A post-hoc pooled analysis of two placebo controlled phase 3 trials, Assessment of Weekly AdministRation of LY2189265 in Diabetes -1 and -5 (AWARD-1 and AWARD-5): dulaglutide compared with exenatide, sitagliptin, and placebo

Aim: To compare once weekly dulaglutide 1.5 mg and dulaglutide 0.75 mg with placebo at 26 weeks, and with sitagliptin 100 mg once daily (AWARD-5) and exenatide 10 µg twice daily (AWARD-1) at 26 and 52 weeks in patients with Type 2 diabetes with a mean baseline HbA1c of approximately 8%.

Methods: Data from the dulaglutide 1.5 mg, dulaglutide 0.75 mg or placebo arms were pooled by treatment. Comparisons were made for change (LS mean [SE]) in HbA1c and percentage of patients achieving HbA1c targets of < 7% and ≤6.5% at 26 weeks and 52 weeks.

Results: At 26 weeks, dulaglutide 1.5 mg and dulaglutide 0.75 mg showed reductions in HbA1c of -1.34 (0.05)% and -1.12 (0.05)%, respectively, that were significantly greater than those for exenatide (-0.80 [0.06]%), sitagliptin (-0.74 [0.06]%) and placebo (-0.15 [0.06]%) (p < 0.001, all comparisons). More patients achieved an HbA1c < 7% with dulaglutide (1.5 mg: 69%; 0.75 mg: 60%) compared with exenatide (52%), sitagliptin (38%) and placebo (30%) (p < 0.001, all comparisons). Similar results were demonstrated for both dulaglutide doses at the ≤6.5% target compared with exenatide, sitagliptin and placebo (p < 0.001, all comparisons). At 52 weeks, both dulaglutide 1.5 mg and 0.75 mg showed a greater HbA1c change from baseline compared with exenatide and sitagliptin, with more patients achieving an HbA1c < 7% and ≤6.5% (p < 0.001, all comparisons).

Conclusion: Compared with other commonly used incretin-based therapies, once weekly dulaglutide showed superior efficacy demonstrable up to 52 weeks. These robust reductions in HbA1c were observed despite a relatively low mean baseline HbA1c.

Presenter: Heike Jung