The U.S. Food and Drug Administration has approved INVOKAMET™, a fixed-dose therapy combining canagliflozin and metformin hydrochloride in a single tablet, for the treatment of adults with type 2 diabetes. INVOKAMET provides the clinical attributes of INVOKANA® (canagliflozin), the first sodium glucose co–transporter 2 (SGLT2) inhibitor available in the United States, together with metformin, which is commonly prescribed early in the treatment of type 2 diabetes.
INVOKAMET is the first fixed–dose combination of an SGLT2 inhibitor with metformin approved in the United States. The co–administration of INVOKANA and metformin has been studied in six Phase 3 clinical studies that enrolled 4,732 patients with type 2 diabetes. The Phase 3 studies evaluated INVOKANA in combination with metformin compared to metformin alone or to metformin plus another diabetes therapy.
The studies were part of the comprehensive global Phase 3 program for INVOKANA that enrolled 10,285 patients, one of the largest clinical programs in type 2 diabetes submitted to health authorities to date. The Phase 3 studies showed that the combination of INVOKANA and metformin lowered blood sugar and, in pre–specified secondary endpoints, was associated with significant reductions in body weight and systolic blood pressure.
In two studies comparing INVOKANA plus metformin to current standard treatments plus metformin – one studying sitagliptin and the other studying glimepiride – INVOKANA dosed at 300 mg provided greater reductions in A1C levels and body weight than either comparator. A1C is the percent of red blood cell hemoglobin with glucose attached to it and an indicator of average blood glucose over the previous two to three months. In the two studies, the overall incidence of adverse events was similar with INVOKANA and the comparators.
INVOKAMET combines, in one tablet, two complementary therapeutic approaches proven effective for managing type 2 diabetes,” said Richard Aguilar, M.D., Medical Director of Diabetes Nation. “Canagliflozin works with the kidney to promote the loss of glucose in the urine, whereas metformin decreases the production of glucose in the liver and improves the body's response to insulin.”
INVOKAMET is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are not adequately controlled by treatment that includes either canagliflozin or metformin, or who are already being treated with both canagliflozin and metformin as separate medications. INVOKAMET should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. Study results demonstrated that administration of INVOKAMET was equivalent to co-administration of corresponding doses of canagliflozin and metformin as individual tablets.
INVOKAMET will be available in tablets containing canagliflozin 50 milligrams (mg) or 150 mg, and metformin 500 mg or 1000 mg. The recommended dosing is twice daily. The prescribing information for INVOKAMET also contains a boxed warning for lactic acidosis, a rare, but serious complication that can occur due to metformin accumulation.
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