This international, multicenter, randomized, open-label phase 3b trial (NCT02551874) evaluated the efficacy and safety of dapagliflozin (DAPA) 10 mg/day plus saxagliptin (SAXA) 5 mg/day vs. titrated insulin glargine (INS) in patients with type 2 diabetes (T2D) poorly controlled by metformin (MET) ≥1500 mg/day ± sulfonylurea (SU) ≥50% maximum dose (A1C levels 8-12%). The primary end point was change in A1C from baseline to week 24; DAPA + SAXA was tested for non-inferiority vs. INS. Secondary end points were: change in body weight; proportions of patients a) with hypoglycemia, b) achieving A1C <7% without hypoglycemia, c) achieving A1C <7% at week 24; and change in 24-hour glucose at week 2 assessed by continuous glucose monitoring. Mean±SD baseline data were age 55.5±9.6 years; A1C 9.1±1.0%; BMI 32.2±5.3 kg/m2, and were similar in both arms. DAPA + SAXA resulted in non-inferior reductions in A1C without weight gain, reductions in mean 24-hour glucose, and was associated with a lower prevalence of hypoglycemia and a greater proportion of patients achieving A1C <7% without hypoglycemia vs. INS (Table); there were no additional safety concerns. DAPA + SAXA therapy resulted in similar glycemic control, prevented weight gain and reduced risk of hypoglycemia compared with titrated INS in patients with T2D poorly controlled by MET ± SU.
T. Vilsbøll: None. E. Ekholm: None. E.K. Johnsson: Employee; Self; AstraZeneca. N. Dronamraju: None. S. Jabbour: None. M. Lind: Consultant; Self; AstraZeneca. Research Support; Self; AstraZeneca. Consultant; Self; Novo Nordisk Inc.. Advisory Panel; Self; Novo Nordisk Inc.. Research Support; Self; Novo Nordisk Inc.. Consultant; Self; Eli Lilly and Company. Research Support; Self; Dexcom, Inc.. Consultant; Self; Eli Lilly and Company. Advisory Panel; Self; MSD K.K.. Research Support; Self; Pfizer Inc.. Consultant; Self; Medtronic.