Ertugliflozin Evaluated as Add-On to Metformin, Sitagliptin
This article is part of MPR's coverage of the American Diabetes Association's 77th Scientific Sessions (ADA 2017), taking place in San Diego, CA. Our staff will report on medical research and technological advances in diabetes and diabetes education, conducted by experts in the field. Check back regularly for more news from ADA 2017.
Merck and Pfizer announced at the American Diabetes Association 77th Scientific Sessions, San Diego, CA, that two Phase 3 studies evaluating ertugliflozin in adults with type 2 diabetes met their primary endpoints
VERTIS MET was a randomized, double-blind, 26-week study that evaluated ertugliflozin in combination with metformin vs. placebo and metformin in 621 adults with type 2 diabetes who were uncontrolled on metformin alone. There were greater reductions in HbA1c among patients taking ertugliflozin 5mg or 15mg with metformin vs. placebo at 26 weeks (0.7% and 0.9% vs. 0.0%; P<0.001). Also, patients taking ertugliflozin 5mg or 15mg with metformin achieved the A1c goal <7.0% vs. patients taking placebo and metformin. Adding ertugliflozin to metformin therapy further led to significant reductions in fasting plasma glucose, body weight, systolic/diastolic blood pressure vs. placebo.
VERTIS SITA was a randomized, double-blind, multicenter, 26-week study that evaluated ertugliflozin in combination with sitagliptin (Januvia) vs. placebo in 291 patients with type 2 diabetes inadequately controlled with diet and exercise. There were greater reductions in HbA1c among patients taking ertugliflozin 5mg or 15mg with sitagliptin 100mg vs. placebo at 26 weeks (1.6% and 1.7% vs. 0.4%; P<0.001). Significantly more patients taking ertugliflozin and sitagliptin achieved the A1c goal <7.0% when compared to placebo. Initial treatment with ertugliflozin and sitagliptin further led to significant reductions in fasting plasma glucose, body weight, and systolic blood pressure vs. placebo.
VERTIS CV is currently ongoing to evaluate to cardiovascular outcomes with ertugliflozin. The study, involving approximately 8,000 patients, is aiming to assess the non-inferiority of ertugliflozin to placebo for the composite outcome of cardiovascular death, nonfatal myocardial infarction or nonfatal stroke (MACE).
Ertugliflozin is an investigational oral sodium-glucose co-transporter 2 (SGLT-2) inhibitor. Sitagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor currently indicated as monotherapy or combination therapy in addition to diet and exercise for the treatment of type 2 diabetes. Metformin is a biguanide indicated as monotherapy or with a sulfonylurea or insulin in addition to diet and exercise for the treatment of type 2 diabetes.
The Prescription Drug User Fee Act (PDUFA) action date from the Food and Drug Administration (FDA) for ertugliflozin, ertugliflozin + metformin, and ertugliflozin + sitagliptin are set for December 2017.
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