The ORIGIN Trial (Outcome Reduction with Initial Glargine Intervention)
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.
Randomized, treatment, open label, active control, factorial assignment, efficacy study.
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.
Hertzel Gerstein, Salim Yusuf