Long-term efficacy and safety comparison of liraglutide, glimepiride and placebo, all in combination with metformin in type 2 diabetes: 2-year results from the LEAD-2 study

Aims To investigate efficacy and safety of dual therapy with liraglutide and metformin in comparison to glimepiride and metformin, and metformin monotherapy over 2?years in patients with type 2 diabetes. Methods In the 26-week the Liraglutide Effect and Action in Diabetes (LEAD)-2 core trial, patients (n?=?1091) were randomized (2?:?2?:?2?:?1:?2) to liraglutide (0.6, 1.2 or 1.8?mg once-daily), placebo or glimepiride; all with metformin. Patients were enrolled if they were 1880?years old with HbA1c 7.011.0% (previous monotherapy =3?months), or 7.010.0% (previous combination therapy =3?months), and body mass index =40?kg/m2. Patients completing the 26-week double-blinded phase could enter an 18-month open-label extension. Results HbA1c decreased significantly with liraglutide (0.4% with 0.6?mg, 0.6% with 1.2 and 1.8?mg) versus 0.3% increase with metformin monotherapy (p?