PIONEER 6 – Cardiovascular outcomes

  • Research type

    Research Study

  • Full title

    PIONEER 6: A trial investigating the cardiovascular safety of oral semaglutide in subjects with type 2 diabetes

  • IRAS ID

    203204

  • Contact name

    Stephen Bain

  • Contact email

    s.c.bain@swansea.ac.uk

  • Sponsor organisation

    Novo Nordisk A/S

  • Eudract number

    2015-003563-10

  • Clinicaltrials.gov Identifier

    U1111-1173-0750, UTN number

  • Duration of Study in the UK

    1 years, 6 months, 1 days

  • Research summary

    This trial is a randomised, double-blind, placebo-controlled trial to assess the cardiovascular safety of oral semaglutide versus placebo when added to standard care in subjects with type 2 diabetes and at high risk of cardiovascular events. Subjects will be randomised 1:1 to receive either oral semaglutide or placebo. The trial will be event-driven and will be continued until at least 122 first MACEs (major adverse cardiovascular events) have accrued. The treatment period for each subject is estimated to be between 12 and 19 months, depending on the time-point of recruitment and the time at which the 122 MACE is reached. \n\nThe primary objective is to confirm that treatment with oral semaglutide does not result in an unacceptable increase in cardiovascular risk compared to placebo in subjects with type 2 diabetes at high risk of cardiovascular events.\n\nBlinded treatment with oral semaglutide or placebo offers a robust method for assessment of oral semaglutide’s effect on the trial endpoints. Gradual dose escalation is applied in order to reduce the risk of gastrointestinal adverse events (AEs). Treatment intensification of the background medication is allowed throughout the trial to ensure adequate blood sugar control in all participating subjects. Use of other glucagon-like peptide-1 receptor agonists (GLP-1 RAs) and dipeptidyl peptidase-4 (DPP-4) inhibitors and pramlintide is not allowed, because these drugs, similarly to oral semaglutide, affect the incretin pathway.\n\nThe study will involve around 3176 patients with type 2 diabetes worldwide. It is expected that about 110 of these patients will be from the UK. The trial will require participants to visit their study site 11 times and have a study visit over the telephone on 7 occasions.

  • REC name

    Wales REC 3

  • REC reference

    16/WA/0110

  • Date of REC Opinion

    24 May 2016

  • REC opinion

    Further Information Favourable Opinion