3625 SUSTAIN™4 Semaglutide vs. Basal Insulin in Type 2 Diabetes
Research type
Research Study
Full title
Efficacy and safety of semaglutide once weekly versus insulin glargine once daily as add on to metformin with or without sulphonylurea in insulin-naive subjects with type 2 diabetes
IRAS ID
152207
Contact name
Robert Andrews
Contact email
Sponsor organisation
Novo Nordisk A/S
Eudract number
2013-004392-12
Research summary
This study is a 30-week randomised, open-label, active-controlled, parallel-group, multi-centre, multinational, three-armed study comparing two doses of semaglutide (0.5mg and 1.0mg) once-weekly versus insulin glargine once-daily in insulin-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 1:1:1 manner to either semaglutide 0.5mg, semaglutide 1.0mg or insulin glargine treat to target. Semaglutide treatment will be administered once weekly and insulin glargine administered once daily.
The study consists of up to 9 clinic visits and 8 telephone contact visits.
The study plan is to include a total of 1047 randomised subjects across 13 countries including the UK. In the UK, the planned number of randomised subjects is 90 across a possible 14 sites.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
14/SC/0234
Date of REC Opinion
17 Jun 2014
REC opinion
Further Information Favourable Opinion