FDA OKs SGLT2 Inhibitor Ertugliflozin for Type 2 Diabetes

Officials with the FDA have approved ertugliflozin (Steglatro, Merck and Pfizer) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes, according to a press release. The sodium/glucose cotransporter 2 (SGLT2) inhibitor is approved in 5-mg and 15-mg tablets to be taken once daily.

Ertugliflozin is also approved as part of 2 fixed-dose combinations. Ertugliflozin and sitagliptin (Steglujan), available as 5-mg ertugliflozin/100-mg sitagliptin and 15-mg ertugliflozin/100-mg sitagliptin, can be taken once daily. Ertugliflozin and metformin (Segluromet), available as 2.5-mg ertugliflozin/500-mg metformin, 2.5-mg/1000-mg, 7.5-mg/500-mg, and 7.5-mg/1000-mg, is to be taken twice daily.

Two phase 3 studies (VERTIS MET and VERTIS SITA) of ertugliflozin met their primary endpoints.¹ In the studies, both doses of ertugliflozin tested (5 mg and 15 mg daily) achieved statistically significant reductions in A1C, a measure of blood glucose over a 2-3 month period, when added to metformin or in initial co-administration with sitagliptin.

In VERTIS MET, patients taking ertugliflozin 5 mg and 15 mg and metformin experienced greater reductions in A1C compared to placebo. As an add on treatment to metformin, treatment with ertugliflozin also resulted in significant reductions in fasting plasma glucose, body weight, systolic blood pressure and diastolic blood pressure, compared with placebo.

In VERTIS SITA, patients taking ertugliflozin 5 mg or 15 mg, in combination with sitagliptin 100 mg, experienced greater reductions in A1C compared with patients taking placebo alone. Treatment with the initial combination of ertugliflozin and sitagliptin also resulted in significant reductions in fasting plasma glucose, body weight, and systolic blood pressure compared with placebo.

Reference

• Merck and Pfizer Announce that Investigational SGLT-2 Inhibitor Ertugliflozin Met Primary Endpoint in Two Phase 3 Studies [news release]. Merck’s website. http://investors.merck.com/news/press-release-details/2017/Merck-and-Pfizer-Announce-that-Investigational-SGLT-2-Inhibitor-Ertugliflozin-Met-Primary-Endpoint-in-Two-Phase-3-Studies/default.aspx. Accessed December 20, 2017.