4339: SUSTAIN 10 Semaglutide versus Liraglutide in Type 2 Diabetes
Research type
Research Study
Full title
SUSTAIN 10: Efficacy and safety of semaglutide 1.0mg once-weekly versus liraglutide 1.2mg once-daily as add-on to 1-3 oral anti-diabetic drugs (OADs) in subjects with type 2 diabetes.
IRAS ID
225662
Contact name
Matthew Capehorn
Contact email
Sponsor organisation
Novo Nordisk Ltd
Eudract number
2016-004965-22
Clinicaltrials.gov Identifier
U1111-1190-5868, UTN
Duration of Study in the UK
1 years, 1 months, 18 days
Research summary
The current treatments for type 2 diabetes (T2D) are still not satisfactory, as a large proportion of patients do not reach their treatment targets for blood sugar control. Furthermore, there is a segment of patients, who either have difficulties adhering to once-daily treatments, or have a wish for more convenient treatment regimens such as once-weekly treatments.
Semaglutide and Liraglutide (Victoza®) are similar to a hormone (GLP-1) in the body that helps to reduce blood sugar. Semaglutide is given as a once weekly subcutaneous (under the skin) injection, liraglutide is given as a once daily subcutaneous injection. Semaglutide is expected to be marketed with two treatment doses (0.5 mg and 1.0 mg). Dose-dependent reductions in both HbA1c (marker of blood sugar) and body weight were observed in prior clinical trials with significantly more patient reaching treatment targets with semaglutide 1.0 mg compared to semaglutide 0.5 mg. Hence, 1.0 mg is expected to be the most frequently used dose when semaglutide is marketed. For liraglutide, the 1.2 mg dose of Victoza® is the most commonly used dose in most European countries. Therefore, the aim for the current trial is to study the efficacy and safety of once-weekly 1.0 mg semaglutide versus once-daily 1.2 mg liraglutide in patients with T2D that are eligible for treatment intensification.
Study duration is 37 weeks: a 2 week screening period, a 30 week treatment period and a 5 week follow-up period. If eligible, participants will be randomised to either the semaglutide or the liraglutide treatment group. The study consists of 7 clinic visits and 3 telephone visits.
The study plans to include 576 participants across 10 countries. In the UK the planned number of participants is 150 across 18 sites.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
17/YH/0116
Date of REC Opinion
24 May 2017
REC opinion
Further Information Favourable Opinion