Comparison of efficacy and safety of liraglutide and glimepiride in combination with metformin in type 2 diabetes

Abstract

Objective To investigate the efficacy and safety of liraglutide added to metformin in Chinese patients with type 2 diabetes mellitus. Methods This 16-week, randomized, double-blind, double-dummy trial was conducted from February 2008 to January 2009. The 476 subjects were randomized to receive either liraglutide (0.6, 1.2 or 1.8 mg once daily) or glimepiride (4 mg once daily), both combined with metformin (1 g twice daily). The primary endpoint was change in HbA1c. The secondary endpoints included body weight, fasting blood glucose, systolic blood pressure (SBP), etc . The efficacy endpoints were analysed by using analysis of covariance model. Results A total of 476 subjects (246 males and 230 females) with a mean age of (54±9) years, a mean HbA1c of 8.3%±1.1%, a mean body mass index(BMI) of (25±3) kg/m2 and a mean duration of diabetes of 6.9 years, were included in this trial. The demographic and clinical data were comparable among the treatment groups. Substantial reductions in HbA1c from baseline were observed for both liraglutide (1.1%-1.2%) and glimepiride (1.3%) group. Both liraglutide 1.2 and 1.8 mg treatments was non-inferior to glimepiride in term of HbA1c reduction (95% CI: -0.15-0.31, P<0.01; 95%CI: -0.13-0.33, P<0.01, respectively). Liraglutide led to significantly greater reduction in body weight (1.1-1.8 kg) and SBP (1.8-2.6 mm Hg, 1 mm Hg=0.133 kPa) compared to glimepiride group (with an increase of 0.6 kg in body weight and 2.1 mm Hg in SBP, all P<0.05). All the liraglutide treatment groups showed lower risk of hypoglycemia in comparison with glimepiride group (0.03, 0, 0.10 and 1.47 times/person-year, respectively; all P<0.01). Conclusion Liraglutide is well tolerated and brings similar improvements in glycemic control with glimepiride and with additional benefits in body weight loss and SBP reduction and a lower risk of hypoglycemia in Chinese subjects with type 2 diabetes. Key words: Diabetes mellitus, type 2; Liraglutide; Glucagon-like peptide-1