- Two Phase 3 clinical trials, VERTIS Mono and VERTIS Factorial, evaluating ertugliflozin for the treatment of type 2 diabetes met their primary endpoints showing statistically significant reductions in blood glucose (A1C). The results were presented at the 76th Scientific Sessions of the American Diabetes Association in New Orleans, LA.
- Patients treated with either of two doses (5 mg or 15mg) of ertugliflozin as monotherapy in VERTIS Mono experienced reductions in A1C of 0.99% and 1.16%, respectively, greater than placebo (p<0.001). In addition, many more patients in the treatment group achieved the A1C treatment goal of A1C less than 7.0% than placebo (28.2%, 35.8% and 13.1%, respectively; p<0.001).
- VERTIS Factorial, assessing the co-administration of ertugliflozin and JANUVIA (sitagliptin), showed that the two drugs taken together were more effective than either alone. The A1C reduction in the co-administration group (either 5 mg or 15 mg of ertugliflozin with 100 mg of sitagliptin) was 1.5% compared to 1.0% for 5 mg of ertugliflozin alone, 1.1% for 15 mg of ertugliflozin alone and 1.1% for sitagliptin alone (p<0.001). The percentage of patients taking the two tablets together who achieved the goal of A1C less than 7.0% was also greater (52.3% and 49.2%) versus the single therapy cohorts (26.4%, 31.9% and 32.8%, respectively).
- Ertugliflozin inhibits sodium-glucose co-transporter 2 (SGLT2), a protein that facilitates glucose reabsorption in the kidney. Inhibiting SGLT2 increases the excretion of glucose which lowers blood glucose levels.
- Merck (NYSE:MRK) and Pfizer (PFE) are co-developing and co-commercializing ertugliflozin under their April 2013 global collaboration agreement. They plan to submit New Drug Applications to the FDA for ertugliflozin alone and two fixed-dose combination tablets (ertugliflozin+sitagliptin; ertugliflozin+metformin) by the end of this year.
- Another Phase 3 study, VERTIS CV, assessing ertugliflozin's effect on improving CV outcomes in type 2 diabetics is ongoing. According to ClinicalTrials.gov, the estimated study completion date is June 2020.