June 12, 2017
HCA Midwest Health, Kansas City’s leading healthcare provider, announces that Dr. Steven Marso, M.D., a renowned experienced interventional cardiologist who has dedicated his career to improving the health of patients with diabetes and heart disease, presented results of a major study today during the American Diabetes 77th Scientific Sessions® in San Diego, the world’s largest scientific meeting focused on diabetes research, prevention and care. Marso is Medical Director of Cardiovascular Services at HCA Midwest Health and oversees the health network’s robust cardiovascular services throughout its Kansas City-area hospitals.
Marso, Study Chairman, along with Vice-Chair Dr. John Buse, M.D., PhD, director of the Diabetes Center, Director of the North Carolina Translational and Clinical Sciences Institute at the University of North Carolina in Chapel Hill, North Carolina, introduced findings of a new, ultra-long acting insulin product, insulin degludec (brand product name is Tresiba®), which has comparable cardiovascular safety to insulin glargine U100 and is also associated with significant reductions in severe hypoglycemia. Marso and Buse presented during a symposium titled “Cardiovascular Safety of Insulin Degludec vs. Insulin Glargine in Patients with Type 2 Diabetes at High Risk of Cardiovascular Events (DEVOTE) Trial Results.’
The Phase 3, multi-center, international, randomized, double-blind DEVOTE study was designed to evaluate the relative cardiovascular safety of insulin degludec (IDeg) compared to insulin glargine (IGlar) U100 when added to a standard of care regimen for people with type 2 diabetes. IDeg is a new generation, once-daily, injectable basal insulin that provides duration of action of at least 42 hours. IGlar is the most commonly prescribed insulin product for people with type 2 diabetes, and its cardiovascular safety was established through the ORIGIN trial published in 2012.
The DEVOTE trial evaluated 7,637 people with type 2 diabetes who were at high risk of major adverse cardiovascular events (MACE), for a period of approximately two years. The study enrolled patients between October 2013 and November 2014 at 436 sites in 20 countries. Of the study participants, 6,506 had prior cardiovascular disease or chronic kidney disease, and the remainder had multiple cardiovascular risk factors. All of the patients were randomized to receive either injectable daily IDeg or IGlar, in addition to the other medications the patients were already taking. However, neither the patient nor the provider knew which insulin formulation they were receiving/giving, which allowed for a robust exploration of safety and efficacy and is unique for insulin comparative studies. The study confirmed the cardiovascular safety of IDeg compared to IGlar U100 by demonstrating non-inferiority of MACE, such as first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke, occurring with a hazard ratio of 0.91 in favor of IDeg relative to IGlar, with no statistically significant difference between the two treatments.
The findings of the DEVOTE trial also demonstrated the hypoglycemic benefit of IDeg. Severe hypoglycemia remains the most serious treatment risk related to insulin therapy, and prior trials have suggested that IDeg is associated with a lower risk of hypoglycemia than IGlar U100, likely related to IDeg’s longer and more consistent insulin action over time.
IDeg resulted in 27 percent fewer patients experiencing an episode of severe hypoglycemia (hypoglycemia requiring the assistance of another person) and a 40 percent overall reduction of total episodes of severe hypoglycemia. Patients in the IDeg-treated group also experienced a 53 percent. IDeg-treated group also experienced a 53 percent relative reduction in the rate of nocturnal severe hypoglycemia, which is a common and serious side effect of insulin therapy. All severe hypoglycemic events of the study participants during the trial period were evaluated and confirmed by a group of external experts, and the differences were all statistically significant.
“The findings of the DEVOTE study are in line with previous clinical trials comparing insulin degludec to insulin glargine U100, so we are pleased to be able to provide conclusive evidence regarding the safety of insulin degludec for patients with type 2 diabetes who are at high risk of cardiovascular complications,” Marso says. “Since insulin degludec also demonstrated significant reductions of severe hypoglycemia, there may be a potential association between severe hypoglycemia and cardiovascular events, which merits further research in future studies.”
“These results will provide reassurance for both people with type 2 diabetes and their healthcare providers that this new insulin product has comparable cardiovascular safety to IGlar,” Buse says. “It is exciting that with IDeg, patients can achieve positive glycemic control along with a major reduction in the risk of severe hypoglycemia, particularly nocturnal severe hypoglycemia.”
“Dr. Marso is a well-regarded specialist and expert who works with patients suffering from complex, advanced heart disease who have been given little hope for survival and offering them new options,” says HCA Midwest Chief Medical Officer Darryl K. Nelson, M.D. “His career and research experience shows his passion for clinical excellence and studies like DEVOTE exemplify his commitment to improve patient outcomes.”
The study will be simultaneously published in the New England Journal of Medicine. For more information on HCA Midwest’s spectrum of cardiovascular services for comprehensive treatment for a wide range of heart conditions, visit our heart care page.