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81.3%

Cardiovascular outcomes trials (CVOTs) are a robust method to evaluate the safety of drugs, focusing on cardiovascular (CV) outcomes. CVOTs were advised by the US Food and Drug Administration (FDA) in 2008 for all new type 2 diabetes (T2D) treatments.1 In the LEADER trial, Victoza® met the primary objective of showing non-inferiority (no increased CV risk) vs placebo, both on top of standard of care, as well as demonstrating superiority with a statistically signi�cant reduction in cardiovascular risk.2

LEADER was a randomised, double-blind, placebo-controlled CVOT, undertaken to assess the long-term effects of liraglutide on CV outcomes and other clinically important events in adults with T2D and high CV risk.3

Selected secondary endpoints3

• First occurrence of an expanded composite CV outcome of CV death, non-fatal MI, non-fatal stroke, revascularisation, hospitalisation for unstable angina or hospitalisation for heart failure

• Serious adverse events and medical events of special interest

• Time from randomisation to all-cause death

• Time from randomisation to each individual component of the expanded composite CV outcome

• Time from randomisation to individual and composite microvascular outcomes (eye and kidney)

Primary endpoint3 • The time from randomisation to a composite outcome of the �rst occurrence of CV death, non-fatal myocardial infarction (MI), or non-fatal stroke. These endpoint de�nitions follow FDA guidance for major adverse cardiovascular events (MACE)

1. FDA. Guidance for industry diabetes mellitus– evaluating cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes. 2008. Available at: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm071627.pdf Last accessed: February 2016.

2. Novo Nordisk. Company announcement 4 March 2016. Victoza® signi�cantly reduces the risk of major adverse cardiovascular events in the LEADER trial. Available at: https://www.novonordisk.com/bin/getPDF.1991879.pdf Last accessed: May 2016.

3. Marso SP, Poulter NR, Nissen SE, et al. Design of the liraglutide effect and action in diabetes: evaluation of cardiovascular outcome results (LEADER) trial. American Heart Journal. 2013; 166:823–830.

9,340patients

410trial sites

32countries

Followed for

3.5 – 5 years

Prior cardiovasculardisease (CVD)

High CV risk withoutprior CVD 64.3%

men35.7%women

USA2,514 patients

Brazil939 patients

UK453 patients

Germany448 patients

India401 patients

Countries with the highest trialparticipation3

HQMMA/VT/0316/0149Date of approval: May 2016

Internal Use Only

Mean HbA1c

8.7 ± 1.5%

Mean BMI

32.5 ± 6.3 kg/m2

Mean age

64.3 ± 7.2 years