A Phase 3 clinical trial, DERIVE, assessing AstraZeneca’s (AZN -0.1%) FARXIGA (dapagliflozin 10 mg) in patients with type 2 diabetes with moderate renal impairment met the primary and secondary endpoints. The data were presented at the Endocrine Society Annual Meeting in Chicago.
Treatment with dapagliflozin, an SGLT2 inhibitor, produced a statistically significant reduction in HbA1C versus placebo (-0.37% vs. -0.03%; p<0.001).
It also produced a statistically significant average reduction in body weight (-3.17 kg vs. -1.92 kg; p<0.001), mean fasting glucose from baseline to week 24 (-21.46 mg/dL vs. -4.87 mg/dL; p=0.001) and mean systolic blood pressure from baseline to week 24 (-4.8 mm Hg vs. -1.7 mm Hg; p<0.05).
The FDA approved FARXIGA in January 2014.