Empagliflozin (EMPA) Compared with Glimepiride (GLIM) as Add-On to Metformin (MET) for 2 Years in Patients with Type 2 Diabetes (T2DM)

We performed a phase III trial, EMPA-REG H2H-SUTM, comparing the efficacy and safety of EMPA and GLIM as add-on to MET in patients with T2DM (mean ± SD age 55.9±10.4 years; BMI 30.1±5.3 kg/m2). Patients were randomized and treated double-blind with EMPA 25 mg (n=765) or GLIM 1–4 mg (n=780) for 104 weeks. Primary endpoint was change from baseline in HbA1c. Key secondary endpoints were change from baseline in weight, occurrence of confirmed hypoglycemic adverse events (AEs; glucose ≤3.9 mmol/L and/or requiring assistance) and changes from baseline in systolic and diastolic blood pressure (SBP and DBP).