3623 SUSTAIN™ 1 – Monotherapy
Research type
Research Study
Full title
Efficacy and safety of semaglutide once-weekly versus placebo in drug-naïve subjects with type 2 diabetes
IRAS ID
137702
Contact name
Niall Furlong
Contact email
Sponsor organisation
Novo Nordisk A/S
Eudract number
2013-000632-94
Research summary
This study is a 30-weeks randomised, double-blinded, placebo-controlled parallel-group, multi-centre, multinational-four-armed study designed to evaluate the efficacy and safety of semaglutide once-weekly versus placebo in drug-naive subjects with Type 2 diabetes.
The study duration is approximately 37 weeks consisting of a 2 week screening period, a 30 week treatment period and a 5 week follow up period. If eligible, subjects will be randomised in a 2:2:1:1 manner to either semaglutide 1.0mg
semaglutide 0.5mg, placebo 1.0mg or placebo 0.5mg. All medication will be administered once weekly.The study will consist of up to 11 clinic visits and two telephone contact visits.
The study plan is to include a total of 390 randomised subjects across 9 countries including the UK. In the UK,the planned number of randomised subjects is 30 across a possible 3 sites.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
13/NW/0774
Date of REC Opinion
18 Dec 2013
REC opinion
Further Information Favourable Opinion