Efficacy and safety of dapagliflozin plus saxagliptin versus insulin glargine over 52 weeks as add‐on to metformin with or without sulphonylurea in patients with type 2 diabetes: A randomized, parallel‐design, open‐label, Phase 3 trial

AIM: Efficacy and safety of dapagliflozin plus saxagliptin (DAPA + SAXA) were compared with insulin glargine (INS) in patients with type 2 diabetes (T2D) in a 52‐week extension study. MATERIALS AND METHODS: This international Phase 3 study randomized adults with T2D on metformin with/without sulphonylurea. They received DAPA + SAXA or INS for 24 weeks (short‐term) with a 28‐week (long‐term) extension. Week 52 exploratory endpoints included adjusted mean change from baseline in glycated haemoglobin A(1c) (HbA1c) and body weight, and a proportion of patients achieving optimal glycaemic response without hypoglycaemia and without requiring rescue medication. RESULTS: Of the 1163 patients enrolled, 643 received treatment; 600 (DAPA + SAXA, 306; INS, 294) entered the long‐term phase. At 52 weeks, HbA1c [adjusted least squares (LS) mean; 95% confidence interval (CI)] decreased more with DAPA + SAXA (−1.5% [−1.6%, −1.4%]) than with INS (−1.3% [−1.4%, −1.1%]); the LS mean difference (95% CI) was −0.25% (−0.4%, −0.1%; P = 0.009). Total body weight reduced with DAPA + SAXA [LS mean (95% CI): −1.8 kg (−2.4, −1.3)] and increased with INS [LS mean (95% CI): +2.8 kg (2.2, 3.3)]. More patients on DAPA + SAXA (17.6%) achieved HbA1c <7.0% without hypoglycaemia versus those on INS (9.1%). Rescue medication was required by 77 patients (23.8%) and 97 patients (30.4%) in the DAPA + SAXA and INS groups, respectively. CONCLUSION: DAPA + SAXA treatment was non‐inferior to INS in reducing HbA1c and body weight, and in achieving optimal glycaemic control without hypoglycaemia in patients with T2D 52 weeks after initiation.