AstraZeneca announced new data evaluating the safety and efficacy of dapagliflozin (Farxiga) in patients with type 2 diabetes (T2D) with moderate renal impairment. Full findings were presented at the Endocrine Society annual meeting (ENDO).
The Phase 3 DERIVE trial (N=321) randomized patients with T2D (HbA1c 7–11%) and stage 3A chronic kidney disease (CKD) with eGFR 45–59mL/min/1.73m2 to either dapagliflozin 10mg or placebo for 24 weeks. Compared to placebo, treatment with dapagliflozin resulted in a significant decrease in mean HbA1c (-0.37% vs -0.03%; difference -0.34%; P<0.001) and mean body weight (-3.17kg vs -1.92kg; difference -1.25kg; P<0.001) from baseline to Week 24.
The mean fasting plasma glucose was also significantly lowered with dapagliflozin vs placebo (-21.46mg/dL vs -4.87mg/dL) as was mean systolic blood pressure (-4.8mmHg vs -1.7mmHg) from baseline to Week 24.
Regarding safety, dapagliflozin lowered the mean eGFR by -3.2mL/min/1.73m2 vs -0.63mL/min/1.73m2 in placebo. Adverse events occurred in 41.9% of dapagliflozin-treated patients vs 47.8% of placebo patients. Urinary tract infection and pollakiuria were the most common treatment-related events.
Farxiga is a sodium-glucose co-transporter 2 (SGLT2) inhibitor currently indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2D mellitus. It is available as 5mg and 10mg strength tablets.
For more information call (800) 237-8898 or visit AstraZeneca-US.com.