AIMS: Effects of the long acting GLP-1 analogue--liraglutide in subjects with type 2 diabetes. METHODS: 144 type 2 diabetic subjects onmetformin treatment (1000 mg BID) were randomised to 5 weeks of treatment (double-blind) with metformin plus liraglutide, liraglutide or metformin, or metformin plus glimepiride (open label). The dose of liraglutide was increased weekly from 0.5 to 2 mg OD. RESULTS:Liraglutide added to metformin monotherapy was associated with a significant reduction in fasting serum glucose (FSG) (-3.9 mM -4.9; -2.9) (primary objective), and HbA1c levels (-0.8% -1.2; -0.4). Furthermore, liraglutide in combination with metformin vs. metformin plus glimepiride significantly reduced FSG (-1.2 mM -2.2; -0.2). In addition, body weight was significantly lower in the metformin plus liraglutide vs. the metformin plus glimepiride group (-2.9 kg -3.6; -2.1). There were no biochemically confirmed episodes of hypoglycaemia with liraglutide treatment. Nausea was the most frequently reported adverse event following liraglutide therapy, it was transient in nature, and led to withdrawal of only 4% of the subjects. CONCLUSIONS: Using a weekly dose-titration liraglutide is well tolerated up to 2 mg daily. While liraglutide caused transient gastrointestinal side effects, this rarely interfered with continuing treatment. An improvement in FSG over that in control groups was seen for liraglutide as an add-on to metformin. In the latter case, body weight was reduced in comparison to metformin plus glimepiride. Liraglutide is a promising drug for the treatment of type 2 diabetes.
RCT Entities:
AIMS: Effects of the long acting GLP-1 analogue--liraglutide in subjects with type 2 diabetes. METHODS: 144 type 2 diabetic subjects on metformin treatment (1000 mg BID) were randomised to 5 weeks of treatment (double-blind) with metformin plus liraglutide, liraglutide or metformin, or metformin plus glimepiride (open label). The dose of liraglutide was increased weekly from 0.5 to 2 mg OD. RESULTS: Liraglutide added to metformin monotherapy was associated with a significant reduction in fasting serum glucose (FSG) (-3.9 mM -4.9; -2.9) (primary objective), and HbA1c levels (-0.8% -1.2; -0.4). Furthermore, liraglutide in combination with metformin vs. metformin plus glimepiride significantly reduced FSG (-1.2 mM -2.2; -0.2). In addition, body weight was significantly lower in the metformin plus liraglutide vs. the metformin plus glimepiride group (-2.9 kg -3.6; -2.1). There were no biochemically confirmed episodes of hypoglycaemia with liraglutide treatment. Nausea was the most frequently reported adverse event following liraglutide therapy, it was transient in nature, and led to withdrawal of only 4% of the subjects. CONCLUSIONS: Using a weekly dose-titration liraglutide is well tolerated up to 2 mg daily. While liraglutide caused transient gastrointestinal side effects, this rarely interfered with continuing treatment. An improvement in FSG over that in control groups was seen for liraglutide as an add-on to metformin. In the latter case, body weight was reduced in comparison to metformin plus glimepiride. Liraglutide is a promising drug for the treatment of type 2 diabetes.