Table 2.
AWARD-5 Clinical Trial: Dulaglutide versus Sitagliptin as Add-On Therapy to Metformin, at Week 52
| Efficacy parameter | Dulaglutide 0.75 mg (N = 281) |
Dulaglutide 1.5 mg (N = 279) |
Sitagliptin 100 mg (N = 273) |
|---|---|---|---|
| Mean HbA1c level | |||
| Baseline, % | 8.2 | 8.1 | 8.0 |
| Change from baseline (adjusted mean), % | −0.9 | −1.1 | −0.4 |
| Difference from sitagliptin, % | −0.5 (95% CI, −0.7 to −0.3)a | −0.7 (95% CI, −0.9 to −0.5)a | |
| Patients reaching HbA1c <7%, % | 49b | 59b | 33b |
| Mean fasting plasma glucose | |||
| Baseline, mg/dL | 174 | 173 | 171 |
| Change from baseline (adjusted mean), mg/dL | −30 | −41 | −14 |
| Difference from sitagliptin, mg/dL | −15 (95% CI, −22 to −9) | −27 (95% CI, −33 to −20) | |
| Mean body weight | |||
| Baseline, kg | 85.5 | 86.5 | 85.8 |
| Change from baseline (adjusted mean), kg | −2.7 | −3.1 | −1.5 |
| Difference from sitagliptin, kg | −1.2 (95% CI, −1.8 to −0.6) | −1.5 (95% CI, −2.1 to −0.9) | |
a
Multiplicity adjusted 1-sided P <.001.
b
P <.002 dulaglutide compared with sitagliptin. CI indicates confidence interval; HbA1c, glycated hemoglobin.
Source: Trulicity (dulaglutide) injection prescribing information; September 2014.