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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

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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

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 12 Dec 2022

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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

  • 11 Jun 2019 Results of post hoc subgroup analysis of ODYSSEY DM-DYSLIPIDEMIA trial investigating effect of Alirocumab in individuals with type 2 diabetes and high triglycerides and low high-density lipoprotein cholesterol presented at the 79th Annual Scientific Sessions of the American Diabetes Association
  • 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.

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