FDA: New Drug to Control Blood Sugar in Diabetes

The FDA has approved a new tablet, empagliflozin (Jardiance, Boehringer Ingelheim Pharaceuticals, Inc.), to improve glycemic control in adults with type 2 diabetes.

Jardiance is a sodium glucose co-transporter 2 (SGLT2) inhibitor and works by blocking the reabsorption of glucose by the kidney, increasing glucose excretion, and lowering blood sugar in diabetics with elevated levels.
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“It can be used alone or added to existing treatment regimens to control blood sugar levels in the overall management of diabetes,” said Curtis J. Rosenbraugh, MD, MPH, director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research.

In 7 clinical trials with 4480 patients with type 2 diabetes, Jardiance improved hemoglobin A1c levels compared to placebo. The drug has been studied as a stand-alone therapy and as an adjunct treatment in combination with metformin, sulfonylureas, pioglitazone, and insulin.

The most common side effects include urinary tract infections and female genital infections. It has also be linked to dehydration, hypotension, dizziness and/or fainting, and a decline in renal function.

Jardiance should not be used to treat individuals with type 1 diabetes, diabetic ketoacidosis, severe renal impairment including end stage renal disease, or patients on dialysis.

The FDA is requiring 4 postmarketing studies including the completion of an ongoing cardiovascular outcomes trial, a pediatric pharmacokinetic/pharmacodynamics study, a pediatric safety and efficiacy study, and a nonclinical juvenile toxicity study.

-Pooja Shah

Reference:

FDA. FDA approves Jardiance to treat type 2 diabetes [press release]. August 1, 2014. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm407637.htm. Accessed August 4, 2014.