No Clear Winner in Diabetes Treatment Trial

Patient needs may dictate which combo of drugs plus insulin works best, researchers say

By Ed Edelson
HealthDay Reporter

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FRIDAY, Sept. 21 (HealthDay News) -- A study designed to tell which insulin-plus-drug regimen might best control type 2 diabetes has produced disappointing preliminary results, with none of the three strategies tested coming out on top.

"What this shows is that none of the strategies in the study can be recommended" as being superior to the other, said Dr. Graham T. McMahon, an assistant professor of medicine at Brigham and Women's Hospital in Boston, and co-author of an editorial accompanying the report, published online Friday in the New England Journal of Medicine.

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Instead, he said, the insulin regimen would probably have to be tailored to each patient, McMahon said.

The report was released early, because the preliminary, one-year results of the four-year study are being presented at a meeting of the European Association for the Study of Diabetes, in Amsterdam.

The study, led by British diabetes specialists at the University of Oxford, included 708 participants with type 2 diabetes. Type 2 diabetes, which affects about 95 percent of diabetics, typically occurs in adulthood and is often tied to obesity.

All of the trial participants were given maximum doses of two diabetes drugs, metformin and sulfonylurea, and a different regimen of injected insulin three times a day, two times a day or just once a day. The once-a-day group got an extra dose if deemed necessary.

The goal was to reduce blood levels of glycolated hemoglobin, which forms when sugar enters blood cells, to 6.5 percent or less.

The results overall were not impressive: The treatment goal was achieved by just 23.9 percent of those getting insulin three times a day, 17 percent of those getting insulin twice a day and 8.1 percent of those in the once-a-day group, the researchers reported.

The greater success rate in the two- and three-times-a-day regimen had a down side, the team noted, since it was also accompanied by an increased incidence of weight gain and low blood sugar levels, the report said.

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