The clinical development program for omarigliptin, O-QWEST (Omarigliptin Q Weekly Efficacy and Safety in Type 2 Diabetes), includes 10 Phase 3 clinical trials involving approximately 8,000 patients with type 2 diabetes. This Phase 3 study is a randomized, double-blind, non-inferiority trial assessing the efficacy, safety and tolerability of omarigliptin 25mg once weekly compared to Januvia (sitagliptin) 100mg once daily in adults with type 2 diabetes (n=642) who experienced inadequate glycemic control on metformin. The primary efficacy endpoint was non-inferiority of omarigliptin to Januvia in decreasing A1C levels from baseline to week 24.
Results from the trial showed that omarigliptin was non-inferior to Januvia at reducing patients’ A1C levels from baseline, with similar A1C reductions achieved in both groups. At week 24, patients taking omarigliptin had an average A1C reduction from baseline of -0.47% as compared to an average reduction of -0.43% among patients taking Januvia (difference = -0.03%; 95% CI [-0.15, 0.08]). In patients in the pre-specified sub-group with a higher baseline A1C of ≥8%, omarigliptin treatment resulted in reductions of -0.79% compared to -0.71% for Januvia (difference = -0.08%; 95% CI [-0.37, 0.21]). In addition, the percentage of patients achieving their A1C goals was similar for both omarigliptin and Januvia. At 24 weeks, 51% of patients treated with omarigliptin reached an A1C of <7%, compared to 49% of patients treated with Januvia (P=0.334). The percentage of patients reaching an A1C of <6.5% was also similar across treatment groups: 27% for omarigliptin compared with 23% for Januvia (P=0.219).
Merck plans to submit for regulatory approval of omarigliptin by the end of 2015.
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