FDA approves combination drug for better blood sugar control in Diabetes

The U.S Food and Administration has approved a combination drug formula called Qternmet XR which is dapagliflozin, saxagliptin and metformin hydrochloride, extended-release tablet for better management of blood sugar in adults with type 2 diabetes. The extended-release tablet is an oral adjunct treatment to diet and exercise to improve blood sugar control in adults with type-2 diabetes (T2D).

The approval is based on two Phase III trials, which evaluated combinations of dapagliflozin and saxagliptin on a background of metformin over 24 weeks, in patients with inadequately-controlled T2D.Qternmet XR has been developed by AstraZeneca.

Qternmet XR is a concoction of multiple active pharmaceutical ingredients which has been proven to control blood sugar in type2 diabetes patients. The concoction includes dapagliflozin, saxagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and metformin, a biguanide for having inadequate blood sugar control with either single drug or two drugs.

Initiation with Qternmet XR is indicated in only those, who are under metformin medication.

Sodium-glucose co-transporter 2 (SGLT2) inhibitors reduce cardiovascular events and decrease the body fat mass in patients with type 2 diabetes mellitus (T2DM). Dapagliflozin belongs to a new generation of diabetes medicines called selective SGLT2 inhibitors that work in the kidneys to prevent glucose resorption from the urine into the bloodstream. Dapagliflozin is already authorized in the European Union as Forxiga and Edistride for the treatment of patients with type 2 diabetes. Saxagliptin once-daily dipeptidyl peptidase-4 (DPP-4) inhibitor indicated for improving glycemic control in patients with type 2 diabetes. saxagliptin increases and prolongs the effects of incretins, a group of peptide hormones released by intestinal cells after meals, which stimulate glucose-dependent insulin secretion to lower blood glucose.

In one study, addition of dapagliflozin 5mg/saxagliptin 5mg in addition to metformin resulted in statistically significant decreases in HbA1c , compared with dapagliflozin alone and metformin or saxagliptin alone and metformin. Moreover, a significant patient getting dapagliflozin and saxagliptin + metformin medication achieved the therapeutic glycemic goal of HbA1c vs those in the dapagliflozin alone in addition, to metformin and saxagliptin alone, in addition, to metformine.

A second study showed that the addition of dapagliflozin 10mg and saxagliptin 5mg in addition to metformin resulted in statistically significant decreases in HbA1c compared with dapagliflozin + metformin or saxagliptin + metformin.

The drug will be supplied in the form of 4 tablet strengths having dapagliflozin 2.5mg/saxagliptin 2.5mg/metformin HCl 1000mg; 5mg/2.5mg/1000mg; 5mg/5mg/1000mg; and 10mg/5mg/1000mg.