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Prof David Nathan, Director of the MGH Diabetes Centre and Clinical Research Centre, and Professor of Medicine, Harvard Medical School, US, is leading GRADE, the first comparative effectiveness study of major pharmacologic treatments in metformin-treated type 2 diabetes patients.
Speaking to the Medical Independent (MI) at the recent Irish Endocrine Society 2016 Annual Meeting, Prof Nathan said there is no business model or incentive for the pharmaceutical industry to conduct such major head-to-head trials.
He said the reason for this is because companies are anxious their own products might not do well in any such trial.
“There has been no incentive for the group that funds most of this kind of research to do it, therefore it is left up to governments to do it,” he said.
GRADE has been funded by the National Institute of Diabetes and Digestive and Kidney Diseases in the US, part of the National Institutes of Health (NIH).
It is a randomised clinical trial of participants diagnosed with type 2 diabetes within the past 10 years who are already on metformin. Participants will be randomly assigned to one of four commonly-used glucose-lowering drugs (glimepiride, sitagliptin, liraglutide and basal insulin glargine), plus metformin, and will be followed for up to seven years. The goal of the GRADE study is to determine which combination of two diabetes medications is best for achieving good glycaemic control, has the fewest side-effects, and is the most beneficial for overall health in long-term treatment for people with type 2 diabetes.
“It is looking at people who are relatively early on in their diabetes, who have diabetes control that is in a modest range, that is typical for when people first develop diabetes,” according to Prof Nathan.
“They are already on metformin and we just make sure they are on the maximum dose of metformin they will tolerate. Then we randomly assign them to one of the foremost common agents as a second drug, and then we compare them. We compare them not over three months or six months or a year, but over four, five and seven years. And that is the kind of period we are talking about. That is even short, but that is what we can afford to do. So we will do it as long as we can and determine hopefully, for the first time, which are the better drugs to use for individual patients and for groups of patients.”
See pages 42-46 for full exclusive coverage of the Irish Endocrine Society 2016 Annual Meeting