New SGLT2 drug shown to have benefits as part of triple therapy

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An investigational drug called ertugliflozin helps to lower HbA1c levels in people with type 2 diabetes in combination with metformin and Januvia (sitagliptin), research shows.
Ertugliflozin is an SGLT2 inhibitor developed by Merck and Co which has previously been reported to have benefits for blood sugar, weight loss and blood pressure.
In this new trial, called the VERTIS SITA2 study, ertugliflozin was shown to boost blood sugar control as part of triple therapy, which some people are prescribed if they cannot sufficiently control their diabetes.
“Few clinical trials have rigorously tested the efficacy of triple oral agents on diabetes. The introduction of SGLT2 inhibitors provided opportunity for conducting such a study,” said Sam Dagogo-Jack, MD, University of Tennessee Health Science Center in Memphis.
The 26-week trial studied 464 people with poorly controlled type 2 diabetes who took metformin plus Januvia and were then randomised to take either 5mg or 15mg per day of ertugliflozin, or placebo.
The findings showed 32.1 and 39.9 per cent of the 5mg and 15mg ertugliflozin groups, respectively, improved their HbA1c to less than 53 mmol/mol (7%), compared to only 17 per cent of those on placebo.
Those in the ertugliflozin groups also lost more weight and had improvements in blood pressure. These improvements were sustained during a period of an additional 26 weeks, the second phase of the trial.
The safety profile of the drug was largely similar to other SGLT2 drugs. No cases of ketoacidosis were reported and there was only one case of severe hypoglycemia, which was reported in the placebo group.
Researchers are planning further additional studies, including FDA required cardiovascular safety trials, Dagogo-Jack said, as they seek US approval for the drug.
The findings were presented at the European Association for the Study of Diabetes (EASD) 2017 Annual Meeting and also appear online in the journal Diabetes, Obesity and Metabolism.