Merck in partnership with Pfizer Inc. announced that two Phase 3 studies (VERTIS Mono and VERTIS Factorial) of ertugliflozin, an investigational oral SGLT-2 inhibitor for the treatment of patients with type 2 diabetes, met their primary endpoints.
The study results showed statistically significant reductions in A1C (a measure of average blood glucose) for both ertugliflozin doses tested (5 mg and 15 mg daily). These results from the VERTIS clinical development program of ertugliflozin will be presented for the first time at the 76th Scientific Sessions of the American Diabetes Association, which are being held in New Orleans from June 10-14, 2016.
A 26-week investigational study (VERTIS Mono), which evaluated ertugliflozin as monotherapy, met its primary endpoint, showing that patients randomized to ertugliflozin 5 mg and 15 mg had significantly greater A1C reductions of 0.99 percent and 1.16 percent, respectively, compared with placebo (p<0.001, for both comparisons). In addition, significantly more patients taking ertugliflozin 5 mg and 15 mg achieved the A1C treatment goal of less than 7.0 percent (28.2 percent and 35.8 percent, respectively) compared with placebo (13.1 percent) (p<0.001, for both comparisons), which was a secondary endpoint of the study.
VERTIS Factorial, another 26-week investigational study, evaluated the co-administration of ertugliflozin and Merck’s DPP-4 inhibitor JANUVIA® (sitagliptin). This study also met its primary endpoint, with greater reductions in A1C observed in patients taking ertugliflozin in combination with sitagliptin compared to ertugliflozin or sitagliptin alone. An A1C reduction of 1.5 percent was observed in both combinations studied (ertugliflozin 5 mg or 15 mg with sitagliptin 100 mg), as compared with A1C reductions of 1.0 percent with ertugliflozin 5 mg alone, 1.1 percent with ertugliflozin 15 mg alone, and 1.1 percent with sitagliptin 100 mg alone (p<0.001 for both combinations vs. individual treatments).
In addition, the co-administration of ertugliflozin and sitagliptin was significantly more effective than ertugliflozin or sitagliptin alone in achieving the A1C treatment goal of less than 7.0 percent, which was a secondary endpoint of the study. Specifically, 52.3 percent of patients taking ertugliflozin 5 mg in combination with sitagliptin 100 mg and 49.2 percent of patients taking ertugliflozin 15 mg in combination with sitagliptin 100 mg reached an A1C goal of less than 7.0 percent. In comparison, 26.4 percent achieved this A1C goal with ertugliflozin 5 mg, 31.9 percent with ertugliflozin 15 mg, and 32.8 percent with sitagliptin 100 mg (p<0.001 for both combinations vs. individual treatments in model-based tests).
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Please see Prescribing Information for JANUVIA ® (sitagliptin) at http://www.merck.com/product/usa/pi_circulars/j/januvia/januvia_pi.pdf and Medication Guide for JANUVIA at http://www.merck.com/product/usa/pi_circulars/j/januvia/januvia_mg.pdf .
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