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Submitted by PatientsEngage on 1 November 2014

U.S. Food and Drug Administration has approved once-daily XIGDUO™ XR (dapagliflozin and metformin hydrochloride extended-release) for the treatment of adults with type 2 diabetes. It is already approved in Australia

XIGDUO XR combines two anti-hyperglycemic agents with complementary mechanisms of action, dapagliflozin (trade name in the U.S. FARXIGA™), an inhibitor of sodium-glucose cotransporter 2 (SGLT2), and metformin hydrochloride (HCl) extended-release, a biguanide, in a once-daily oral tablet. SGLT2 inhibitors are a relatively new class of medicines that remove glucose from the body via the kidneys.

XIGDUO XR is the first and only once-daily combination tablet of an SGLT2 inhibitor and metformin HCl extended-release to be approved in the United States. XIGDUO XR is indicated as an adjunct therapy to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both dapagliflozin and metformin is appropriate.

XIGDUO XR is not recommended for patients with type 1 diabetes or diabetic ketoacidosis. The product label for XIGDUO XR contains a boxed warning for lactic acidosis, a rare, but serious metabolic complication that can occur due to metformin accumulation during treatment with XIGDUO XR.

XIGDUO XR is contraindicated in patients with moderate to severe renal impairment; a history of a serious hypersensitivity to dapagliflozin or to metformin HCl; or with metabolic acidosis, including diabetic ketoacidosis.

Diabetologist Dr. Venkat Rao says "This is a new kid on the block. DAPAGLIFLOZIN is a molecule, which acts in the kidney on a receptor called SGLT2, thereby not allowing the glucose to be reabsorbed in to the system 
and enhancing glucose excretion. Even though the science behind this mechanism was already being analysed as early as 1970, it has only now become reality.
Basically, the kidney filters all the unwanted stuff; glucose is excreted in the same process. The kidney also has a mechanism by which essential substances that are thrown out are reabsorbed in to the body. The medicine acts at this level by not allowing the glucose to be re-absorbed. This makes the kidney excrete more glucose, thus reducing blood glucose levels.
As much as 200-300 calories a day can be the weight loss due to these medications. As these do not interfere in insulin secretion these are believed to work well without causing low blood sugars.
This drug has two other associated advantages: calorie loss, so one can expect some weight loss, and blood pressure control. When the glucose is excreted, it pulls some water from the system, which benefits blood pressure. 

A word of caution: A common adverse event with this molecule would be more urinary tract infection due to excess glucose in urine.The science behind this looks interesting and it appears to be a safe medicine but since this is a new molecule, time has to answer for the true benefits...and long term effects."
 

For more details read :

http://www.fiercebiotech.com/press-releases/us-fda-approves-once-daily-xigduo-xr-tablets-adults-type-2-diabetes-0

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