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ADA: Diabetes Duo Merck & Pfizer Report Positive PhIII Data For Investigational SGLT-2

 
• By Lucie Ellis-Taitt

Merck & Co. Inc. and Pfizer Inc.'s investigational oral SGLT-2 inhibitor, ertugliflozin, has met its primary endpoints in two Phase III studies in type 2 diabetes patients – now the pair are continuing development with an 8,000 patient cardiovascular (CV) outcomes trial and plan to file the drug in US by the year end.

Data from the VERTIS Mono trial – presented at the 2016 American Diabetes Association conference, held in New Orleans 10-14 June – showed that ertugliflozin as a monotherapy treatment improved glucose control in type 2 diabetics. Patients randomized to ertugliflozin 5mg and 15mg had significantly greater A1C reductions at 26 weeks of 0.99% and 1.16%, respectively, compared with placebo (p<0.001, for both comparisons) – the primary endpoint of the study.

In addition, significantly more patients taking ertugliflozin 5mg and 15mg achieved the A1C treatment goal of less than 7.0% (28.2% and 35.8%, respectively) compared with placebo (13.1%; p<0.001, for both...

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