On October 30, the US Food and Drug Administration (FDA) approved the combination oral diabetes drug Xigduo XR for use, along with a healthful diet and exercise, in adults with Type 2 diabetes. The medicine, a development of AstraZeneca, combines dapagliflozin (brand name Farxiga), an SGLT2 inhibitor, and extended-release metformin (Glucophage XR and others).
In the process of filtering the blood, the kidneys typically reabsorb all the filtered glucose and return it to the bloodstream. One of the main proteins responsible for this reabsorption is SGLT2. By inhibiting the action of SGLT2, Farxiga blocks the reabsorption of glucose by the kidneys, promoting a loss of glucose in the urine and lowering blood glucose levels. Metformin works by decreasing the amount of glucose made by the liver and by improving insulin sensitivity in the liver, muscle, and fat cells.
Xigduo XR, the first once-daily combination tablet of an SGLT2 inhibitor and extended-release metformin approved in the United States, will be offered in doses of 5 milligrams of dapagliflozin/500 milligrams of metformin, 5 milligrams of dapagliflozin/1,000 milligrams of metformin, 10 milligrams of dapagliflozin/500 milligrams of metformin, and 10 milligrams of dapagliflozin/1,000 milligrams of metformin to be taken once a day in the morning with food.
This medicine should not be used in people with Type 1 diabetes, diabetic ketoacidosis (a potentially life-threatening condition marked by a chemical imbalance in the body), or moderate to severe kidney impairment. Because of the inclusion of metformin, Xigduo XR carries the risk of a rare but serious metabolic complication known as lactic acidosis.
The most commonly reported side effects of Farxiga plus metformin compared to placebo (inactive treatment) plus metformin include female genital fungal infections, inflammation of the nasal passages and upper pharynx, urinary tract infections, diarrhea, and headache. The most commonly reported side effects of extended-release metformin compared to placebo are diarrhea and nausea/vomiting.
For more information about Xigduo XR, see the press release on the AstraZeneca website.