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

Trial Profile

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

Completed
Phase of Trial: Phase IV

Latest Information Update: 01 Sep 2017

At a glance

  • Drugs Alirocumab (Primary) ; Ezetimibe; Fenofibrate; HMG-CoA reductase inhibitors; Nicotinic-acids; Omega 3 fatty acids
  • Indications Dyslipidaemias
  • Focus Therapeutic Use
  • Acronyms ODYSSEY DM-Dyslipidemia
  • Sponsors Sanofi
  • Most Recent Events

    • 21 Jun 2017 Status changed from active, no longer recruiting to completed.
    • 11 Jun 2017 Primary endpoint has been met (Percent change in non-HDL-C in the intent-to-treat (ITT) population), according to a Regeneron Pharmaceuticals media release.
    • 11 Jun 2017 Results published in the American Diabetes Association Media Release
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