Bagsværd, 29 November 2016 - Today, Novo Nordisk announced the headline results from the DEVOTE trial, a long-term, randomised, double-blinded and event-driven trial conducted to confirm the cardiovascular safety of Tresiba® (insulin degludec) compared to insulin glargine U100 when added to standard of care. In the trial, more than 7,500 people with type 2 diabetes at high risk of major adverse cardiovascular events were treated for a period of approximately two years.
The trial achieved its primary endpoint by demonstrating non-inferiority of major adverse cardiovascular events (MACE) with Tresiba® compared to insulin glargine U100. The trial thereby confirmed the results of the DEVOTE interim analysis submitted to the US Food and Drug Administration (FDA) in March 2015, on the basis of which Tresiba® and Ryzodeg® 70/30 were approved in the US in September 2015.
The primary endpoint of the DEVOTE study was defined as the MACE composite outcome of the first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke and showed a hazard ratio of 0.91 in favour of Tresiba® relative to insulin glargine U100, with no statistically significant difference between the two treatments.
From a mean HbA1c baseline of 8.4%, the trial showed a similar reduction with Tresiba® compared to insulin glargine U100 with an end-of-trial treatment difference of 0.01 percentage-points between the two treatment arms, thus fulfilling the requirements for objectively comparing hypoglycaemia rates between the two treatments.
In the trial, Tresiba® demonstrated superiority on the secondary confirmatory endpoint of severe hypoglycaemia: 27% fewer patients in the Tresiba® treated group experienced an episode of severe hypoglycaemia, resulting in a 40% overall reduction of total episodes of adjudicated severe hypoglycaemia. Furthermore, patients in the Tresiba® treated group experienced a 54% relative reduction in the rate of nocturnal severe hypoglycaemia. These differences were all statistically significant.
Tresiba® appeared to have a safe and well-tolerated profile consistent with previous clinical studies conducted with Tresiba®.
"We are very pleased that the DEVOTE study demonstrates the cardiovascular safety of Tresiba® and also confirms the hypoglycaemia benefit of this new generation insulin. Severe hypoglycaemia remains the most serious treatment risk related to insulin therapy. The DEVOTE results further strengthen the potential of Tresiba® to become the new standard of care within basal insulin therapy," says Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.
Novo Nordisk expects to present the detailed results of the DEVOTE trial at a scientific meeting and submit the findings for review with regulatory authorities during the first half of 2017.
On 30 November 2016 at 8.00 am CET, corresponding to 2.00 am EST, a conference call for investors will be held. Investors will be able to listen in via a link on the investor section of novonordisk.com.
DEVOTE is a long-term, multi-centre, multi-national, randomised, double-blinded, parallel group and event-driven trial conducted to confirm the cardiovascular safety of Tresiba® (insulin degludec) compared to insulin glargine U100. In the trial, 7,637 people with type 2 diabetes at high risk of cardiovascular disease were randomised to treatment with either Tresiba® or insulin glargine U100 in vial in addition to standard of care.
The DEVOTE trial has been conducted in response to a Complete Response Letter received from the FDA in February 2013 requesting additional cardiovascular data from a dedicated cardiovascular outcomes trial before the review of the New Drug Applications for Tresiba® and Ryzodeg® 70/30 could be concluded. Tresiba® and Ryzodeg® 70/30 were approved in the US in September 2015 on the basis of an interim analysis of DEVOTE.
Tresiba® (insulin degludec) is a once-daily basal insulin that provides duration of action of at least 42 hours. Tresiba® is taken once daily, at any time of day. Patients who miss or are delayed in taking their dose of Tresiba® can take their dose as soon as they remember, but ensuring there are at least eight hours between doses. Tresiba® received its first regulatory approval in September 2012 and has since been approved in more than 80 countries globally. It was approved by the US FDA in September 2015.
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Company announcement No 84 / 2016Attachments: