Cookies on this website

We use cookies to ensure that we give you the best experience on our website. If you click 'Accept all cookies' we'll assume that you are happy to receive all cookies and you won't see this message again. If you click 'Reject all non-essential cookies' only necessary cookies providing core functionality such as security, network management, and accessibility will be enabled. Click 'Find out more' for information on how to change your cookie settings.

Aims: To investigate efficacy and safety of dual therapy with liraglutide and metformin in comparison to glimepiride and metformin, and metformin monotherapy over 2years 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 1.8mg once-daily), placebo or glimepiride; all with metformin. Patients were enrolled if they were 18-80years old with HbA1c 7.0-11.0% (previous monotherapy ≥3months), or 7.0-10.0% (previous combination therapy ≥3months), and body mass index ≤40kg/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 0.6mg, 0.6% with 1.2 and 1.8mg) versus 0.3% increase with metformin monotherapy (p<0.0001). HbA1c decrease with liraglutide was non-inferior versus 0.5% decrease with glimepiride. Liraglutide groups experienced significant weight loss (2.1, 3.0 and 2.9kg with 0.6, 1.2 and 1.8mg, respectively) compared to weight gain (0.7kg) with glimepiride (p<0.0001). Weight loss with liraglutide 1.2 and 1.8mg was significantly greater than with metformin monotherapy (1.8kg; p=0.0185 and p=0.0378 for 1.2 and 1.8mg, respectively). The occurrence of minor hypoglycaemia was <5.0% in all liraglutide groups, significantly less than with glimepiride (24.0%; p<0.0001). Liraglutide was well tolerated overall: gastrointestinal events were more common than with glimepiride or metformin monotherapy, but occurrence decreased with time. Conclusions: Liraglutide provided sustained glycaemic control over 2 years comparable to that provided by glimepiride. Liraglutide was well tolerated, and was associated with weight loss and a low rate of hypoglycaemia. © 2012 Blackwell Publishing Ltd.

Original publication




Journal article


Diabetes, Obesity and Metabolism

Publication Date





204 - 212