Liraglutide in Paediatric and Adult Subjects with Type 2 Diabetes

• Research type

  Research Study

• Full title

  Liraglutide: A Randomised, Double-blind, Placebo Controlled Trial to Assess Safety/Tolerability, Pharmacokinetics & Pharmacodynamics of Liraglutide in Paediatic (10 - 17 years old) and Adult Subjects with Type 2 Diabetes

• IRAS ID

  61879

• Contact name

  Tim Barrett

• Sponsor organisation

  Novo Nordisk Limited

• Eudract number

  2010-021057-39

• ISRCTN Number

  n/a

• Research summary

  Type 2 diabetes is characterised by insulin resistance, impaired insulin secretion and hyperglycaemia. Optimal glycemic control is the treatment goal in subjects with type 2 diabetes since the risk of long-term complications is associated with poor control. Despite the availability of several oral anti-diabetic drugs and insulin, a significant proportion of subjects with type 2 diabetes do not achieve the recommended target levels.In children, the prevalence of type 2 diabetes has increased considerably during the past decades. Treatment options for children with type 2 diabetes are therefore important. The incidence is significantly higher in age group at or above 10 years of age compared to the age group below 10 years. Therefore, development of antidiabetic treatment is most relevant for children age 10 and above.Glucagon-Like Peptide 1 (GLP-1) is a hormone secreted in the lower gut in response to a meal. It stimulates the production and release of insulin as well as improves the function of the insulin producing cells in pancreas. GLP-1 also slows the passage of food through the gut, resulting in a slower rise in blood glucose after a meal and increasing the sensation of fullness, thereby reducing food intake. Liraglutide, is a modified form of this GLP-1 hormone which is developed and approved for the treatment of type 2 diabetes in adults in the European Union, USA, and Japan under the brand name Victoza.The trial seeks to recruit paediatric subjects with type 2 diabetes who are currently either drug naive (i.e., on diet and exercise) or who are on a stable dose on metformin. Subjects in the trial will either be randomised to active drug or to placebo in a 2:1 manner. Subjects randomised to liraglutide or placebo who were taking metformin prior to entry trial, will remain on metformin throughout the duration of the trial.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  10/H1208/69

• Date of REC Opinion

  11 Nov 2010

• REC opinion

  Further Information Favourable Opinion