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).

Trial Profile

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).

Completed
Phase of Trial: Phase III

Latest Information Update: 15 Sep 2017

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

    • 15 Sep 2017 Results of association of IGFPB-3 biomarker and BMI and T2D prevalence presented at the 53rd Annual Meeting of the European Association for the Study of Diabetes
    • 15 Sep 2017 Results of prediction of heart failure hospitalisation by using nover biomarkers data from ORIGIN study presented at the 53rd Annual Meeting of the European Association for the Study of Diabetes
    • 22 Aug 2017 Results (n=12,174) of a post-hoc analysis comparing cardiovascular outcomes in subjects without to those with mild (Stages 1-2) and/or moderate chronic kidney disease (Stage 3), published in the American Journal of Medicine.
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