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New Diabetes Combination Drug

Dec 6, 2013
Metformin may have a new partner…. 

Sodium glucose transporter 2 (SGLT2) inhibitors are all the buzz in the world of diabetes with the first in class drug, canagliflozin (Invokana ®), approved for use in the US earlier this year. As of right now, the SGLT2 inhibitors are being used as an add-on drug to already existing primary therapy when the primary drug regimen alone is not effective in helping patients reach their blood glucose goals. But now, there is a new combination drug containing dapagliflozin, an SGLT2 inhibitor, and metformin produced by AstraZeneca/Bristol-Myers Squibb, Xigduo®, which is close to approval for use in Europe. Xigduo, indicated for those who are >18 years old with type 2 diabetes, will come in 2 strengths of film-coated tablets: 5-mg dapagliflozin/850-mg metformin, and 5-mg/1000-mg, with twice a day dosing recommendations and thus lowering pill burden for many patients.

The problem? This is in Europe, not the US. However, AstraZeneca/Bristol-Myers Squibb are anxiously awaiting the approval of dapagliflozin (Forxiga®) in the US. So far they have received positive feedback from the FDA and an advisory committee meeting set for December 12th may give them more indication of if/when their drug will hit the US market. If dapagliflozin is approved, maybe we will see the push for Xigduo to come to the US market too.

Patients with diabetes often require more than 1 drug to appropriately manage and control their diabetes however increased pill burden can lead to decreased compliance and decreased ability to meet their diabetes goals. The combination of metformin, our current primary drug choice, and a SGLT2 inhibitor, which has been associated with weight loss and lowering blood glucose, may provide a nice treatment option for many who suffer from type 2 diabetes. With metformin reducing hepatic glucose production and with dapagliflozin increasing urinary glucose excretion, the dual action combination pill will be one to watch for.

Practice Pearls:
  • SGLT2 inhibitors are the newest class of drugs to come to US market with only 1 currently being approved in the US: canagliflozin (Invokana ®) and dapagliflozin (Forxiga®) potentially on the horizon.
  • SGLT2 inhibitors work by blocking the reabsorption of glucose in the proximal portion of the distal tubule in the kidney, thus increasing excretion of urinary glucose.
  • The combination pill of metformin/dapagliflozin (Xigduo®) is nearing approval in Europe and could reduce pill burden for many type 2 diabetes patients.

Xigduo (dapagliflozin/metformin) Summary of Opinion. European Medicines Agency and Committee for Medicinal Products for Human Use EMA/CHMP/703245/2013. 21 November 2013