Liraglutide, metformin and insulin detemir in type 2 diabetes.

• Research type

  Research Study

• Full title

  The effect of insulin detemir in combination with liraglutide and metformin compared to liraglutide and metformin in subjects with type 2 diabetes. A 26-week, randomised, open-label, parrallel-group, multicentre, multinational trial with a 26-week extension.

• IRAS ID

  10898

• Contact name

  Stephen Bain

• Sponsor organisation

  Novo Nordisk A/S

• Eudract number

  2007-005317-19

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The aim of this study is to investigate the effect of insulin detemir in combination with liraglutide and metformin compared to liraglutide and metformin in subjects with type 2 diabetesBoth liraglutide and insulin detemir are liquids that are administered by an injection under the skin (subcutaneous). Liraglutide and insulin detemir will be provided to patients in injection pens.A planned total of 940 subjects from the following countries will take part in the study: Belgium, Canada, France, Germany, Italy, The Netherlands, Spain, the UK and the US.Subjects will be asked to attend a total of 13 clinic visits and be available for 22 telephone contacts if allocated to the randomised arm or 10 clinic visits in the non randomised arm over a period of 67 weeks. This includes a screening period of 2 weeks a run in period of 12 weeks and a randomised period of 52 weeks.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  08/H0408/214

• Date of REC Opinion

  10 Feb 2009

• REC opinion

  Further Information Favourable Opinion