Fixed-dose combinations (FDCs) of empagliflozin and linagliptin significantly improved glycemic control in patients with (T2DM) on stable metformin therapy. Presented at the European Association for the Study of Diabetes (EASD) 2025, a Phase III study evaluated the efficacy and safety of this particular combination.
In this 52-week randomized, double-blind trial, 674 participants received either EMPA 25 mg/LINA 5 mg, EMPA 10 mg/LINA 5 mg, EMPA alone, or linagliptin 5 mg. Both EMPA/LINA FDCs achieved greater reductions in HbA1c compared with monotherapies and allowed a higher proportion of patients to reach target HbA1c <7%. Body weight decreased by up to 3.2 kg with EMPA/LINA FDCs compared with linagliptin alone. Systolic blood pressure dropped by 2.8–3.6 mmHg and diastolic blood pressure by 1.8–2.2 mmHg across FDC groups.
Confirmed hypoglycemia occurred in fewer than 4% of participants without requiring assistance. Rates of urinary and genital infections were similar to individual therapies. These findings highlight that EMPA/LINA FDCs provide effective glycemic control and additional metabolic benefits as an add-on to metformin in patients with T2DM.