LEADER, liraglutide cardiovascular outcome study in type 2 diabetes

• Research type

  Research Study

• Full title

  LEADER- Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results. A long-term, multi-centre, international, randomised, double-blind, placebo-controlled trial to determine liraglutide effects in cardiovascular events.

• IRAS ID

  55988

• Contact name

  Stephen Bain

• Sponsor organisation

  Novo Noridsk A/S

• Eudract number

  2009-012201-19

• ISRCTN Number

  N/A

• Research summary

  The aim of this study is to confirm the long term effect of liraglutide on cardiovascular outcomes (such as heart attack and stroke) and other clinically important events. The study will also determine the long-term effects of liraglutide on cardiovascular risk factors: blood sugar control, weight, waist circumference, blood lipids and blood pressure. Liraglutide is marketed in the UK under the name of Victoza© for the treatment of Type 2 diabetes. The study is a post-approval commitment study for both the EMA and FDA. In this research study, patients are randomised to receive either liraglutide in addition to standard diabetes care or placebo in addition to standard diabetes care. Both liraglutide and placebo are liquids administered by subcutaneous (under the skin) injection and will be provided to patients in injection pens. Approximately 9000 subjects with type 2 diabetes and at high risk of cardiovascular events will participate in this study. Subjects will be enrolled from over 30 countries in Europe, USA, South and Central America, South Africa, Israel, United Arab Emirates and Asia. In the UK approximately 400 subjects will participate from up to 26 study sites. Depending on when a subject enters the study they will receive study medication and be followed up for between 3.5 and 5 years and attend between 12 and 15 clinic visits. This includes 7 visits in the first year and 2 visits a year for the subsequent years. In addition, between these visits subjects will collect study medication: between 5 to 7 visits depending on study enrolment date. If on these occasions the subjects do not see the investigational study staff they will be contacted by 'phone to check on their well-being. A follow-up visit will be performed for subjects with a raised calcitonin level.

• REC name

  West Midlands - Coventry & Warwickshire Research Ethics Committee

• REC reference

  10/H1211/20

• Date of REC Opinion

  13 Jul 2010

• REC opinion

  Favourable Opinion