Empagliflozin belongs to the class of sodium glucose co-transporter-2 (SGLT2) inhibitor compounds, and is being investigated for the reduction of blood glucose levels in adults with type 2 diabetes (T2D).
The emerging SGLT2 inhibitor class removes excess glucose through the urine by blocking glucose re-absorption by the kidney.
The phase III program enrolled more than 14,500 people and comprises more than 10 multinational clinical trials, including a large cardiovascular outcome trial.
Results of the 52-week randomized, double-blind, placebo-controlled study showed a significant reduction in body weight and blood pressure with empagliflozin versus placebo in patients with mild to moderate kidney impairment.
Adverse events (AEs) were noted in 79.6%, 75.4 % and 72.7% of patients at 24 weeks with empagliflozin 10 mg, empagliflozin 25 mg and placebo, respectively.
Empagliflozin statistically proved significant reductions in HbA1c (average blood glucose) at week 24, with the addition of empagliflozin to existing oral antihyperglycemic therapy in adults with type 2 diabetes (T2D) and mild to moderate kidney impairment (eGFR > /=60 to < 90 ml/min/1.73 m2 and eGFR > /=30 to < 60 ml/min/1.73 m2).
Results of the study with empagliflozin in patients with renal impairment included the exploratory endpoints such as decrease in fasting blood glucose (FPG) levels in patients with mild renal impairment of 13.88 mg/dL and 18.08 mg/dL (p < 0.001) for empagliflozin 10 mg and 25 mg, respectively.
Similarly, an increase of 5.67 mg/dL for placebo; in patients with moderate renal impairment, a decrease in FPG levels of 9.26 mg/dL (p < 0.001) for empagliflozin 25 mg and an increase of 10.16 mg/dL for placebo.