The dual action drug combines the complementary mechanis of dapagliflozin (trade name in the US, FARXIGA™), which blocks a sodium-glucose co-transporter 2 (SGLT2), with extended-release metformin, which reduces the amount of sugar produced by liver cells. SGLT2 inhibitors are a relatively new class of medicines that remove glucose from the body via the kidneys.
The US FDA approved once-daily XIGDUO XR based upon four Phase III clinical trials, which provided clinical evidence for the effectiveness and safety of dapagliflozin and metformin IR or XR tablets in previously untreated patients, in patients inadequately controlled on metformin, as well as compared to a sulfonylurea (glipizide) plus metformin.
XIGDUO XR is already approved in Australia for the treatment of adults with type 2 diabetes, along with diet and exercise. XIGDUO (dapagliflozin and metformin hydrochloride), which uses an immediate-release form of metformin, is approved in the European Union.
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