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 HbA1c, weight and blood pressure at week 76. Results Compared with placebo, adjusted mean changes from baseline in HbA1c (overall baseline mean ± sd 63 ± 9 mmol/mol [7.9 ± 0.9%]) were â'7 mmol/mol [(â'0.6%) 95% CI â'8, â'5 mmol/mol (â'0.8, â'0.5%); P < 0.001] and â'8 mmol/mol [(â'0.7%) 95% CI â'10, â'6 mmol/mol (â'0.9, â'0.6%); P < 0.001], for empagliflozin 10 mg and 25 mg, respectively. Compared with placebo, adjusted mean changes from baseline in weight were â'1.9 kg (95% CI â'2.5, â'1.3; P < 0.001) and â'2.2 kg (95% CI â'2.8, â'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 HbA1c, weight and systolic blood pressure. [ABSTRACT FROM AUTHOR]