4216: SUSTAIN-7 semaglutide vs dulaglutide in type 2 diabetes
Research type
Research Study
Full title
Efficacy and safety of semaglutide versus dulaglutide as add-on to metformin in subjects with type 2 diabetes
IRAS ID
189865
Contact name
Adie Viljoen
Contact email
Sponsor organisation
Novo Nordisk A/S
Eudract number
2014-005375-91
Clinicaltrials.gov Identifier
U1111-1164-8495, UTN No.
Duration of Study in the UK
1 years, 4 months, 19 days
Research summary
NN9535-4216 is a randomised, open-label, active-controlled, parallel group, multicentre, multinational, four-armed study comparing the effect of once-weekly subcutaneous dosing of two dose levels of semaglutide versus once-weekly subcutaneous dosing of two dose levels of dulaglutide on glycaemic control in patients with type 2 diabetes treated with metformin.
The study duration is approximately 47 weeks, consisting of a screening period of up to 2 weeks, a 40 week treatment period and a 5 week follow up period. If eligible, participants will be randomised into either one of 2 different doses of weekly semaglutide (0.5mg or 1.0mg) or weekly dulaglutide (0.75mg or 1.5mg). The treatment allocation is in a 1:1:1:1 manner. There will be a 4-weekly dose escalation period on the semaglutide arm starting at 0.25mg until the patient reaches their randomised dose.
The study consists of up to 9 clinic visits and up to 3 telephone visits. The study plan is to include a total of 1196 randomised patients across 17 countries including the UK. In the UK, the planned number of randomised patients is 65 across a possible 9 sites.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
15/EE/0370
Date of REC Opinion
8 Dec 2015
REC opinion
Further Information Favourable Opinion