Novo Nordisk’s DEVOTE study reveals interesting findings.
Novo Nordisk recently announced the primary results from a study comparing Tresiba (insulin degludec injection 100 units/mL, Novo Nordisk) to insulin glargine 100 units/mL.
The DEVOTE study was the first randomized, double-blind, treat-to-target, event-driven trial comparing the 2 basal insulins in adults with type 2 diabetes at high risk of cardiovascular (CV) disease. The results of the trial were presented at the American Diabetes Association’s 77th Scientific Sessions (ADA 2017) and published in the New England Journal of Medicine.
Tresiba is a once-daily basal insulin used to control high blood sugar in adults and children who are aged 1 year and older with diabetes.
The DEVOTE study involved 7,637 people with type 2 diabetes followed for approximately 2 years. Patients were randomized to receive either Tresiba (3818 patients) or insulin glargine U100 in vial (3,819 patients) in addition to standard of care.
Results of the trial demonstrated that Tresiba met the primary end point of non-inferiority compared with insulin glargine U100 for major adverse CV events (MACE). Additionally, the findings for each component of MACE were consistent with the overall endpoint, including the first occurrence of CV death, non-fatal myocardial infarction (MI), or non-fatal stroke.
“The main purpose of the DEVOTE study was to rule out excess cardiovascular risks,” explained Todd Hobbs, MD, chief medical officer, Novo Nordisk US. “If there were any debating or residual questions about cardiovascular risks with Tresiba, these are gone now.”
Results also showed a 40% reduction in the rate of severe hypoglycemia and a 53% reduction in the rate of nocturnal severe hypoglycemia with Tresiba compared to insulin glargine U100. Researchers defined severe hypoglycemia as an episode requiring assistance of another person and nocturnal severe hypoglycemia occurred between the hours of 00:01 and 05:59.
“Previous data hints or suggests that there is a reduction in hypoglycemia with Tresiba but until this point, it has been challenging to prove,” Hobbs said. “With a 40% reduction in overall severe hypoglycemia and 53% reduction in severe hypoglycemia at night time, these episodes can be more clearly related to costs in the healthcare system regarding falls and ER visits and this is important information for anyone making a formulary decision that could impact many lives.”
Post hoc analyses showed similar levels of glycemic control with an end of trial hemoglobin A1c estimated treatment difference of 0.01% between the 2 treatment groups and significantly lower fasting plasma glucose levels with Tresiba after 2 years compared to insulin glargine U100 with an estimated treatment difference of -7.2 mg/dL.
In the DEVOTE study, adverse events leading to permanent discontinuation of the investigational product occurred in 5.2% of patients receiving Tresiba and 5.8% of patients receiving insulin glargine U100.
Common side effects associated with the use of Tresiba include injection site reactions, itching, rash, serious allergic reactions, weight gain, and swelling of hands or feet.