Healthcare Professionals: Design & Organization
Design & Organization
ORIGIN was a multicenter, international, randomized, open-label (for insulin glargine versus standard care), double-blind (for n-3 PUFA versus placebo), 2x2 factorial study.
12,537 participants with dysglycemia (type 2 diabetes, IFG, or IGT) who were either drug naïve (i.e. on no glucose lowering drugs) or taking 1 glucose lowering drug and who had additional cardiovascular risk factors were studied.
Participants were randomly assigned to receive either insulin glargine treatment or standard care. People randomly allocated to the insulin glargine group added a once daily subcutaneous injection of Lantus (insulin glargine) to their regimen and titrated the dose to target a FPG of ≤95 mg/dL (5.3 mM). People randomly allocated to standard care who had diabetes managed their glucose levels based on local guidelines and their physician’s best judgment; nondiabetic participants randomized to standard care were followed for the development of diabetes. All participants were encouraged to modify their lifestyle appropriately.
Participants were also randomly assigned to receive either an omega-3 polyunsaturated fatty acid (Omacor®) or matching placebo.
Routine visits occurred 2, 4, 8, and 16 weeks following randomization, then every 4 months for a median of 6.2 years.
An international Steering Committee led the trial which was managed by the Population Health Research Institute in Hamilton, Ontario, Canada. All primary and secondary clinical cardiovascular outcomes (cardiovascular death, myocardial infarction, stroke, hospitalization for heart failure, and revascularization procedure) as well as cancers were confirmed by an Event Adjudication Committee that remained blinded to the participant treatment allocation. The interim reviews of outcome and safety data were conducted in an unblinded manner by an Independent Data Monitoring Committee.