Combined SGLT2 inhibitor and DPP-4 inhibitor approved for type 2 diabetes

A new fixed-dose tablet combining the sodium glucose co-transporter 2 (SGLT2) inhibitor empagliflozin with the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin has been granted marketing authorisation by the European Commission. Glyxambi is indicated for use in adults with type 2 diabetes to improve glycaemic control when metformin and/or a sulfonylurea plus either empagliflozin or linagliptin do not provide adequate glycaemic control, or if the patient is already taking empagliflozin plus linagliptin as a free combination. This is the first SGLT2 inhibitor/DPP-4 inhibitor combination to be approved in the EU; previously, SGLT2 inhibitor and DPP-4 inhibitor drugs have only been available alone or in combination with metformin.

The oral combined treatment contains either 10mg or 25mg empagliflozin and 5mg linagliptin. The recommended starting dosage is 10mg/5mg once daily; this can be increased to 25mg/5mg once daily if tolerated and additional glycaemic control is required. The two drugs improve glycaemic control by complementary mechanisms of action. Empagliflozin selectively inhibits SGLT2, the major co-transporter for renal glucose reabsorption, thus increasing the excretion of glucose in the urine. Linagliptin works by inhibiting the enzyme DPP-4, which is involved in the inactivation of the incretins glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), thus increasing levels of active incretins, which help to regulate glucose homeostasis.

Data from phase 3 clinical trials have shown that in patients with type 2 diabetes and inadequate glycaemic control taking metformin therapy, six months treatment with empagliflozin/linagliptin as add-on therapy produced significant improvements in HbA1c and fasting plasma glucose compared with linagliptin or empagliflozin alone as add-on therapy (p<0.0001). Trials also showed that the safety profile of the combined therapy was similar to that of the individual components. The most common side-effect was urinary tract infection and the most serious adverse reactions were ketoacidosis, pancreatitis, hypersensitivity and hypoglycaemia.

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