Omarigliptin Achieves Primary Efficacy Endpoint in Phase 3 Study

Blood glucose lancet
Blood glucose lancet
Once-weekly DPP-4 inhibitor achieved its primary efficacy endpoint in a phase 3 study comparing it with once daily Januvia.

Merck announced that its investigational once-weekly DPP-4 inhibitor omarigliptin achieved its primary efficacy endpoint in a phase 3 study in adults with type 2 diabetes.

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, noninferiority trial assessing the efficacy, safety and tolerability of omarigliptin 25 mg once weekly compared with Januvia (sitagliptin) 100 mg once daily in adults with type 2 diabetes (n=642) who experienced inadequate glycemic control on metformin. 

The primary efficacy endpoint was noninferiority of omarigliptin to Januvia in decreasing HbA1c levels from baseline to week 24.

Results from the trial showed that omarigliptin was noninferior to Januvia at reducing patients’ HbA1c levels from baseline, with similar HbA1c reductions achieved in both groups. 

At week 24, patients taking omarigliptin had an average HbA1c reduction from baseline of –0.47%, as compared with an average reduction of –0.43% among patients taking Januvia (difference, –0.03%; 95% CI, –0.15 to 0.08).

In patients in the prespecified subgroup with a higher baseline HbA1c of ≥8%, omarigliptin treatment resulted in a reduction of –0.79% compared with –0.71% for Januvia (difference, –0.08%; 95% CI, –0.37 to 0.21). In addition, the percentage of patients achieving their HbA1c goals was similar for both omarigliptin and Januvia groups. 

At 24 weeks, 51% of patients treated with omarigliptin reached an HbA1c of <7% compared with 49% of patients treated with Januvia (P=.334). The percentage of patients reaching an HbA1c of <6.5% was also similar across treatment groups: 27% for omarigliptin compared with 23% for Januvia (P=.219).

Merck plans to submit for regulatory approval of omarigliptin by the end of 2015.

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This article originally appeared on MPR