−28.9, −19.9) | −6.8 (−12.7, −0.9) | −19.3 (−27.9, −10.7) | 2.0 (−11.9, 16.0) | −29.0 (−36.0, −22.0) | −14.4 (−27.4, −1.4) | −28.4 (−35.0, −21.8) | −4.5 (−14.4, 5.3) | −20.4 (−26.8, −14.0) | −8.3 (−17.0, 0.4) |
| Change vs. placebob | −17.6c (−24.3, −10.8) | – | −21.3d (−36.5, −6.1) | – | −14.6d (−28.4, −0.8) | – | −23.9c (−34.7, −13.0) | – | −12.1d (−21.9, −2.3) | – |
| Parameter week 52 | SU + omarigliptin/omarigliptin | SU + placebo/omarigliptin | GL + omarigliptin/omarigliptin | GL + placebo/omarigliptin | BG + omarigliptin/omarigliptin | BG + placebo/omarigliptin | TZD + omarigliptin/omarigliptin | TZD + placebo/omarigliptin | AGI + omarigliptin/omarigliptin | AGI + placebo/omarigliptin |
|---|---|---|---|---|---|---|---|---|---|---|
| HbA1c, % | ||||||||||
| Change from baselinea | −0.45 (−0.58, −0.32) | −0.63 (−0.82, −0.45) | −0.59 (−0.84, −0.34) | −0.43 (−0.88, 0.02) | −0.63 (−0.82, −0.45) | −0.62 (−0.99, −0.24) | −0.63 (−0.82, −0.44) | −0.65 (−0.93, −0.36) | −0.60 (−0.77, −0.43) | −0.79 (−1.03, −0.55) |
| FPG, mg/dL | ||||||||||
| Change from baselinea | −8.3 (−14.1, −2.4) | −19.7 (−27.5, −11.9) | −14.7 (−24.1, −5.4) | −4.8 (−21.1, 11.6) | −16.6 (−23.6, −9.7) | −23.4 (−36.7, −10.1) | −17.2 (−23.6, −10.8) | −9.7 (−19.7, 0.4) | −9.3 (−15.1, −3.4) | −22.3 (−30.5, −14.0) |
aLeast-squares (LS) mean [95% confidence interval (CI)] based on longitudinal data analysis models described in the “Statistical Analyses” section
bDifference in LS means (95% CI)
c p < 0.001
d p < 0.05
SU sulfonylurea, GL glinide, BG biguanide, TZD thiazolidinedione, AGI α-glucosidase inhibitor