NN9068-3697 IDegLira, Degludec and Liraglutide in Type 2 Diabetes

• Research type

  Research Study

• Full title

  A 26 week randomised, parallel three-arm, open-label, multi-centre, multinational treat-to-target trial comparing fixed ratio combination of insulin degludec and liraglutide versus insulin degludec or liraglutide alone, in subjects with type 2 diabetes treated with 1-2 oral anti-diabetic drugs (OADs)

• IRAS ID

  68693

• Contact name

  Stephen Gough

• Sponsor organisation

  Novo Noridsk A/S

• Eudract number

  2010-021560-15

• ISRCTN Number

  n/a

• Research summary

  Insulin degludec/liraglutide is a fixed ratio combination of insulin degludec and liraglutide developed for subjects with type 2 diabetes as add-on to OADs. Current anti-diabetic therapies do not provide sustained glycaemic control and may lead to an unacceptable risk of hypoglycaemia and weight gain. Additionally, therapies are often complicated and difficult for subjects.According to regulatory guidelines the benefit/risk assessment of a fixed combination must be equal to, or exceed that of each of the individual components. The aim of this trial is to comply with this guideline, and in addition establish clinical proof of concept for treatment with insulin degludec/liraglutide in subjects with type 2 diabetes. Therefore, the trial is designed to demonstrate non-inferiority (with regard to glycaemic control) for insulin degludec/liraglutide compared to the separate components (insulin degludec and liraglutide), as well as superiority over each individual component on specified secondary endpoints. Insulin degludec/liraglutide, insulin degludec and liraglutide are liquids that are administered under the skin and will be provided to subjects in injection pens. It is planned that 1660 patients will be randomised globally from the following list of participating countries: Australia, Canada, Finland, France, Germany, Hungary, India, Ireland, Italy, Malaysia, Mexico, Russia, Singapore, Slovakia, South Africa, Spain, Taiwan, Thailand, United Kingdom and US. Participating subjects will be randomised to 1 of 3 treatment arms (insulin degludec/liraglutide once daily, insulin degludec once daily or liraglutide once daily). They will continue on a stable unchanged dose of metformin or metformin pioglitazone throughout the trial. The duration of the trial from screening to follow-up will be approximately 29 weeks with a treatment duration of 26 weeks. Subjects will be asked to attend a total of 11 clinic visits and to be available for 18 telephone contacts. Sub Study: 256 subjects will undergo 72-hour interstitial glucose levels with a CGM device and perform a meal test.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  11/H0715/11

• Date of REC Opinion

  22 Mar 2011

• REC opinion

  Further Information Favourable Opinion