On July 19, the U.S. Food and Drug Administration (FDA) expanded the approved use of the oral combination diabetes medicine Synjardy to include treatment of adults with Type 2 diabetes who have never previously taken medicine for the condition. 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.
The medicine can now be used, along with a healthful diet and exercise, by adults with Type 2 diabetes who are already being treated for the condition or who will be treated for the first time. The new use was approved based on results from a phase 3, double-blind, randomized, active-controlled study that looked at the safety and effectiveness of the medicine as a first therapy for people with diabetes compared with each of the medicines alone. The combination of 10 or 25 milligrams of empagliflozin with 1,000 or 2,000 milligrams of metformin was found to significantly reduce HbA1c levels (a measure of blood glucose control over the previous 2–3 months) at 24 weeks compared to the same doses of either medicine alone.
Synjardy is taken twice a day with meals and comes 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.
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. Like all medicines that contain metformin, this drug’s label includes a boxed warning on the risk for lactic acidosis, a rare but serious complication characterized by a buildup of lactic acid in the bloodstream.
The most commonly reported side effects of Synjardy include urinary tract infections, stuffy or runny nose and sore throat, female genital infections, headache, nausea, vomiting, and diarrhea.
For more information about Synjardy’s new indication, see the article “FDA OKs Metformin/Empagliflozin for Treatment-Naïve Diabetes” or the press release on the Eli Lilly website.
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