A clinical trial demonstrated the safety and efficacy of Tresiba (insulin degludec) insulin and showed that it provides a significant reduction in rates of severe hypoglycemia (low blood sugar) in patients with type 2 diabetes when compared to Lantus (insulin glargine).
Researchers also found that Tresiba was as safe as Lantus in that it showed no increased risk of major cardiovascular events.
Novo Nordisk announced in a press release that the primary results from the DEVOTE trial–a randomized, double-blind, treat-to-target, event-driven trial that compared Tresiba (insulin degludec injection U/mL) and Lantus (insulin glargine U100) in adults with type 2 diabetes who were considered at high risk for heart disease.
Involved in the trial were 7,637 people with type 2 diabetes who were followed for approximately two years.
Tresiba VS Lantus
The trial meant to find out if Tresiba was non-inferior to Lantus regarding major adverse cardiovascular events. Tresiba is indeed non-inferior in this way according to this study.
In addition, Tresiba demonstrated an impressive 40 percent reduction in the rate of severe hypoglycemia and a startling 53 percent reduction in the rate of overnight severe hypoglycemia when compared to Lantus.
The researchers noted that “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.”
Not just this but similar levels of blood sugar management were observed with an end-of-trial A1c estimated treatment difference of 0.01 percent between the two groups and much lower fasting blood sugar levels with Tresiba after 2 years when compared to Lantus.
A Big Plus for Type 2 Diabetes Patients on Basal Insulin
These results were presented at the 2017 American Diabetes Assocation’s 77th Scientific Sessions and are published in the New England Journal of Medicine.
Dr. Bernard Zinman of the Lunenfeld-Tanenbaum Research Institute at Mount Sinai Hospital, Toronto, Canada and member of the DEVOTE Steering Committee said in the press release:
“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,” and that “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.”
Tresiba Doing Well in Clinical Trials and According to Patients
Tresiba is a basal or long-acting insulin taken once a day and indicated for patients 1 year of age and older. It has been found in recent studies to reduce the incidence of overnight hypoglycemia in patients with type 1 diabetes and now in patients with type 2 diabetes.
Tresiba is marketed by Novo Nordisk and comes in a FlexTouch insulin delivery device as a 100 units/mL or 200/mL pen.
It was approved by the US FDA in September of 2015 and has since become well-liked by patients with type 1 and 2 diabetes.
Photo Credit: Lantus.com