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Medicine Matters diabetes

The patients that might benefit the most from basal insulins, and especially the newer basal insulins, are those that are prone to hypoglycemia. We know that the newer basal insulins definitely have reduced risk of hypoglycemia, especially compared to our older insulins, our human insulins, as well as our first generation insulins. So that's where we want to look and see where we might find the most benefit for those populations.



It's important to look at some of these differences, because there might be nuances between insulins, especially the newer insulins. We know that when we compared the newer insulins to the older insulins, we found differences. Now we want to take one step even further, and see if there might be differences between the two newer insulins that are available, which is degludec and glargine U300.



Why do you think degludec U200 did not reduce the overall rate of symptomatic hypoglycemia compared with U300 in CONCLUDE, but did reduce the risk for some secondary endpoints?

The primary outcomes of this study showed no difference which indicates that there may have been this may not have been the best measure to make for this study, and for this population. So it could be that nocturnal or severe [hypoglycemia] may have been a better outcome to look at. It could be that we needed a longer period of time. I think there's a number of differences that we could consider. All the other outcomes that we found were exploratory. They were hypothesis generating. They were not conclusive.



But I do think this provides direction for us, in a higher risk population, which is what CONCLUDE actually looked at. Maybe we do need to look at different time periods, and when some of these different insulins might make a difference.



How do the CONCLUDE results compare with real-world study findings?

There are a number of real world study findings out there already. And interestingly, they also have diverse, conflicting outcomes. And unfortunately, the results of the Conclude don't help us define and analyze these a little bit better, or even interpret these in a better way. It adds, though, to the literature, and potentially generates more information for what the next set of studies should be.



I do think that we should be using things like continuous glucose monitoring, and other methods of collecting hypoglycemia, which might allow us to find unknown and hidden time periods when hypoglycemia might be more frequent. And then these different insulins might make that difference.