4191: Once Daily Semaglutide Dose Finding in Type 2 DM
Research type
Research Study
Full title
Dose-finding of semaglutide administered subcutaneously once daily versus placebo and liraglutide in subjects with type 2 diabetes. A 26-week, multicentre, double-blind, randomised, controlled dose-finding trial
IRAS ID
183369
Contact name
Rustam Rea
Contact email
Sponsor organisation
Novo Nordisk A/S
Eudract number
2014-003196-39
Duration of Study in the UK
1 years, 0 months, 27 days
Research summary
NN9535-4191 is a 26-week multicentre, randomised, double-blind , dose–finding study comparing semaglutide administered subcutaneously once daily to placebo and liraglutide in patients diagnosed with Type 2 diabetes treated with diet and exercise with or without metformin.
The study duration is approximately 35 weeks, consisting of a 2 week screening period, a 26 week treatment period and a 7 week follow-up period. If eligible, participants will be randomised to either the blinded treatment group (12 out of 13 chance) or to the open label semaglutide group (1 out of 13 chance). If randomised to the blinded treatment group the treatment allocation is made in a 2:2:1 manner to either semaglutide, liraglutide or placebo. The blinded treatment groups will escalate their dose every 4 weeks until their final randomised dose level is reached. The open label treatment group will have a more flexible dose escalation based on tolerability.
The study consists of a maximum of 13 clinic visits and 3-4 telephone contact visits.
The study plan is to include a total of 704 randomised participants across 10 countries including the UK. In the UK the planned number of participants is 75 across 13 sites.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
15/SC/0380
Date of REC Opinion
22 Jul 2015
REC opinion
Further Information Favourable Opinion