(RxWiki News) A healthy diet and regular exercise are the mainstays of treatment for people with Type 2 diabetes. But when diet and exercise aren't enough to control blood sugar, diabetes patients may need medication — and they just got a new option.
The US Food and Drug Administration (FDA) has approved Invokamet, a tablet that combines canagliflozin and metformin hydrochloride, to treat adults with Type 2 diabetes.
"Ask your pharmacist about new medication options for diabetes."
Invokamet is marketed by Janssen Pharmaceuticals.
In March 2013, the FDA approved Janssen's Invokana (canagliflozin) to treat Type 2 diabetes. Invokamet combines canagliflozin, the first SGLT2 inhibitor, with metformin, the oldest diabetes medication.
In a Janssen press statement, Richard Aguilar, MD, medical director of Diabetes Nation, explained the new combination medication.
"Invokamet combines, in one tablet, two complementary therapeutic approaches proven effective for managing type 2 diabetes," Dr. Aguilar said. "Canagliflozin works with the kidney to promote the loss of glucose [blood sugar] in the urine, whereas metformin decreases the production of glucose in the liver and improves the body's response to insulin."
Invokamet will be available in tablets containing canagliflozin at either 50 or 150 milligrams and metformin at 500 or 1,000 milligrams.
The approval of Invokamet comes after six Phase 3 clinical trials of Invokana plus metformin. Those trials included more than 4,700 people with Type 2 diabetes. According to the Janssen press release, the trials showed that treatment with Invokana plus metformin lowered blood sugar and was associated with reductions in body weight and systolic blood pressure (the top number in a blood pressure reading).
Also according to Janssen, the most common side effects in the Phase 3 trials were female genital fungal infections, urinary tract infections and increased urination.