Xigduo XR (dapagliflozin + metformin hydrochloride)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved October 2014

Specific Treatments:

glycemic control in adults with type II diabetes

Therapeutic Areas

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General Information

Xigduo XR is a combination of dapagliflozin, an inhibitor of sodium-glucose cotransporter 2 (SGLT2), and metformin hydrochloride extended-release, a biguanide. SGLT2 inhibitors remove glucose from the body via the kidneys.

Xigduo XR is specifically indicated as an adjunct therapy to diet and exercise to improve glycemic control in adults with type II diabetes mellitus when treatment with both dapagliflozin and metformin is appropriate. 

Xigduo XR is supplied as a tablet for oral administration. The starting dose should be individualized based on each patient’s current treatment regimen. The maximum daily recommended dose is 10 mg for dapagliflozin and 2,000 mg for metformin HCl. Xigduo XR should be taken once daily in the morning with food with gradual dose escalation to reduce the risk of gastrointestinal side effects due to metformin. 

Clinical Results

The FDA approval of Xigduo XR was based on four Phase III clinical trials, which provided clinical evidence for the efficacy and safety of dapagliflozin and metformin IR or XR tablets in treatment-naïve patients, in patients inadequately controlled on metformin, as well as compared to a sulfonylurea (glipizide) plus metformin. There have been no clinical studies conducted with Xigduo XR combination tablets. Bioequivalence was demonstrated in healthy adults between Xigduo XR and dapagliflozin plus metformin XR as separate tablets.

Side Effects

Adverse reactions associated with the use of Xigduo XR may include, but are not limited to, the following:

  • hypoglycemia
  • gastrointestinal symptoms

Mechanism of Action

Xigduo XR combines two anti-hyperglycemic agents with complementary mechanisms of action, dapagliflozin, 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 class of medicines that remove glucose from the body via the kidneys.

Additional Information

For additional information regarding Xigduo XR or the improvement of glycemic control in adults with type II diabetes, please visit www.astrazeneca.com