NN9535-3744 SUSTAIN 6 Semaglutide Cardiovascular Outcomes Study

• Research type

  Research Study

• Full title

  A long-term, randomised, double-blind, placebo-controlled, multinational, multi-centre trial to evaluate cardiovascular and other long-term outcomes with semaglutide in subjects with type 2 diabetes

• IRAS ID

  114512

• Contact name

  Stephen Bain

• Sponsor organisation

  Novo Nordisk A/S

• Eudract number

  2012-002839-28

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The aim of this study is to confirm the long term effect of semaglutide on cardiovascular outcomes (such as heart attack and stroke) and other clinically important events. The study will also determine the long-term effects of semaglutide on cardiovascular risk factors: blood sugar control, weight, waist circumference, blood lipids and blood pressure. This trial has been designed to address the requirements contained in FDA and European Medicines Agency (EMA) guidance documents "Evaluating Cardiovascular Risk in New Anti-diabetic Therapies to Treat Type 2 Diabetes" and "Guideline on Clinical Investigation of Medicinal Products in the Treatment of Diabetes Mellitus". In this research study, patients are randomised to receive either semaglutide or placebo in addition to standard diabetes care. Both semaglutide and placebo are liquids administered by subcutaneous (under the skin) injection and will be provided to patients in pre-filled injection pens. Approximately 4400 subjects with type 2 diabetes and at high risk of cardiovascular events will participate in this study. Subjects will be be enrolled from over 22 countries in Europe, USA, South and Central America, South Africa, Israel and Asia. In the UK approximately 87 subjects will participate from up to 7 study sites. Overall trial duration from start of screening to end of follow up of the last randomised subject is 150 weeks, a 2 week screening period, a 39 week recruitment period, a 104 week treatment period and a 5 week follow up period. Subjects will attend 17 clinic visits and will have 9 phone call visits, however the exact number of visits will for each subject will depend on timing of randomisation.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  12/SC/0602

• Date of REC Opinion

  18 Dec 2012

• REC opinion

  Further Information Favourable Opinion