Munich, Germany A sub-study of the Outcome Reduction with an Initial Glargine Intervention (ORIGIN) trial, designed to investigate the effect of insulin glargine and omega-3 fatty acids on atherosclerosis progression, has found that, compared to standard care, only insulin glargine (a long-acting insulin) had a "modest" statistically non-significant reducing effect on the primary outcome of rate of change in maximum carotid intima media thickness (CIMT) at 12 carotid sites.
However, while insulin glargine did significantly reduce the secondary outcomes of the study (the annualised rates of change in maximum CIMT for the common carotid artery and for the common carotid plus bifurcation sites), there was no differences in either the primary or secondary outcomes between the omega-3 polyunsaturated fatty acid supplements and placebo groups.
"Our study demonstrates that in high-risk people with established cardiovascular disease or with cardiovascular risk factors plus type 2 diabetes or pre-diabetes, insulin glargine modestly retards the progression of atherosclerosis," said first investigator Professor Eva Lonn, Professor of Medicine and Population Health Research Scientist at McMaster University, Hamilton, Ontario, Canada.
As background to the trial, known as the Glucose Reduction and Atherosclerosis Continuing Evaluation Study (GRACE) study, Professor Lonn explained that the effects of treatment with insulin titrated to normalise fasting plasma glucose levels and with omega-3 polyunsaturated fatty acid supplements (fish oil supplements) on atherosclerosis progression in people with type 2 diabetes or pre-diabetes are unknown.
The GRACE study assessed the effects of insulin glargine and omega-3 fatty acids by performing yearly high-resolution carotid ultrasound examinations for five years and detailed precise measurements of CIMT. Patients were recruited from 32 centers in seven countries. At baseline patients' mean age was
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