Liraglutide, a long-acting human glucagon-like peptide-1 analog, given as monotherapy significantly improves glycemic control and lowers body weight without risk of hypoglycemia in patients with type 2 diabetes.

摘要

Liraglutide is a long-acting human glucagon-likepeptide-1 (GLP-1) an-alog (1-4), and the current study was undertaken to evaluate efficacy and safety after 14 weeks' treatment with lira-glutide in patients with type 2 diabetes. RESEARCH DESIGN AND METHODS ?Main inclusion criteria were patients aged >=18 years with type 2 diabetes and A1C >=7.5 and <=10.0% (diet) or >=7.0 and <=9.5% (mono-oral antidiabetes drug); previous therapy was discontinued. Fasting plasma glucose (FPG) at randomization was 7-13 mmol/l. If FPG was >15 mmol>l during the study, the patient was withdrawn. The study was conducted in accordance with the Declaration of Helsinki (5). The study was double-blind, randomized (1:1:1:1), and placebo-controlled using three doses of liraglutide (0.65, 1.25, or 1.90 mg). The following main efficacy parameters were assessed; A1C, insulin, proinsulin, glucagon, fructosamine, lipids, home-measured seven-point plasma glucose profiles, and body weight. Safety param-eters (adverse events, hypoglycemicepi-sodes, clinical laboratory parameters, antibodies against liraglutide, vital signs, electrocardiogram, and thyroid (includ-ing ultrasonography) and parathyroid pa-rameters were assessed. Liraglutide or placebo was administered in the evening (as in the most recently completed phase 2 study) (6) as once-daily subcutaneous injections in the abdomen or thigh.