Tresiba® Demonstrated No Increased Risk Of Major Cardiovascular Events and Significant Reduction in Rates of Severe Hypoglycaemia Compared to Insulin Glargine U100 in the DEVOTE Trial

SAN DIEGO, June 12, 2017 /PRNewswire/ --

Symposium: 3-CT-SY22

Novo Nordisk today announced the primary results from DEVOTE - the first randomised, double-blind, treat-to-target, event-driven trial comparing two basal insulins, Tresiba^® (insulin degludec injection 100 U/mL) and insulin glargine U100, in adults with type 2 diabetes at high risk of cardiovascular (CV) disease. The trial demonstrated that Tresiba^® met the primary endpoint of non-inferiority compared with insulin glargine U100 for major adverse CV events (MACE) with a hazard ratio (HR) of 0.91 (95% confidence interval [CI]: 0.78; 1.06, p=0.209). Additionally, the findings for each component of MACE were consistent with the primary endpoint, including first occurrence of CV death (HR=0.96, 95% CI: 0.76; 1.21, p=0.714), non-fatal myocardial infarction (HR=0.85, 95% CI: 0.68; 1.06, p=0.150) or non-fatal stroke (HR=0.90, 95% CI: 0.65; 1.23, p=0.502).^[1]

Results from the trial, involving 7,637 people with type 2 diabetes followed for approximately two years, were presented at the American Diabetes Association's 77^th Scientific Sessions (ADA 2017) and also published simultaneously in the New England Journal of Medicine.^[1]

Results from the secondary endpoints of the trial showed a significant reduction in the rate of severe (40%) and nocturnal severe (53%) hypoglycaemia with Tresiba^® vs. insulin glargine U100 (both p<0.001).* Additionally, post hoc analyses showed: similar levels of glycaemic control with an end of trial HbA_1c estimated treatment difference of 0.01% (p=0.779) between the two treatment groups and significantly lower fasting plasma glucose levels with Tresiba^® after 2 years vs. insulin glargine U100 (estimated treatment difference -7.2 mg/dL, p<0.001).^[1]

"In the DEVOTE trial degludec demonstrated no increase in the risk of major cardiovascular events and significant reductions in the rates of severe and nocturnal severe hypoglycaemia compared to insulin glargine U100," said Dr Bernard Zinman of the Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, Toronto, Canada and member of the DEVOTE Steering Committee. "Risk of cardiovascular disease and hypoglycaemia are important concerns for those with type 2 diabetes and the results from DEVOTE add to the mounting evidence that will play an important role in treatment decisions."

The safety profile of Tresiba^® in DEVOTE was generally consistent with previous Tresiba^® clinical trials.^[1] In DEVOTE, systematic collection of adverse events was limited to serious adverse events, adverse events leading to permanent discontinuation of investigational product (5.2% of patients in the Tresiba^® arm and 5.8% of patients in the insulin glargine U100 arm), medication errors leading to serious adverse events and adverse events related to technical complaints.  

*Severe hypoglycaemia was defined as an episode requiring assistance of another person, and nocturnal severe defined as between the hours of 00:01-05:59, inclusive.^[1]

About DEVOTE 

DEVOTE is a long-term, multi-national, randomised, double-blind and event-driven trial conducted to confirm the CV safety of Tresiba^® (insulin degludec) compared to insulin glargine U100. In the trial, 7,637 people (Tresiba^®: n=3,818, insulin glargine U100: n=3,819) with type 2 diabetes at high risk of CV disease were randomised to treatment with either Tresiba^® or insulin glargine U100 in vial in addition to standard of care.^[1]

The primary endpoint in DEVOTE was time from randomisation to the first occurrence of a three-component composite CV outcome comprising CV death, non-fatal myocardial infarction or non-fatal stroke. Secondary endpoints included severe hypoglycaemia, nocturnal severe hypoglycaemia, HbA_1c and fasting plasma glucose.^[1]

About Tresiba^® 

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.^[2],[3] It provides low within-day and day-to-day variability and a lower risk of overall, nocturnal and severe hypoglycaemia vs. insulin glargine U100.^[1],[2] 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.^[2] 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.

About Novo Nordisk 

Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: 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. For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube  

References 

1. Cardiovascular Safety of Insulin Degludec vs. Insulin Glargine in Patients with Type 2 Diabetes at High Risk of Cardiovascular Events (DEVOTE) Trial Results. Symposium 3-CT-SY22 at the 77^th Scientific Sessions of the American Diabetes Association (ADA). 12 June 2017. Manuscript in press.

2. 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: June 2017.

3. Haahr H, Heise T. A review of the pharmacological properties of insulin degludec and their clinical relevance. Clin Pharmacokinet. 2014; 53:787-800.

Further information
Media:
Katrine Sperling
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Michael Bachner (US)
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mzyb@novonordisk.com

Investors:
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Hanna Ögren
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Anders Mikkelsen
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Kasper Veje (US)
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kpvj@novonordisk.com