New, Long-Acting Insulin Therapy Demonstrates Cardiovascular Safety and Reduces the Risk of Severe Hypoglycemia

According to international DEVOTE trial including more than 7,600 patients

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Jun 12, 2017, 17:15 ET

SAN DIEGO, June 12, 2017 /PRNewswire-USNewswire/ -- A new, ultra-long acting insulin product, insulin degludec, has comparable cardiovascular safety to insulin glargine U100 and is also associated with significant reductions in severe hypoglycemia, investigators presented during a symposium today, titled "Cardiovascular Safety of Insulin Degludec vs. Insulin Glargine in Patients with Type 2 Diabetes at High Risk of Cardiovascular Events (DEVOTE) Trial Results," at the American Diabetes Association's 77th Scientific Sessions^® at the San Diego Convention Center.

The Phase 3, multi-center, international, randomized, double-blind DEVOTE study was designed to evaluate the relative cardiovascular safety of insulin degludec (IDeg)¹ 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 major adverse cardiac events (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.

Severe hypoglycemia is defined as an episode of low blood glucose which is profound enough that the patient requires assistance from another person in order to recover. It is the most serious acute complication of insulin treatment and can be lead to seizures, coma or even death. IDeg resulted in 27 percent fewer patients experiencing an episode of severe hypoglycemia and a 40 percent overall reduction of total episodes of severe hypoglycemia. Patients in the IDeg-treated group also experienced a 53 percent reduction in the rate of nocturnal severe hypoglycemia. 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," said study investigator Dr. Steven Marso, MD, chief medical officer for HCA Midwest Health cardiovascular services.

"These results will provide reassurance for both people with type 2 diabetes and their health care providers that this new insulin product has comparable cardiovascular safety to IGlar," said study investigator Dr. John Buse, MD, PhD, director of the Diabetes Center, director of the NC Translational and Clinical Sciences Institute, and executive associate dean for clinical research at the University of North Carolina School of Medicine in Chapel Hill. "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."

To speak with Dr. Marso or Dr. Buse, please contact the Association's media relations team on-site at the San Diego Convention Center on June 9-13, by phone at 619-525-6250 or by email at [email protected].

The American Diabetes Association's 77th Scientific Sessions, to be held June 9-13, 2017, at the San Diego Convention Center, is the world's largest scientific meeting focused on diabetes research, prevention and care. During the five-day meeting, health care professionals have exclusive access to more than 2,500 original research presentations, participate in provocative and engaging exchanges with leading diabetes experts, and can earn Continuing Medical Education (CME) or Continuing Education (CE) credits for educational sessions. The program is grouped into eight interest areas: Acute and Chronic Complications; Behavioral Medicine, Clinical Nutrition, Education and Exercise; Clinical Diabetes/Therapeutics; Epidemiology/Genetics; Immunology/Transplantation; Insulin Action/Molecular Metabolism; Integrated Physiology/Obesity; and Islet Biology/Insulin Secretion. Brenda Montgomery, RN, MSHS, CDE, President of Health Care and Education², will deliver her address on Saturday, June 10, and Alvin C. Powers, MD, President of Medicine and Science, will present his address on Sunday, June 11. Eight abstracts were selected by the Scientific Sessions Meeting Planning Committee to be presented on Tuesday, June 13, in the President's Oral Session. These abstracts represent important research being conducted in the field of diabetes today. In total, the 2017 Scientific Sessions includes 378 abstracts in 49 oral sessions; 2,152 poster presentations including 50 moderated poster discussions; and 360 published-only abstracts.

About the American Diabetes Association
More than 29 million Americans have diabetes, and every 23 seconds another person is diagnosed with diabetes. The American Diabetes Association (Association) is the global authority on diabetes and since 1940 has been committed to its mission to prevent and cure diabetes and to improve the lives of all people affected by diabetes. To tackle this global public health crisis, the Association drives discovery in research to treat, manage and prevent all types of diabetes, as well as to search for cures; raises voice to the urgency of the diabetes epidemic; and provides support and advocacy for people living with diabetes, those at risk of developing diabetes and the health care professionals who serve them. For more information, please call the American Diabetes Association at 1-800-DIABETES (1-800-342-2383) or visit diabetes.org. Information from both of these sources is available in English and Spanish. Find us on Facebook (American Diabetes Association), Twitter (@AmDiabetesAssn) and Instagram (@AmDiabetesAssn).

¹ The brand product name for insulin degludec is Tresiba^®.
² Disclosures for Brenda Montgomery. Employer: AstraZeneca Pharmaceuticals. Montgomery's role as President, Health Care & Education of the American Diabetes Association (Association) is a voluntary position to which she was elected by the members of the Association in 2015. She continues to recuse herself from any and all discussions, decisions or votes that have or could be perceived as having a conflict of interest with her employer.

SOURCE American Diabetes Association