Date: 2017-06-13
Type of
information: Presentation of results at a congress
phase:
Announcement: presentation of results at the American Diabetes Association 77th Scientific Sessions
Company: Novo Nordisk (Denmark)
Product: Victoza® (liraglutide)
Action
mechanism: Glucagon-like Peptide 1 (GLP-1) analogue. Victoza® is a human glucagon-like peptide-1 (GLP-1) analogue that is 97% similar to endogenous human GLP-1. Like natural GLP-1, Victoza® works by stimulating the beta cells to release insulin and to suppress glucagon secretion from the alpha cells only when blood sugar levels are high. Due to this glucose-dependent mechanism of action, Victoza® is associated with a low rate of hypoglycaemia. The mechanism of blood sugar lowering also involves a delay in gastric emptying.
Disease: type 2 diabetes
Therapeutic
area: Metabolic diseases
Country: Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Mexico, Netherlands, Norway, Poland, Romania, Russian Federation, Serbia, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey, United Arab Emirates, United Kingdom, USA
Trial
details:
- LEADER® (Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results) is a long-term, multicentre, international, randomised, double-blind, placebo-controlled, phase 3b trial having included 9,340 patients to be followed over a five-year period. People with type 2 diabetes were recruited from 32 countries around the world: Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Mexico, Netherlands, Norway, Poland, Romania, Russian Federation, Serbia, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey, United Arab Emirates, United Kingdom, and the United States of America.
- LEADER was initiated in September 2010 and randomised 9,340 people with type 2 diabetes from 32 countries. The primary endpoint was the first occurrence of a composite cardiovascular outcome comprising cardiovascular death, non-fatal myocardial infarction or non-fatal stroke.
- Enrolment concluded in April 2012. An additional 586 patients were recruited beyond the initial target. Of these patients 7,592 (81.3%) already had cardiovascular diseases and 1,748 (18.7%) were at high risk of developing it. At the end of five years, results to be presented in 2016 are expected to describe the CV safety of Victoza® relative to current standard of care.
- An independent Data Monitoring Committee (DMC) is closely observing and assessing the progress of the trial to ensure that it meets the highest standards of ethics and patient safety. The protocol for the LEADER® trial has been designed in close collaboration with an international expert Steering Committee as well as US and EU regulatory authorities, and with assistance from the Population Health Research Institute (PHRI) at McMaster University, Canada.
Latest
news:
- • On June 13, 2017, findings from a post-hoc analysis of the LEADER cardiovascular outcomes trial showed that treatment with Victoza® (liraglutide) resulted in similar reductions in the risk of major cardiovascular events in people with type 2 diabetes at high cardiovascular risk, regardless of whether or not they experienced an episode of severe hypoglycaemia during the trial. Results were presented yesterday at the American Diabetes Association 77th Scientific Sessions.
- For the overall LEADER population, regardless of treatment group, people who experienced a severe hypoglycaemic episode were at a significantly greater risk of major cardiovascular adverse events (cardiovascular death, non-fatal heart attack or non-fatal stroke), cardiovascular-death or non-cardiovascular death. The risk of a cardiovascular event was far greater within 60 days of a severe hypoglycaemic episode occuring.1 At the same time, people treated with Victoza® experienced significantly fewer episodes of severe hypoglycaemia when compared to placebo, both in addition to standard of care.
- • On September 25, 2013, Novo Nordisk has announced that recruitment for the LEADER® (Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results) trial assessing cardiovascular (CV) outcomes of the once-daily GLP-1 analogue, Victoza®, completed in April 2012, resulted in a high-risk population with patient numbers exceeding the original target. The baseline patient characteristics were presented at the Annual Meeting of the European Association for the Study of Diabetes (EASD) in Barcelona, Spain.
Is
general: Yes
