AstraZeneca PLC's Farxiga reduced blood sugar levels in a phase 3 study of certain patients with type 2 diabetes with stage 3A chronic kidney disease.
Farxiga, or dapagliflozin, is a sodium-glucose co-transporter 2, or SGLT2, inhibitor, and belongs to a class of prescription medicines that are approved by the U.S. Food and Drug Administration for use with diet and exercise to lower blood sugar in adults with type 2 diabetes.
The trial randomized 321 patients with type 2 diabetes and stage 3A chronic kidney disease from eight countries and treated them with either Farxiga 10 milligrams or placebo over 24 weeks.
In the U.S., 30.3 million people in the U.S. have diabetes, and type 2 diabetes accounts for 90% to 95% of all diabetes cases, the company reported, citing the U.S. Centers for Disease Control and Prevention.
Farxiga reduced mean HbA1C, or glycated hemoglobin, levels by 0.37%, compared with a 0.03% reduction in patients on placebo.
Glycated hemoglobin develops when hemoglobin, a protein within red blood cells that carries oxygen throughout the body, joins with glucose in the blood. It provides a longer-term trend, similar to an average, of how high blood-sugar levels have been over a period of time.
The drug also reduced mean body weight by 3.17 kg, versus a reduction of 1.92 kg seen in the placebo group. In addition, Farxiga significantly reduced mean systolic blood pressure and mean fasting plasma glucose compared to placebo.
Farxiga is already approved to be used in combination with diet and exercise to improve glycemic control in adults with type 2 diabetes.
AstraZeneca plans to submit the results to the FDA to add to data already contained within the existing Farxiga prescribing information.