Liraglutide versus glimepiride monotherapy for type 2 diabetes (LEAD-3 Mono): a randomised, 52-week, phase III, double-blind, parallel-treatment trial.

Description

The safety and efficacy of liraglutide as compared to glimepiride in the treatment of type 2 diabetes were evaluated in the LEAD-3 Mono study, a randomized, phase III, double-blind, parallel-treatment study. Early type 2 diabetic patients (n=746) were randomly assigned to liraglutide 1.2 mg or 1.8 mg or glimepiride 8 mg for 52 weeks. The decrease in HbA1c with glimepiride was 0.51% compared to 0.84% and 1.14% with liraglutide 1.2 and 1.8 mg, respectively (p=0.0014 for difference between glimepiride and liraglutide 1.2 mg and p<0.0001 for difference between glimepiride and liraglutide 1.8 mg). More patients in both liraglutide groups reached American Diabetes Association (7.0%) or International Diabetes Federation/American Association of Clinical Endocrinologists HbA1c targets (6.5%). Changes (reductions) in body weight were significantly greater with both doses of liraglutide compared to glimepiride, which caused a slight increase in body weight. Five patients in the liraglutide 1.2 mg arm and one patient in the 1.8 mg arm withdrew because of side effects (vomiting). In an editorial accompanying the paper, Madsbad summarized the key results of the LEAD-3 mono study and emphasized that it was the longest study performed with a glucagon-like peptide-1 (GLP-1) analogue. He mentioned that the apparent increased risk of pancreatitis observed with the GLP-1 analogue will have to be investigated. Moreover, he raised the point that although incretin-based therapies offer new options for the treatment of type 2 diabetes, long-term trials with cardiovascular and safety endpoints will have to be conducted to establish their overall contribution to the management of patients with type 2 diabetes.