A new SGLT2 inhibitor drug has been approved to treat type 2 diabetes by the US Food and Drug Administration (FDA).
Ertugliflozin was approved both as a single therapy and in combination with metformin and Januvia (sitagliptin) following successful results from two phase III trials earlier this year.
The drug has been developed by drug companies Merck and Pfizer, and is currently under review for approval in Europe by the European Medicines Agency.
In the VERTIS MET and VERTIS SITA trials, ertugliflozin was shown to improve blood sugar control and meet its primary outcomes.
VERTIS MET was a 26-week study which evaluated the effectiveness and safety of 5mg and 15mg ertugliflozin in combination with metformin, compared to placebo and metformin, among 464 adults with poorly controlled type 2 diabetes taking just metformin.
Those taking the ertugliflozin combination had lower HbA1c levels, lower blood glucose levels, lost more weight and had lower blood pressure.
In the VERTIS SITA trial, the same doses of ertugliflozin were tested in combination with Januvia, compared to placebo and Januvia, with similar results observed.
The safety profile of ertugliflozin, which will now be available in the US under the brand names Steglujan and Segluromet, was consistent with other SGLT2 drugs.
“As the global burden of diabetes continues to rise, we are committed to meeting patients’ needs with additional treatment options to help manage their condition,” said James Rusnak, MD, PhD, chief development officer for cardiovascular and metabolic diseases, Pfizer Global Product Development, who added the study findings “underscore the potential of ertugliflozin as an important therapeutic option” for adults with type 2 diabetes.
The therapies are expected to be made available in the US in early 2018.
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