Qtern(saxagliptin and dapagliflozin)

Qtern is a fixed-dose combination drug containing saxagliptin (5 mg) and dapagliflozin (10 mg) per tablet, indicated for the treatment of type 2 diabetes. Its shelf life is 3 years.

In a multicentre, randomised, double-blind, active-controlled, parallel-group, 24-week Phase 3 trial, the primary endpoint was the mean change from baseline in HbA1c. Qtern (saxagliptin + dapagliflozin + metformin) demonstrated an HbA1c change from baseline of -1.47%. This compared to a change of -0.88% for dapagliflozin added to metformin and -1.20% for saxagliptin added to metformin. The difference in HbA1c change from baseline for Qtern versus dapagliflozin added to metformin was -0.59%, and versus saxagliptin added to metformin was -0.27%. Additionally, 41.8% of patients achieved HbA1c < 7%.

Safety data from a treated subjects dataset (N=1169) with a median exposure of 169 days showed that 594 subjects reported at least one adverse event. Among those receiving saxagliptin + dapagliflozin + metformin (N=492), 250 subjects reported at least one adverse event. Headache incidence for saxagliptin + metformin was 4.2%.