Table 3.
Efficacy endpoints
| Parameter | Sitagliptin, N = 329 | Placebo, N = 329 |
|---|---|---|
| Daily insulin dose, IU | ||
| Baseline | 37.3 ± 20.8 | 36.6 ± 21.3 |
| Week 24 | 54.8 ± 29.3 | 59.9 ± 31.9 |
| Change from baseline* | 19.0 (16.5, 21.6) | 23.8 (21.3, 26.3) |
| Difference from placebo | −4.7† (−8.3, −1.2) | – |
| HbA1c, % (mmol/mol) | ||
| Baseline | 8.7 ± 1.0 (71.2 ± 10.8) | 8.8 ± 1.0 (72.8 ± 11.3) |
| Week 24 | 7.3 ± 1.1 (56.7 ± 11.8) | 7.9 ± 1.2 (62.9 ± 13.3) |
| Change from baseline* | −1.3 (−1.4, −1.2) (−14.3 [−15.6, −13.1]) | −0.9 (−1.0, −0.8) (−9.5 [−10.7, −8.2]) |
| Difference from placebo | −0.4‡ (−0.6, −0.3) (−4.9 [−6.6, −3.2]) | – |
| Fasting plasma glucose, mmol/L | ||
| Baseline | 9.8 ± 2.6 | 9.8 ± 2.5 |
| Week 24 | 6.7 ± 2.0 | 7.3 ± 2.4 |
| Change from baseline | −3.1 (−3.4, −2.8) | −2.5 (−2.8, −2.2) |
| Difference from placebo | −0.6‡ (−1.0, −0.2) | – |
Values are mean ± standard deviation unless noted
To convert fasting plasma glucose in mmol/L to mg/dL, multiply by 18
HbA1c glycated hemoglobin
* Least squares (LS) mean (95% confidence interval (CI)); † p = 0.009 vs placebo; ‡ p ≤ 0.001 vs placebo