ELIOT (Effect of Liraglutide in Obesity Treatment) - Diabetes

• Research type

  Research Study

• Full title

  Effect of liraglutide on body weight in overweight or obese subjects with type 2 diabetes. A 1 year randomised, double-blind, placebo-controlled, three armed parallel group, multi-centre, multinational trial with a 12 week observational follow-up period.

• IRAS ID

  5751

• Contact name

  Nick Finer

• Sponsor organisation

  Novo Nordisk A/S

• Eudract number

  2008-002199-88

• ISRCTN Number

  n.a

• Clinicaltrials.gov Identifier

  n.a

• Research summary

  The aim of this study is to investigate the effect of liraglutide on weight loss in overweight or obese subjects with type 2 diabetes. Liraglutide is a modified form of a naturally-occurring hormone called GLP-1 (glucagon-like peptide 1). GLP-1 is produced in the gut after eating a meal and has several effects on the body, one of which is to slow down the passage of food through the gut leading to an increased feeling of fullness. Liraglutide has similar effects to GLP-1 and has been shown to cause weight loss in previous studies. Subjects included in the study will have a 75% (3 in 4) chance of receiving liraglutide at one of two doses (3mg or 1.8mg), with 25% (1 in 4) receiving placebo. To avoid bias, neither the study doctor nor the subject will know which treatment the subject is receiving (double-blind). Liraglutide is a liquid which is administered by an injection under the skin (subcutaneous). It will be provided to patients in an injection pen (FlexPen©). Subjects will also be asked to go onto a calorie controlled diet and will be given dietary and lifestyle counselling throughout the study. A planned total of 800 subjects from the following countries will take part in the study: France, Germany, India, Israel, Italy, South Africa, Spain, Sweden, Taiwan, Turkey, United Kingdom and USA. Subjects will be asked to attend a total of 21 visits over a period of 66 weeks. This will include a screening period of 2 weeks, a treatment period of 52 weeks and a follow-up period of 12 weeks.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  08/H0304/110

• Date of REC Opinion

  4 Nov 2008

• REC opinion

  Favourable Opinion