Effectiveness and safety of empagliflozin‐based quadruple therapy compared with insulin glargine‐based therapy in patients with inadequately controlled type 2 diabetes: An observational study in clinical practice

Abstract

This open‐label, prospective study evaluated the effectiveness and safety of empagliflozin as add‐on therapy in inadequately controlled type 2 diabetes (T2D) patients (glycated haemoglobin [HbA1c], 7.5‐12%) who were already using three other types of orally active antidiabetic agents. A total of 268 T2D patients were enrolled and divided into two groups, empagliflozin (EMPA 25\u2009mg/d, n\u2009=\u2009142) or insulin glargine (INS, n\u2009=\u2009126), respectively. After the treatment period of 24\u2009weeks, HbA1c and fasting plasma glucose (FPG) were significantly reduced (HbA1c, P\u2009=\u20090.004; FPG, P\u2009=\u20090.008, respectively) in the EMPA group compared to the INS group. Also, EMPA treatment evoked a significant reduction in body weight (P\u2009<\u20090.001) and systolic blood pressure (P\u2009=\u20090.017) compared to the INS group. Hypoglycaemic adverse events were significantly higher in the INS group compared to the EMPA group (P\u2009=\u20090.001). In conclusion, this study demonstrated that a regimen comprising four different orally active antidiabetic agents, including EMPA, was effective and safe as a therapeutic strategy for treating T2D patients for glycaemic control and improvement of other cardiovascular and metabolic indices.