Empagliflozin as add-on to metformin plus sulfonylurea in patients with type 2 diabetes
Abstract
Aim: To assess long-term safety and efficacy of empagliflozin as add-on to metformin plus sulphonylurea versus placebo in patients with type 2 diabetes. Methods: Of 666 patients treated with empagliflozin 10 mg, empagliflozin 25 mg or placebo in a 24-week study (EMPA-REG METSU TM ), 71.2% continued in a Phase III double-blind extension trial (EMPA-REG EXTEND™ METSU) for ≥52 weeks (until the last person had been treated for 76 weeks). Exploratory efficacy endpoints were changes from baseline (of EMPA-REG METSU TM ) in HbA1c and body weight at week 76. Results: At baseline, mean HbA1c (%) was 8.15, 8.07, 8.10 and mean weight (kg) was 76.2, 77.1, 77.5 in the placebo, empagliflozin 10 mg and empagliflozin 25 mg groups, respectively. Compared with placebo, adjusted mean (95% CI) changes from baseline in HbA1c at week 76 were -0.72% (-0.87, -0.56) with empagliflozin 10 mg and -0.69% (-0.85, -0.53) with empagliflozin 25 mg (both p < 0.001), and in weight were -1.8 kg (-2.3, -1.3) with empagliflozin 10 mg and -1.6 kg (-2.2, -1.1) with empagliflozin 25 mg (both p < 0.001). Adverse events (AEs) were reported in 81.3%, 81.7% and 82.0% of patients on placebo, empagliflozin 10 mg and empagliflozin 25 mg, respectively. Hypoglycaemic AEs (glucose ≤3.9 mmol/l and/or requiring assistance) were reported in 15.6%, 23.7% and 19.4% of patients on placebo, empagliflozin 10 mg and 25 mg, respectively; 1 patient each on placebo and empagliflozin 10 mg required assistance. Conclusion: Empagliflozin…
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