Empagliflozin (EMPA), a selective SGLT2 inhibitor, as add-on to basal insulin for 78 weeks improves Glycemic control with weight loss in insulin-treated Type 2 Diabetes (T2DM)

Background, methods: We assessed EMPA as add-on to basal insulin in patients with T2DM (n = 494; mean HbA1c 8.2%; BMI 32.2 kg/m2) randomized to double-blind EMPA 10 mg or 25 mg or placebo (PBO) qd for 78 weeks. Basal insulin dose remained constant for the first 18 weeks, then adjusted to meet glucose targets. Primary endpoint was change from baseline in HbA1c at week 18. Key secondary endpoints were changes from baseline in insulin dose and HbA1c at week 78. Results: Adjusted mean changes from baseline in HbA1c at week 18 were -0.01% with PBO versus -0.57% and -0.71% with EMPA 10 mg and 25 mg, and at week 78 wer…