Xigduo Xr is indicated for the management of diabetes mellitus type 2, and functions to improve glycemic control in adults when combined with diet and exercise. Xigduo Xr is a sodium-glucose cotransporter 2 inhibitor, which prevents glucose reabsorption in the kidney. Using xigduo xr leads to heavy glycosuria (glucose excretion in the urine), which can lead to weight loss and tiredness. Xigduo Xr was approved by the FDA on Jan 08, 2014. Xigduo Xr is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Increases in the amount of glucose excreted in the urine were observed in healthy subjects and in patients with type 2 diabetes mellitus following the administration of xigduo xr. A Xigduo Xr dose of 10 mg per day in patients with type 2 diabetes mellitus for 12 weeks resulted in excretion of approximately 70 grams of glucose in the urine per day at week 12. A near maximum glucose excretion was observed at the xigduo xr daily dose of 20 mg. This urinary glucose excretion with xigduo xr also results in increases in urinary volume.
Compared to placebo-treated patients, patients with moderate renal impairment treated with xigduo xr did not have improvement in glycemic control and had more renal-related adverse reactions and more bone fractures; therefore, xigduo xr should not be initiated in this population. Based on its mechanism of action, xigduo xr is not expected to be effective in patients with severe renal impairment (eGFR less than 30 mL/min/1.73 m2) or ESRD.