The US Food and Drug Administration has now issued a green light for the use of AstraZeneca's diabetes combination therapy Qtern to treat patients with type II diabetes, having rejected it back in 2015 with a request for more clinical data.
The fixed-dose combination of the DPP-4 inhibitor saxagliptin and SGLT-2 inhibitor dapagliflozin offers a dual approach to lowering blood glucose levels.
The treatment is indicated as an adjunct to diet and exercise to improve glycaemic (blood sugar level) control in adults with type II diabetes who have inadequate control with dapagliflozin or who are already treated with dapagliflozin and saxagliptin.
"Type II diabetes is a complex disease that is at epidemic proportions, affecting more than 29 million people in the US alone. The approval of Qtern is good news for patients who may benefit from improved glycaemic control by adding a DPP-4 inhibitor to a SGLT-2 inhibitor in a convenient once-daily tablet," said Elisabeth Björk, vice president, head of Cardiovascular and Metabolic Diseases, Global Medicines Development at AZ.
The approval was based on data from a 24-week, Phase III, multi-centre, randomised, double-blind, placebo-controlled trial (n=315) designed to evaluate the efficacy and safety of saxagliptin added to dapagliflozin in adult patients with type II diabetes who experienced inadequate glycaemic control with metformin.
In one study where saxagliptin 5mg or placebo was added to patients treated with dapagliflozin 10mg and metformin, mean changes from baseline HbA1c were -0.51 percent and -0.16 percent respectively at 24 weeks.
Also, the proportion of patients achieving a HbA1c of less than 7 percent at week 24 was higher in the saxagliptin plus dapagliflozin plus metformin group (35.3 percent) compared to the placebo plus dapagliflozin plus metformin group (23.1 percent).
On the safety side, the pill's side effects were comparable to that of saxagliptin and dapagliflozin, AZ noted, the most frequently reported adverse reactions being hypoglycaemia (when used with a SU) and upper respiratory tract infection.