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A Multicenter, International Randomized, 2x2 Factorial Design Study to Evaluate the Effects of Lantus (Insulin Glargine) Versus Standard Care, and of Omega-3 Fatty Acids Versus Placebo, in Reducing Cardiovascular Morbidity and Mortality in High Risk People With Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT) or Early Type 2 Diabetes Mellitus: The ORIGIN Trial (Outcome Reduction With Initial Glargine Intervention)

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A Multicenter, International Randomized, 2x2 Factorial Design Study to Evaluate the Effects of Lantus (Insulin Glargine) Versus Standard Care, and of Omega-3 Fatty Acids Versus Placebo, in Reducing Cardiovascular Morbidity and Mortality in High Risk People With Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT) or Early Type 2 Diabetes Mellitus: The ORIGIN Trial (Outcome Reduction With Initial Glargine Intervention)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 25 Jul 2024

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At a glance

  • Drugs Insulin glargine (Primary) ; Omega-3-acid ethyl esters (Primary)
  • Indications Cardiovascular disorders; Glucose intolerance; Type 2 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Acronyms ORIGIN; ORIGIN-GRACE; ORIGINALE
  • Sponsors Sanofi

    • Most Recent Events

    • 25 Jul 2024 Results of exploratory analysis assessing clinical and biochemical measurements that can identify people with dysglycaemia who remain free of serious outcomes during follow-up, published in the Diabetes, Obesity and Metabolism.
    • 28 Aug 2023 Results of biomarker substudy within the ORIGIN (n=8,494) assessing the relationship between SHBG levels and heart failure hospitalizations in men and women with dysglycemia presented at the ESC Congress 2023 - Annual Congress of the European Society of Cardiology
    • 01 Mar 2023 Results(n=7017) Identifying blood biomarkers for type 2 diabetes subtyping using up to six routinely measured clinical variables published in the Diabetologia

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