As the SGLT2 race for diabetes turns hot, AstraZeneca — one of the earliest players in the field — has laid out data demonstrating its drug’s benefits for a subset of type 2 diabetics.
Farxiga (dapagliflozin) was compared against a placebo among type 2 diabetes patients with a moderate stage of chronic kidney disease in a Phase III study dubbed Derive. The 321-patient study met its primary endpoint of changing hemoglobin A1C (HbA1C) and all three of its secondary endpoints.
At week 24, mean HbA1C dropped by 0.37% in the drug arm versus 0.03% in the placebo arm, with p<0.001.
Investigators also tracked significant reductions in body weight, fasting plasma glucose, and systolic blood pressure. The dapagliflozin group averaged a weight loss of 3.17 kg versus 1.92 kg; their mean fasting plasma glucose was cut by 21.46 mg/dL, a big difference from the placebo arm’s 4.87 mg/dL; and reduction in their systolic blood pressure came in at 4.8 mm Hg, compared to 1.7 mm Hg in the placebo group.
Adverse events related to study treatment — mostly urinary tract infection and pollakiuria — were reported in 10.6% of patients taking dapagliflozin and 6.2% of those with placebo.
All of this data, presented at the Endocrine Society’s annual meeting, will be submitted to the FDA, which approved the drug to treat type 2 diabetes back in 2014.
While cardio has been a major battlefield for SGLT2 diabetes drug makers, patients with renal impairment also constitute a significant slice of the market. According to AstraZeneca, type 2 diabetes is the leading cause of chronic kidney disease in the US with over 40% of patients affected, and “sustaining control of diabetes can help lower patients risk of developing severe kidney disease.”
“We are committed to helping patients with complex and comorbid diseases like T2D and chronic kidney disease, which is demonstrated through the breadth of our research and our unique cardiovascular, renal and metabolic approach,” said Jim McDermott, VP of US medical affairs, diabetes at AstraZeneca. “The Derive study will help us learn more and provide additional data for Farxiga in T2D.”
The best place to read Endpoints News? In your inbox.
Comprehensive daily news report for those who discover, develop, and market drugs. Join 35,100+ biopharma pros who read Endpoints News by email every day.Free Subscription