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A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Alirocumab in Insulin Treated Patients With Type 1 or Type 2 Diabetes and With Hypercholesterolemia at High Cardiovascular Risk Not Adequately Controlled on Maximally Tolerated LDL-C Lowering Therapy

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Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Alirocumab in Insulin Treated Patients With Type 1 or Type 2 Diabetes and With Hypercholesterolemia at High Cardiovascular Risk Not Adequately Controlled on Maximally Tolerated LDL-C Lowering Therapy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Dec 2022

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At a glance

  • Drugs Alirocumab (Primary)
  • Indications Hypercholesterolaemia
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms ODYSSEY DM - Insulin
  • Sponsors Sanofi

    • Most Recent Events

    • 11 Jun 2017 Primary endpoint has been met. (Percent change in calculated LDL-C in the intent to treat (ITT) population), according to a Regeneron Pharmaceuticals media release.
    • 11 Jun 2017 Additional results from patients with T1D will be extracted and reported at a later date, as per an American Diabetes Association Media Release.
    • 11 Jun 2017 Results from patients with type 2 diabetes (n=441) published in the American Diabetes Association Media Release

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