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Press Release

DEVOTE trial shows lower rates of severe hypoglycaemia are associated with reduced risk of death

Novo Nordisk
Posted on: 17 Sep 17

Gatwick, UK, 15 September 2017 ­– Novo Nordisk today announced new post-hoc analyses from the DEVOTE trial showing that people with type 2 diabetes at high risk of cardiovascular disease who experience severe hypoglycaemia (low blood glucose levels, requiring 3rd party assistance) are at greater risk of death. The risk was four-fold higher (2.78 events/100 patient-years vs 11.23 events/100 patient-years) 15 days after an event and two and a half-fold higher (2.64 events/100 patient-years vs 7.32 events/100 patient-years) anytime following an episode of severe hypoglycemia1. In addition, results also showed that daily fluctuations in blood glucose levels in people with type 2 diabetes at high risk of cardiovascular disease are associated with a higher risk of death2. The results were presented at the European Association for the Study of Diabetes 53rd Annual Meeting (EASD)1.

Professor Ponnusamy Saravanan, Professor and Honorary Consultant Physician in Diabetes, Endocrinology & Metabolism, University of Warwick commented, “Hypoglycaemia is a disabling complication of diabetes and patients who have experienced hypoglycaemia are frightened, frequently resulting in relaxing their control. The heightened risk of death associated with having severe episodes make it an absolute priority to manage effectively when looking at overall diabetes care, along with maintaining target blood glucose levels. Having treatment options available that reduce the risk of severe hypoglycaemia is a reassuring clinical advancement.”


In the DEVOTE trial, there was no difference in the death rate between Tresiba®q (insulin degludec) and insulin glargine U100 (202 vs 221 patients; 2.67 vs 2.92 events / 100 patient-years hazard ratio 0.91; p=0.35 respectively). However, insulin degludec significantly reduced the rate of severe hypoglycaemia by 40% (3.70 events/100 patient-years with insulin degludec vs 6.25 events/100 patient-years with insulin glargine U100) and the rate of nocturnal severe hypoglycaemia by 53% (0.65 vs 1.40 events/100 patient-years) compared to insulin glargine  U100 in people with type 2 diabetes3.


Dr Avideh Nazeri, Director of Clinical, Medical and Regulatory, Novo Nordisk UK said,

“New evidence of reducing potentially life-threatening complications for people with diabetes is always welcome. At Novo Nordisk, optimum patient care is at the heart of what we do, so being able to offer a treatment that has been proven to reduce the risk of severe hypoglycaemia compared to glargine U100 is an important achievement”.



DEVOTE is a multinational, double blinded clinical trial which investigated the cardiovascular safety of insulin degludec 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 risk3.


The trial demonstrated that insulin degludec 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 control3.


About Tresiba®

Tresiba® (insulin degludec) is a once-daily basal insulin that provides a duration of action beyond 42 hours4. It is important for people with type 1 and type 2 diabetes to establish a routine for insulin treatment. On occasions when administration at the same time of day is not possible, insulin degludec allows for flexibility in day-to-day dosing time when needed4,5. A minimum of 8 hours between injections should be ensured.


Insulin degludec received its first regulatory approval in September 2012 and has since been approved in more than 60 countries globally.


About Novo Nordisk

Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care, and is committed to improving diabetes care and tackling the rise in diabetes. Novo Nordisk’s experience and capabilities enables them to also help people defeat other serious chronic conditions such as haemophilia, growth disorders and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 42,000 people in 77 countries and markets its products in more than 165 countries.


Further information

Becky Hess

+44 12 9361 3555

Lucia Giffard

+44 20 3761 4493

Daniel Bullock

+44 20 3761 4485



1.    Thomas R. Pieber, Steven P. Marso, Darren K. McGuire et al DEVOTE 3: temporal relationships between severe hypoglycaemia, cardiovascular outcomes and mortality. Diabetologia. 2017.

2.    Bernard Zinman, Steven P. Marso, Neil R. Poulter et al Day-to-day fasting glycaemic variability in DEVOTE: associations with severe hypoglycaemia and cardiovascular outcomes (DEVOTE 2). Diabetologia. 2017.

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.

4.    EMA. Tresiba® Summary of Product Characteristics. Available at: Last accessed: August 2017.

5.    Mathieu C, et al. Efficacy and safety of insulin degludec in a flexible dosing regimen vs insulin glargine in patients with type 1 diabetes (BEGIN: Flex T1): a 26-week randomized, treat-to-target trial with a 26-week extension. J Clin Endocrinol Meta. 2013;98:1154-62.




Novo Nordisk Ltd

Corporate Communications

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Beehive Ring Road


West Sussex



+44 1293 613555





Editor's Details

Mike Wood

Last updated on: 17/09/2017

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