Abstract
AIMS: To analyse the effect of baseline glycated haemoglobin (HbA(1c)) on the reduction in HbA(1c) with empagliflozin compared with sitagliptin or glimepiride in patients with type 2 diabetes. MATERIALS AND METHODS: Using regression analyses of individual patient data from two Phase III studies, we compared the change in HbA(1c) according to a unit change in baseline HbA(1c) (the slope) with empagliflozin 10 mg or 25 mg vs sitagliptin (monotherapy) after 24 weeks, and with empagliflozin 25 mg vs glimepiride (as add-on to metformin) after 52 weeks. RESULTS: Steeper slopes of HbA1c decline were observed with empagliflozin 10 or 25 mg vs sitagliptin monotherapy at week 24. Regression analysis showed slopes of -0.59 (95% CI -0.70, -0.47), -0.49 (95% CI -0.62, -0.37) and -0.29 (95% CI -0.42, -0.15) for empagliflozin 10 mg, empagliflozin 25 mg and sitagliptin, respectively (P < .001 and P < .05 for empagliflozin 10 mg and empagliflozin 25 mg, respectively, vs sitagliptin). Similarly, a steeper slope of HbA(1c) decline was observed with empagliflozin 25 mg vs glimepiride as add-on to metformin at week 52. Regression analysis showed slopes of - 0.52 (95% CI -0.59, -0.44) and -0.32 (95% CI -0.39, -0.25) for empagliflozin 25 mg and glimepiride, respectively (P < .001 for empagliflozin 25 mg vs glimepiride). CONCLUSIONS: Incremental reductions in HbA(1c) with increasing baseline HbA(1c) are greater with empagliflozin compared with sitagliptin or glimepiride in patients with type 2 diabetes.