Denmark’s Novo Nordisk, the world’s biggest maker of insulin, on Friday said it expected to start a Phase III trial for its drug candidate liraglutide in obesity before the end of this year.
Novo has already filed for regulatory approval in major markets for the drug as a treatment of type 2 diabetes.
Novo said ahead of a capital markets presentation day on Friday that the liraglutide study would include 4,500-5,000 patients.
One-year data from the study is expected in early 2011, Novo said.
Liraglutide is part of a class known as incretin mimetics designed to induce the same effects as a blood sugar-improving hormone called GLP-1.
GLP-1 class drugs stimulate the release of insulin only when glucose levels become too high. They also lead to weight loss, which is seen as an advantage over other types of diabetes medicines, because obesity is a leading cause of the disease.
Novo said the liraglutide Phase III study will investigate weight management in obese patients, but also explore a potential delay in onset of diabetes, weight management in type 2 diabetes as well as prevention of weight regain.
DID YOU KNOW:
Undiagnosed Diabetes Estimates Rise To 7 Million: The number of estimated cases of undiagnosed diabetes in the US has risen to 7 million, sparking a need for greater public awareness of the condition and its symptoms to aid early diagnosis. The number of estimated cases of undiagnosed diabetes in the US has risen to 7 million, prompting calls for greater investment in public awareness campaigns as to the causes and symptoms of the condition. More has to be done to increase awareness and educate the general public about diabetes and how to live with it once diagnosed.
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