3659 Liraglutide in children & adolescents with Type 2 diabetes
Research type
Research Study
Full title
Efficacy and safety of Liraglutide in combination with metformin versus metformin monotherapy on glycaemic control in children and adolescents with type 2 diabetes. A 26-week double-blind, randomised, parallel group, placebo controlled multi-centre trial followed by a 26-week open-label extension.
IRAS ID
104597
Contact name
Timothy Barrett
Sponsor organisation
Novo Nordisk
Eudract number
2011-002605-29
Clinicaltrials.gov Identifier
Research summary
The purpose of the study is to compare the blood sugar lowering effect and safety of liraglutide combined with metformin to that of metformina alone in children and adolescents between 10 - 17 years old with Type 2 diabetes. Trial participants will be randomised to receive either liraglutide or liraglutide placebo (both in combination with metformin treatment) for 14 weeks of treatment. After that, treatment allocation will be unblinded and those subjects receiving liraglutide will remain on it for a further 38weeks of treatment. Those subjects who were on liraglutide placebo will stop this and carry on on metformin alone for 38weeks; however, a second treatment may be added in if needed. Patients will be asked to come to the clinic for 17 visits and have 7 telephone contacts with their study team during a 61 week period. Those patients on liraglutide will then be asked to return for a one year and two year follow up visit. In addition to providing information on their general health, patients will be fully assessed by the study team and have blood samples taken. They will be asked to complete study diaries and to perform self-monitoring of their blood glucose levels. The study is being carried out in agreement with the European Paediatric Committee (PDCO) as part of the Paediatric Investigational Plan (PIP).
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
12/WM/0149
Date of REC Opinion
6 Jun 2012
REC opinion
Favourable Opinion