Adults in the UK with type II diabetes have gained a new treatment option to keep blood sugar levels under control with the launch of AstraZeneca's Qtern in the country.
Qtern is a once-daily fixed combination of saxagliptin 5mg, a dipeptidyl peptidase-4 (DPP-4) inhibitor, with dapagliflozin 10mg, a sodium-glucose co-transporter 2 (SGLT2) inhibitor.
The pill was approved by EU regulators in July for use in adults with type II diabetes to improve glycaemic control when metformin and/or sulphonylurea (SU) and one of the mono-components of Qtern do not provide adequate control, or when a patient is already being treated with the free combination of saxagliptin and dapagliflozin.
"DPP-4 inhibitors and SGLT2 inhibitors are commonly prescribed together as they have complementary mechanisms of action to help improve glycaemic control in people with type 2 diabetes. Being available together in a single tablet provides another treatment option that can help to improve glycaemic control while reducing the pill burden. As a complex, progressive disease with many comorbidities, this is a welcome development for patients," said Dr Luigi Gnudi, professor of Diabetes and Metabolic Medicine/honorary consultant in Diabetes and Endocrinology, and head of the Unit for Metabolic Medicine, Cardiovascular Division, King's College London, Guy's and St Thomas NHS Foundation Trust.
Qtern's approval was based on findings from three Phase III multi-centre clinical trials involving 1,169 adult subjects with the condition. 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.
Around 700 people a day are diagnosed with diabetes, which equates to one person every two minutes, and it is estimated that, by 2025, five million people will have the condition, according to Diabetes UK.
"Almost three-quarters (74 percent) of people with type II diabetes in the UK are not reaching the recommended HbA1c target of 6.5 percent, which means they are at increased risk of the complications associated with the condition," said Lisa Anson, country president, AstraZeneca UK.
"AstraZeneca is pleased to offer another treatment option in the diabetes portfolio to help patients reach their targets, enabling clinicians to continue oral therapy with a once-daily tablet."
The National Institute for Health and Care Excellence will not be appraising Qtern, so any decisions on its use in NHS England will be at local level. The Scottish Medicines Consortium (SMC) and All Wales Medicines Strategy Group (AWMSG) will assess the drug sometime this year.