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

Authors

Tina Vilsbøll•Milan Zdravkovic•Sten Madsbad

Published

May 25, 2007

Abstract

iraglutide is a long-acting human glucagon-like peptide-1 (GLP-1) analog (1-4), and the current study was undertaken to evaluate efficacy and safety after 14 weeks' treatment with liraglutide in patients with type 2 diabetes. RESEARCH DESIGN AND METHODS -Main inclusion criteriawere patients aged Ն18 years with type 2 diabetes and A1C Ն7.5 and Յ10.0% (diet) or Ն7.0 and Յ9.5% (mono-oral antidiabetes drug); previous therapy was discontinued.Fasting plasma glucose (FPG) at randomization was 7-13 mmol/l.If FPG was Ͼ15 mmol/l during the study, the patient was withdrawn.The study was conducted in accordance with the Declaration of Helsinki (5).The study was double-blind, randomized (1:1:1:1), and placebo-controlled using three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, homemeasured seven-point plasma glucose profiles, and body weight.Safety parameters (adverse events, hypoglycemic episodes, clinical laboratory parameters, antibodies against liraglutide, vital signs, electrocardiogram, and thyroid (including ultrasonography) and parathyroid parameters 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.