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“ORIGIN” Outcome Reduction with Initial Glargine Intervention
 
Sponsor Aventis
 
Principal Investigators
  • Hertzel Gerstein, MD,
McMaster University Faculty of Health Sciences, Hamilton, Ontario, Canada
  • Salim Yusuf, MD,
McMaster University Faculty of Health Sciences, Hamilton, Ontario, Canada
 
Principal Investigator for U.S. Regional Coordinating Center
    Jeffery Probstfield, MD, University of Washington School of Medicine
 
Berman Center Site Investigators
    Principal Investigator: Richard Grimm, MD, PhD
 
Co-Investigators
  • Sidney A. Jones, MD,
Hennepin Faculty Associates Division of Endocrinology, Diabetes, and Metabolism
  • Sandra Graham, NP, Berman Center for Outcomes and Clinical Research
 
Berman Center Coordinator
   

Sandra Graham, RN, 612-341-7923

 
 
Description
    ORIGIN is a 2x2 factorial study investigating the prevention of cardiovascular morbidity and mortality in people with type II diabetes, impaired glucose tolerance, and/or fasting glucose ≥110 mg/dL. The two factors are insulin glargine (variable dose vs. standard care), and omega-3 fatty acid (865mg vs. placebo). Participants are randomized to one of the four possible treatment combinations.
 
Role of the Berman Center
    The Berman Center is one of 24 clinical sites in the U.S., and one of 600 clinical sites across the world. The Berman Center site will enroll 40 participants between October 2003 and the summer of 2005 and follow each participant for five years. Berman Center doctors, nurse practitioners, and research nurses will complete all study visits.
 
Basic enrollment information
    Participants must be 50 years or older with elevated blood sugar levels (Type 2 diabetes, impaired fasting glucose, or impaired glucose tolerance) and history of cardiovascular disease (including but not limited to heart attack, stroke, or angina). Individuals with Type I diabetes are not eligible for this study.
 
Abstract
    Two-thirds of the people who experience a heart attack have impaired fasting glucose (IFG), impaired glucose tolerance (IGT) and/or early Type 2 Diabetes Mellitus. Recent studies suggest that using insulin to lower blood sugar may reduce the risk of future cardiovascular events. Other studies have suggested that omega-3 fatty acids, an oil found naturally in fish, can also reduce the risk of cardiovascular events, possibly by reducing harmful fats in blood that can lead to arteriosclerosis.
   
Using a 2x2 factorial design, ORIGIN compares efficacy of both treatments, separately and together, for 5-year incidence of CVD events, in 10,000 individuals with impaired fasting glucose (IFG), impaired glucose tolerance (IGT) and/or early Type 2 Diabetes Mellitus.
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