Empagliflozin in combination with oral agents in young and overweight/obese Type 2 diabetes mellitus patients: a pooled analysis of three randomized trials

Abstract

Aims This analysis aimed to evaluate efficacy and safety of empagliflozin in combination therapy in < 65 y.o. patients, overweight/obese, and with uncontrolled T2DM. Methods Pooled analysis from three phase-III trials, in < 65 y.o. patients, with BMI 25–35 kg/m2, and HbA1c ≥ 8% at baseline. Patients (N = 439) were randomized to placebo (n = 138), empagliflozin 10 mg (n = 160), or empagliflozin 25 mg (n = 141) once daily (24 weeks) as add-on to metformin, to metformin plus sulfonylurea, or to pioglitazone ± metformin. Results At week 24, adjusted mean (SE) changes from baseline in HbA1c were − 0.19% (0.07) for placebo vs. − 1.10% (0.07) and − 1.10% (0.07) for empagliflozin 10 and 25 mg, respectively (both p < 0.001). Adjusted mean (SE) changes from baseline in weight were − 0.33 kg (0.21) for placebo vs. -1.94 kg (0.19) and − 2.14 kg (0.20) for empagliflozin 10 and 25 mg, respectively (both p < 0.001). Adverse events were reported in 57.2% on placebo, 64.4% on empagliflozin 10 mg and 59.6% on empagliflozin 25 mg. Genital infection AEs were reported in 1.4% on placebo, 3.8% on empagliflozin 10 mg, and 5.0% on empagliflozin 25 mg. Conclusions In this specific population, empagliflozin in combination with other oral agents, significantly reduced HbA1c and body weight and was well tolerated.