Efficacy & safety of Semaglutide once-weekly versus Exenatide ER 2mg
Research type
Research Study
Full title
Efficacy and safety of semaglutide once-weekly versus exenatide ER 2.0mg once-weekly as add-on to 1-2 oral antidiabetic drugs (OADs) in subjects with type 2 diabetes
IRAS ID
135999
Contact name
Stephen Gough
Contact email
Sponsor organisation
Novo Nordisk A/S
Eudract number
2012-004826-92
Research summary
This study is a randomised, open-label, active-controlled parallel-group, multi-national, multi-centre study designed to evaluate the efficacy and safety of semaglutide 1.0mg once-weekly compared to exenatide ER (extended release) 2.0mg once-weekly in subjects with Type 2 Diabetes.\n\nThe study duration is approximately 63 weeks consisting of a 2 week screening period, a 56 week treatment period and a 5 week follow up period. If eligible, subjects will be randomised in a 1:1 manner to either semaglutide 1.0mg once-weekly or exenatide ER (extended release) 2.0mg once-weekly as an add-on to the 1 or 2 oral antidiabetic (OAD) agents they are current receiving.\n\nThe study will consist of 12 clinic visits and two telephone contact visits. \n\nThe study is planned to include a total of 798 randomised subjects across 12 countries including the UK. In the UK, the planned number of randomised subjects is 50 across a possible 7 sites.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
13/EE/0309
Date of REC Opinion
5 Nov 2013
REC opinion
Further Information Favourable Opinion