Efficacy and safety of dapagliflozin plus saxagliptin vs insulin glargine over 52 weeks as add-on to metformin with or without sulfonylurea in patients with type 2 diabetes: A randomized, parallel-design, open-label, phase 3 trial
Diabetes, Obesity and Metabolism Feb 07, 2020
Vilsbøll T, Ekholm E, Johnsson E, et al. - In this 52-week extension study, the safety and effectiveness of dapagliflozin plus saxagliptin (DAPA+SAXA) were contrasted to insulin glargine (INS) in individuals with type 2 diabetes (T2D). Adults with T2D on metformin with/without sulfonylurea received DAPA+SAXA or INS in this international, randomized, Phase 3, 24-week (short-term) study with a 28-week (long-term) extension. Of the 1,163 individuals recruited, 643 received treatment. In patients with T2D 52 weeks after initiation, DAPA+SAXA treatment was non-inferior to INS in decreasing HbA1c and body weight, and in obtaining optimal glycemic control without hypoglycemia.
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