June 21, 2012

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Hi. I'm Dr. Anne Peters from the University of Southern California, reporting from Philadelphia where I am attending the American Diabetes Association Annual Meeting. Among other things, the results of the ORIGIN trial were revealed.[1]

ORIGIN was a multiyear, large trial involving over 12,500 participants, with a primary focus in Canada, looking at whether using insulin early in the treatment of both prediabetes and diabetes is safe and effective. It also looked at whether giving omega-3 fatty acid supplementation would benefit cardiovascular disease in this same population.

The study group consisted of patients who had prediabetes, impaired glucose tolerance, impaired fasting glucose, and those who had early type 2 diabetes. Patients were on no medications or just 1 medication -- that was not insulin -- for the treatment of diabetes. They were then randomly assigned to receive insulin glargine. The dose was titrated to keep blood sugars at < 95 mg/dL. The placebo arm was given oral medications instead of insulin to treat their diabetes, as would be done routinely.

The investigators followed these patients and looked at a number of things. They were hoping to see a reduction in cardiovascular events in patients who received early insulin therapy. Patients on insulin glargine would have a reduction in both their fasting glucose levels as well as their postprandial glucose levels. However, they did not see a reduction in macrovascular events.

The good news is that macrovascular events did not worsen. This was a large trial, and I think it is pretty safe to say that this showed that the early use of insulin in type 2 diabetes does not increase the risk for macrovascular events.

Similarly, the risk for cancer did not increase. There has been some concern that glargine might be associated with an increased risk for cancer, but that has been based on epidemiologic studies. This was a randomized controlled trial, and the investigators did not see an increase in the risk for cancer in patients treated with insulin glargine.

They did see, as would be expected, more hypoglycemia and slightly more weight gain in glargine-treated patients compared with those who were not on glargine. Finally, they did see some degree of prevention of progression from prediabetes to diabetes in those who were treated with glargine compared with placebo.

Early use of insulin actually helped to prevent the development of type 2 diabetes. When they looked at omega-3 fatty acids, no reduction in macrovascular events was found in patients who were given omega-3 fatty acids compared with those who weren't.

I think this study reinforces the safety of insulin glargine used in a large population with early diabetes. Whether we as clinicians use glargine early may not exactly change here. I think that there are some patients, perhaps leaner patients, in whom I may start insulin earlier. In some of those patients, I have hoped that that helped progression, especially if they were very early. Now we know that it does. For most patients, we will probably still use insulin somewhat later in the disease progression, but certainly without fear that it will cause cardiovascular events or cancer.

This has been Anne Peters for Medscape. Thank you.

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