The film-coated tablets contain 5mg saxagliptin, a dipeptidyl peptidase 4 inhibitor, plus 10mg dapagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor. Qtern is also licensed for use in patients already being treated with the free combination of the components.
The safety and efficacy of the saxagliptin/dapagliflozin fixed-dose combination was evaluated in three phase III studies involving 1,169 adults with type II diabetes.
In a 24-week trial (n=534) patients with type II diabetes inadequately controlled on metformin monotherapy were randomised to receive add-on therapy with saxagliptin/dapagliflozin (5mg/10mg, n=179), saxagliptin 5mg (n=176) or dapagliflozin 10mg (n=179).
Patients receiving add-on therapy with the saxagliptin/dapagliflozin combination achieved significantly greater reductions in HbA1c from baseline to week 24 than those receiving saxagliptin or dapagliflozin (-1.47 versus -0.88 [p<0.0001] and -1.20 [p=0.0166], respectively).
In another 24-week study involving 320 patients inadequately controlled on saxagliptin 5mg plus metformin the addition of dapagliflozin 10mg to therapy was associated with a significantly greater reduction in HbA1c at week 24 than the addition of placebo (p<0.0001). The effect on HbA1c observed at week 24 was sustained at week 52.
Similarly, in a 24-week trial involving 315 patients inadequately controlled on dapagliflozin 10mg plus metformin, patients who received add-on therapy with saxagliptin 5mg achieved significantly greater reductions in HbA1c at week 24 than those who received placebo (p<0.0001), an effect that was sustained at week 52.
The safety profile of the saxagliptin/dapagliflozin combination in these clinical studies for up to 52 weeks was comparable to those of the individual components.