3623 SUSTAIN™ 1 – Monotherapy

• Research type

  Research Study

• Full title

  Efficacy and safety of semaglutide once-weekly versus placebo in drug-naïve subjects with type 2 diabetes

• IRAS ID

  137702

• Contact name

  Niall Furlong

• Contact email

  niall.furlong@sthk.nhs.uk

• Sponsor organisation

  Novo Nordisk A/S

• Eudract number

  2013-000632-94

• Research summary

  This study is a 30-weeks randomised, double-blinded, placebo-controlled parallel-group, multi-centre, multinational-four-armed study designed to evaluate the efficacy and safety of semaglutide once-weekly versus placebo in drug-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 2:2:1:1 manner to either semaglutide 1.0mg
  semaglutide 0.5mg, placebo 1.0mg or placebo 0.5mg. All medication will be administered once weekly.

  The study will consist of up to 11 clinic visits and two telephone contact visits.

  The study plan is to include a total of 390 randomised subjects across 9 countries including the UK. In the UK,the planned number of randomised subjects is 30 across a possible 3 sites.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  13/NW/0774

• Date of REC Opinion

  18 Dec 2013

• REC opinion

  Further Information Favourable Opinion