The trial enrolled more than 7,500 type 2 diabetes patients at high risk of adverse cardiovascular events and treated them for 2 years with either Tresiba or insulin glargine U100. The long term analysis sought to confirm interim data that the Denmark-based company used to support its FDA approval for Tresiba in September last year.
The Devote trial met its primary endpoint, demonstrating non-inferiority of major adverse cardiovascular events with the injected insulin degludec compared to insulin glargine. There was no statistical difference between the 2 treatments and their safety profiles, the company reported.
From a mean HbA1c baseline of 8.4%, Tresiba demonstrated a similar reduction in blood sugar compared to insulin glargine U100. The basal insulin injection met its secondary endpoint, in which 27% fewer patients in the Tresiba arm experienced severe hypoglycemia. Patients in the Tresiba group also experienced a 54% relative reduction in the rate of nocturnal severe hypoglycemia.
“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,” executive VP & chief science officer Mads Krogsgaard Thomsen said in prepared remarks. “The Devote results further strengthen the potential of Tresiba to become the new standard of care within basal insulin therapy.”
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