Two treatments for adult patients with Type 2 diabetes to be used in conjunction with dietary and exercise regimen improvements recently attained Food and Drug Administration (FDA) approval.
Merck and Pfizer announced the approval of SGLT2 inhibitor Steglatro (ertugliflozin) and fixed-dose combination Steglujan (ertugliflozin and sitagliptin), which followed several large-scale Phase 3 studies. Results showed weight loss with Steglatro treatment when administered concurrently with metformin and sitagliptin.
“In clinical trials, treatment with STEGLATRO resulted in significant A1C reductions when used alone or in combination with sitagliptin,” Dr. Juan Pablo Frias, president and principal investigator at the National Research Institute in Los Angeles, said in a Merck press release. “This is important, as A1C-lowering is a key component of diabetes management, and many of my adult patients may need multiple medications to help manage their condition.”
Dr. James Rusnak, Pfizer’s global product development senior vice president who is also chief development officer for internal medicine, said in the release the company "is pleased to offer additional treatment options to these patients and the healthcare providers who treat them.”
Dr. Keith Kaufman, Merck’s global clinical development and therapeutic area head for diabetes, endocrinology and women’s health, also expressed satisfaction.
“Merck welcomes the opportunity to provide adult patients with type 2 diabetes and their physicians these new medicines to help lower A1C, building on over a decade of experience with our diabetes portfolio and reflecting our continued commitment to diabetes research and patient care,” Kaufman said in the release.
Additionally, the FDA granted approval to Segluromet, a combination of ertugliflozin and metformin hydrochloride, as an alternative for improved glycemic control in cases where ertugliflozin or metformin has not proven effective.
The treatments are contraindicated for patients with serious renal impairment, disease and/or dialysis, as well as those with histories of hypersensitivity to those drugs, the release said.