ODYSSEY DM - DYSLIPIDEMIA

• Research type

  Research Study

• Full title

  A Randomized, Open-Label, Parallel Group Study to Evaluate the Efficacy and Safety of Alirocumab Versus Usual Care in Patients with Type 2 Diabetes and Mixed Dyslipidemia at High Cardiovascular Risk with Non-HDL-C Not Adequately Controlled with Maximally Tolerated Statin Therapy

• IRAS ID

  198056

• Contact name

  Adie Viljoen

• Contact email

  adie.viljoen@nhs.net

• Sponsor organisation

  Sanofi-Aventis Groupe

• Eudract number

  2015-001934-19

• Duration of Study in the UK

  1 years, 1 months, 4 days

• Research summary

  This study is to demonstrate the superiority of alirocumab in comparison with
  usual care in the reduction of non-high-density lipoprotein cholesterol (non-HDL-C) after 24 weeks of treatment in patients with Type 2 diabetes and mixed dyslipidemia at high cardiovascular (CV) risk with non-HDL-C not adequately controlled with maximally tolerated statin therapy.

  Patients will be randomised to receive either alirocumab (75mg administered via an auto-injector every 2 weeks for 6 months) or usual care in a 2:1 ratio. Patients randomised to alirocumab , but not achieving adequate lowering in LDL-cholesterol will have their dosage increased to 150mg after 3 months of treatment, in a blinded manner.

  The study consists of a 1-3 weeks of screening period, followed by a 24 week treatment period (5 onsite visits, 1 phone call), and a safety follow up period of 8 weeks (1 phone call).

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  16/NW/0147

• Date of REC Opinion

  12 Apr 2016

• REC opinion

  Further Information Favourable Opinion