Liraglutide Effect and Action in Diabetes (LEAD™) trial

Abstract

Liraglutide is the first human glucagon-like peptide-1 receptor analog, based on the structure of native glucagon-like peptide-1 with pharmacokinetic properties suitable for once-daily dosing. In the Phase II studies and the Phase III Liraglutide Effect and Action in Diabetes (LEAD™) program, liraglutide has been shown to lower glycated hemoglobin A1c to the same degree or more than other oral antidiabetic drugs. Liraglutide also induces weight loss and improves β-cell function, blood pressure and some cardiovascular risk markers. Liraglutide is well tolerated; the adverse effect most frequently reported being transient nausea. This article reviews the Phase II studies and the Phase III LEAD™ program. In May 2008, Novo Nordisk submitted a new drug application for liraglutide to the US FDA and the EMEA.

Keywords::

• β-cell function
• GLP-1
• glucagon-like peptide-1 mimetic
• glucagon-like peptide-1 receptor analog
• glycemic control
• Type 2 diabetes
• weight loss

Financial & competing interests disclosure

Sten Madsbad has served as a consultant or adviser to Novartis Pharmaceuticals, Novo Nordisk, Merck, Sharp and Dome, Phizer A/S, Abbott Laboratories, Sanofi Aventis, Astra-Zeneca, Johnson & Johnson, Rosch, Mankind and is a recipient of a research grant from Novo Nordisk. Sten Madsbad has received fee for speaking from Novo Nordisk, Merck, Sharp and Dome, Astra-Zeneca, Johnson and Johnson, Abbott Laboratoires, Phizer A/S, Rosch, Shering-Ploug, Sanofi-Aventis and Novartis Pharmaceuticals. The author has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.