Novo Nordisk A/S Release: Tresiba Trial Shows That People With Type 2 Diabetes Who Avoid Severe Hypoglycemia Have A Reduced Risk Of Death
Lisbon, Portugal, 15 September 2017 - Novo Nordisk today announced new analyses from the multinational, double-blinded DEVOTE trial showing that people with type 2 diabetes who experience severe hypoglycaemia (low blood sugar levels) are at greater risk of death. The risk was four-fold higher 15 days after an event and two and a half-fold higher anytime following an episode of severe hypoglycaemia.1 In addition, results also showed that daily fluctuations in blood sugar levels in people with type 2 diabetes are associated with a higher risk of death. The results were presented at the European Association for the Study of Diabetes 53rd Annual Meeting (EASD) and simultaneously published in Diabetologia.1,2
"Episodes of severe hypoglycaemia are not only distressing for patients and potentially dangerous, they are also associated with an increased risk of death," said Dr Bernard Zinman of the Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Canada and member of the DEVOTE Steering Committee. "These results highlight the importance of maintaining low variability in blood sugar levels and reducing the risk of severe hypoglycaemia when treating people with type 2 diabetes."
In the DEVOTE trial, Tresiba® (insulin degludec) reduced the rate of severe hypoglycaemia by 40% and the rate of nocturnal severe hypoglycaemia by 53% compared to insulin glargine U100 in people with type 2 diabetes.3 Similar reductions were seen in the SWITCH 2 trial with 51% lower rates of severe hypoglycaemia during the full treatment period of the trial and a 42% reduction in the rate of nocturnal hypoglycaemia compared to insulin glargine U100 in people with type 2 diabetes.4
Studies have also shown that Tresiba® provides significantly lower variability in blood sugar levels compared to insulin glargine U100 and U300.5,6
DEVOTE is a multinational, double-blinded clinical trial which investigated the cardiovascular safety of Tresiba® compared with insulin glargine U100 over 104 weeks. DEVOTE is the first cardiovascular outcomes trial (CVOT) comparing two basal insulins and enrolled more than 7,500 people with type 2 diabetes. All participants had a high risk of, or existing, cardiovascular disease and were already receiving standard of care to reduce their cardiovascular risk.3 The trial demonstrated that Tresiba® does not increase cardiovascular risk compared with insulin glargine U100, and provides a significant reduction in the rate of severe and nocturnal severe hypoglycaemia at similar levels of glycaemic control.3
Tresiba® (insulin degludec) is a once-daily basal insulin that provides a duration of action beyond 42 hours with a flat and stable glucose-lowering effect.6,7 It provides low variability in blood glucose levels and a lower risk of overall, nocturnal and severe hypoglycaemia vs. insulin glargine U100.3,7 On occasions when administration at the same time of day is not possible, Tresiba® allows for flexibility in day-to-day dosing time with a minimum of eight hours between injections.7 Tresiba® received its first regulatory approval in September 2012 and has since been approved in more than 80 countries globally. It is now commercially available in more than 50 countries.
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1. Zinman B, Marso SP, Poulter NR, et al. Day-to-day fasting glycaemic variability in DEVOTE: associations with severe hypoglycaemia and cardiovascular outcomes (DEVOTE 2). Diabetologia. 2017; TBC:TBC. (In press).
2. Pieber TR, Marso SP, McGuire DK, et al. DEVOTE 3: temporal relationships between severe hypoglycaemia, cardiovascular outcomes and mortality. Diabetologia. 2017; TBC:TBC. (In press).
3. Marso SP, McGuire DK, Zinman B, et al. Efficacy and safety of degludec versus glargine in type 2 diabetes. N Engl J Med. 2017; 377:723-732.
4. Wysham C, Bhargava A, Chaykin L, et al. Effect of insulin degludec vs insulin glargine U100 on hypoglycemia in patients with type 2 diabetes: The SWITCH 2 randomized clinical trial. JAMA. 2017; 318:45-56.
5. Heise T, Norskov M, Nosek L, et al. Insulin degludec: Lower day-to-day and within-day variability in pharmacodynamic response compared with insulin glargine 300 U/mL in type 1 diabetes. Diabetes Obes Metab. 2017; 19:1032-1039.
6. Haahr H, Heise T. A review of the pharmacological properties of insulin degludec and their clinical relevance. Clin Pharmacokinet. 2014; 53:787-800.
7. EMA. Tresiba® Summary of Product Characteristics. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002498/WC500138940.pdf. Last accessed: September 2017.