New Metformin Combination Medicine Approved for Type 2 Diabetes

On August 27, the U.S. Food and Drug Administration (FDA) approved the combination oral diabetes medicine Synjardy for use, along with a healthful diet and exercise, in adults with Type 2 diabetes. Synjardy, a joint development of Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company, combines empagliflozin (brand name Jardiance), an SGLT2 inhibitor, and metformin (brand name Glucophage 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, Jardiance 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.

Synjardy, the third combination medicine containing empagliflozin approved in the United States, will be offered in doses of 5 milligrams of empagliflozin/500 milligrams of metformin, 5 milligrams of empagliflozin/1,000 milligrams of metformin, 12.5 milligrams of empagliflozin/500 milligrams of metformin, and 12.5 milligrams of empagliflozin/1,000 milligrams of metformin, to be taken twice daily with meals.

The approval of Synjardy was based on results from multiple studies of empagliflozin and metformin alone or combined with a sulfonylurea that showed reductions in blood sugar levels compared to placebo (inactive treatment).

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 severe kidney problems. As with all medicines containing metformin, this drug contains a boxed label warning on the risk for a rare but serious complication known as lactic acidosis (a buildup of lactic acid in the bloodstream).

The most commonly reported side effects of Synjardy include stuffy or runny nose and sore throat, urinary tract infections, female genital infections, diarrhea, headache, nausea, and vomiting.

For more information about Synjardy, see the article on Medscape or the press release on the Eli Lilly website.