Empagliflozin as add‐on to metformin in people with Type 2 diabetes

Aims To investigate the long‐term efficacy and safety of empagliflozin as add‐on to metformin in people with Type 2 diabetes. Methods Of 637 participants treated with empagliflozin 10 mg, empagliflozin 25 mg, or placebo once daily for 24 weeks, 463 (72.7%) were treated in a double‐blind extension trial for ≥ 52 weeks. Prespecified exploratory endpoints included changes from baseline in HbA 1c , weight and blood pressure at week 76. Results Compared with placebo, adjusted mean changes from baseline in HbA 1c (overall baseline mean ±  sd 63 ± 9 mmol/mol [7.9 ± 0.9%]) were −7 mmol/mol [(−0.6%) 95% CI −8, −5 mmol/mol (−0.8, −0.5%); P  <   0.001] and −8 mmol/mol [(−0.7%) 95% CI −10, −6 mmol/mol (−0.9, −0.6%); P  <   0.001], for empagliflozin 10 mg and 25 mg, respectively. Compared with placebo, adjusted mean changes from baseline in weight were −1.9 kg (95% CI −2.5, −1.3; P  <   0.001) and −2.2 kg (95% CI −2.8, −1.6; P  <   0.001) for empagliflozin 10 mg and 25 mg, respectively. Empagliflozin led to sustained reductions in systolic blood pressure vs. placebo. Adverse events were reported in 77.7, 80.2 and 72.0% of participants on placebo, empagliflozin 10 mg and empagliflozin 25 mg, respectively. Confirmed hypoglycaemic adverse events (glucose ≤ 3.9 mmol/l and/or event requiring assistance) were reported in 3.4, 4.1 and 4.2% of participants in these groups, respectively. Conclusions In people with Type 2 diabetes, empagliflozin 10 mg and 25 mg given as add‐on to metformin for 76 weeks were well tolerated and led to sustained reductions in HbA 1c , weight and systolic blood pressure.