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Research

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ORIGIN

Official Title

The ORIGIN Trial (Outcome Reduction with Initial Glargine Intervention)

Status

Completed

Overview

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.

Study Design

Randomized, treatment, open label, active control, factorial assignment, efficacy study.

Primary Endpoint

The composite of CV death, non-fatal MI, non-fatal stroke, and significant heart failure. Secondary endpoints: Decline in the ability to perform everyday activities (key secondary outcome), Renal dysfunction (Primary outcome: end stage renal disease [ESRD] requiring dialysis or transplantation or doubling of serum creatinine), Total mortality. All primary and secondary endpoints are adjudicated.

Number of Patients

12612

Number of Sites

578

Number of Countries

40

Study Period

2003–2010

Principal Investigator

Hertzel Gerstein, Salim Yusuf

Program Manager

Jackie Bosch

Research Coordinator

Jessica Tyrwhitt

Key Publications

  • Origin Trial Investigators, Gerstein H, Yusuf S, Riddle MC, Ryden L, Bosch J. Rationale, design, and baseline characteristics for a large international trial of cardiovascular disease prevention in people with dysglycemia: the ORIGIN Trial (Outcome Reduction with an Initial Glargine Intervention).Am Heart J. 2008;155:26-32, 32.e1-6. Epub 2007 Nov 26.
  • The ORIGIN Trial Investigators (2012). Basal insulin and cardiovascular and other outcomes in dysglycemia. N Engl J Med 26;367(4):319-28.
  • The ORIGIN Trial Investigators (2012). n-3 fatty acids and cardiovascular outcomes in patients with dysglycemia. N Engl J Med 26;367(4):309-18.

For more information, please visit http://www.origintrial.org/