SUSTAIN 8 NN9535-4270
Research type
Research Study
Full title
NN9535-4270, SUSTAIN 8 – semaglutide versus canagliflozin, Efficacy and safety of semaglutide versus canagliflozin as add-on to metformin in subjects with type 2 diabetes
IRAS ID
218702
Contact name
Rory McCrimmon
Contact email
Sponsor organisation
Novo Nordisk
Eudract number
2016-000989-35
Clinicaltrials.gov Identifier
U1111-1180-3651 , UTN number
Duration of Study in the UK
1 years, 7 months, 10 days
Research summary
This trial has been designed as a double-blind, two-arm, parallel-group trial to compare the effect of semaglutide s.c. 1.0 mg once-weekly versus canagliflozin 300 mg once-daily, as add-on to metformin, in terms of glycaemic control, weight management and other effect parameters. The trial is designed to address and compare safety, tolerability, patient well-being and treatment satisfaction. Body composition will be measured using dual energy x-ray absorptiometry (DXA) in a subset of 174 subjects (87 subjects per treatment arm) at V1 and V10 or V10A.
Subjects with type 2 diabetes inadequately controlled with metformin alone will be randomised in a 1:1 manner to receive either 1.0 mg semaglutide once-weekly or 300 mg canagliflozin once-daily.
The primary objective is to compare the effect of once-weekly (OW) dosing of subcutaneous semaglutide (1.0 mg) versus once-daily dosing of oral canagliflozin (300 mg) on glycaemic control in subjects with type 2 diabetes (T2D) on a background treatment of metformin.
Semaglutide is administered as s.c. injections and canagliflozin as oral tablets. In order to fulfil blinding, a double-dummy design has been implemented. Accordingly, all subjects randomised to semaglutide s.c. will also receive canagliflozin placebo tablets, while subjects randomised to canagliflozin will also receive semaglutide placebo s.c. injections. The treatment duration of 52 weeks is considered adequate for assessment of effect, safety, tolerability and patient satisfaction. The follow-up period is 5 weeks to allow for wash-out of semaglutide.
Canagliflozin has been chosen as comparator since it is an established and currently the market leading OAD within the class of SGLT-2 inhibitors and treatment will be initiated with 100 mg and escalated to the highest maintenance dose of 300 mg once-daily.
A planned total number of 784 subjects will be randomised globally with approx 110 from the UK. There will be 9 site visits and 2 telephone visits.
REC name
London - Fulham Research Ethics Committee
REC reference
16/LO/2110
Date of REC Opinion
20 Dec 2016
REC opinion
Favourable Opinion