Death Risk Up in T2D Patients Following Severe Hypoglycemia Episode
At the 53rd Annual Meeting of the European Association of the Study of Diabetes (EASD) in Lisbon, Portugal, researchers presented data from the DEVOTE trial (a cardiovascular outcomes trial comparing two basal insulins) which showed that patients with type 2 diabetes may be at an increased risk of death following an episode of severe hypoglycemia.
Specifically, there was 2.5-fold greater risk anytime after an episode of severe hypoglycemia with the risk 4-fold higher 15 days after an event. Additional data showed that an increased risk of death was linked to patients with daily fluctuations in their blood glucose levels.
The DEVOTE trial was a double-blind, multinational study comparing the cardiovascular safety of Tresiba (insulin degludec; Novo Nordisk) with insulin glargine U100 over 104 weeks; it enrolled over 7,500 patients with type 2 diabetes. All patients had either an existing or high risk of cardiovascular disease and were already receiving standard treatment.
In the study, Tresiba lowered the rate of severe hypoglycemia by 40% and the rate of nocturnal severe hypoglycemia by 53% vs. insulin glargine U100. These reductions were similar to those observed in the SWITCH 2 trial where there were 51% lower rates of severe hypoglycemia during the treatment period, and a 42% lowered rate of nocturnal hypoglycemia vs. insulin glargine U100.
Tresiba, a basal insulin, has also been associated with significantly less variation in blood glucose levels vs. insulin glargine U100 and U300 (Heise T 2017; Haahr H 2014). It is currently approved to improve glycemic control in patients with diabetes mellitus.
Dr. Bernard Zinman, Mount Sinai Hospital, University of Toronto, Canada, noted, "These results highlight the importance of maintaining low variability in blood sugar levels and reducing the risk of severe hypoglycemia when treating people with type 2 diabetes."
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