The ORIGIN trial (Outcome Reduction with an Initial Glargine INtervention) randomized more than 12,500 people with dysglycemia (elevated glucose levels due to impaired fasting glucose, impaired glucose tolerance or early diabetes) to one injection of insulin glargine per day versus usual care. It is determining whether targeting normal fasting glucose levels with insulin glargine reduces cardiovascular outcomes compared to standard management. Participants have been followed for an average of four years to date for a total exposure of more than 50,000 person-years. Data are collected related to all major serious health outcomes, including cancers. Accumulating data are reviewed regularly by an Independent Data Monitoring Committee charged with auditing the safety of the trial. In light of the questions raised by the recent publication, this committee of experts has recently reviewed data related to cancers in both treatment groups and has concluded that there is no cause for concern and no reason to alter the design of the study for safety reasons.

The study is due to end in 2011, when detailed analyses will be published. In the meantime, the data will continue to be collected and audited for safety by this independent group. To maintain a high-quality and unbiased study, researchers and the manufacturer of insulin glargine do not (and will continue to not) have access to data summarizing outcomes by treatment group until the study is over.

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