On February 28, the U.S. Food and Drug Administration (FDA) approved the combination oral diabetes medication Qtern for use, along with a healthful diet and exercise, in adults with Type 2 diabetes who do not have adequate blood glucose control with dapagliflozin (10 milligrams, brand name Farxiga) or who already take dapagliflozin and saxagliptin (Onglyza). The medicine, a development of AstraZeneca, combines dapagliflozin, an SGLT2 inhibitor, and saxagliptin, a DPP-4 inhibitor.
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, dapagliflozin blocks the reabsorption of glucose by the kidneys, promoting a loss of glucose in the urine and lowering blood glucose levels.
DPP-4 inhibitors such as saxagliptin work to lower blood glucose by blocking the action of an enzyme known as dipeptidyl peptidase 4, or DPP-4. DPP-4 breaks down hormones called incretins, which stimulate the release of insulin, slow stomach emptying, inhibit the release of glucagon (a hormone that signals the liver to release glucose), and enhance the survival and growth of the insulin-producing beta cells. With DPP-4 inhibited, the incretins have longer to carry out these actions.
The approval was based on results from a 24-week study that evaluated the safety and effectiveness of saxagliptin added to dapagliflozin in 315 adults with Type 2 diabetes who did not achieve adequate blood glucose control on metformin, as well as a safety analysis from three clinical trials in which 492 participants were treated with the medicine for up to 52 weeks.
Qtern will be offered in a dose of 10 milligrams of dapagliflozin with 5 milligrams of saxagliptin, to be taken once a day in the morning.
This medicine should not be used in people who have Type 1 diabetes, diabetic ketoacidosis (a potentially life-threatening condition marked by a chemical imbalance in the body), moderate to severe kidney problems or kidney failure, or in those who are on dialysis. The most commonly reported side effects of Qtern are urinary tract infection, upper respiratory tract infection, and abnormal levels of blood fats.
For more information about Qtern, see the press release on the AstraZeneca website.
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