CHICAGO, June 15, 2020 /PRNewswire/ -- The SGLT2 inhibitor dapagliflozin, when used in patients with heart failure, provided a benefit in preventing type 2 diabetes (T2D), according to the study, "Effect of Dapagliflozin on the Incidence of Diabetes: A Prespecified Exploratory Analysis from DAPA-HF," presented today at the American Diabetes Association's® (ADA's) 80th Virtual Scientific Sessions.
The original DAPA-HF trial was a phase 3 placebo-controlled international study of dapagliflozin in people with chronic heart failure and a reduced ejection fraction (a measurement indicating the percentage of blood the left ventricle of the heart pumps out with each contraction.) The trial enrolled people both with and without type 2 diabetes. The 4,774 study participants, average age 66 years, were randomly assigned to take either 10 mg of dapagliflozin or a placebo once daily and were followed for 18.2 months. The study indicated the risk of worsening heart failure or death from cardiovascular causes was lower among the dapagliflozin patients than among those who received the placebo, regardless of the presence or absence of diabetes.
The current planned analysis assessed whether dapagliflozin reduced the incidence of T2D in the 2,605 trial participants who did not have T2D when the study began. Of the participants without T2D, 1,298 had been assigned to the dapagliflozin group, and 1,307 to the placebo group. New-onset T2D was defined as A1C ≥ 6.5% on two consecutive study visits throughout the median 18.2-month follow-up.
Results of the analysis indicated:
A total of 157 participants developed T2D, 150 of whom had prediabetes (A1C 5.7-6.4%) at the beginning of the study.
The people who developed T2D had higher average A1C levels, greater body mass index (BMI) and lower eGFR (level of kidney function) at the beginning of the study than those who did not develop diabetes.
Cox proportional hazards model data showed dapagliflozin reduced new-onset diabetes by 32%, with 4.9% of dapagliflozin patients (64 of 1,298) developing T2D, compared to 7.1% (93 of 1,307) in the placebo group.
In an additional exploratory analysis, those patients who did develop diabetes during the trial experienced a 70% increase in mortality, after adjustments for baseline features.
"Our sub-study within the DAPA-HF trial demonstrates that diabetes prevention could be considered an additional benefit of dapagliflozin, whose main effect, of course is to reduce cardiovascular mortality and worsening heart failure in patients with heart failure and reduced ejection fraction," said Silvio Inzucchi, MD, lead investigator and professor of medicine at the Yale University School of Medicine. "The 32% relative risk reduction compares favorably with the 31% reduction with metformin, as reported in the Diabetes Prevention Program. We will need to do more studies to see if this effect extends to patients without heart failure and reduced ejection fraction and to evaluate how durable the benefit might be and how long diabetes prevention persists after the discontinuation of therapy."
For more information, or to request an interview with Dr. Inzucchi, please contact Daisy Diaz by phone at (703) 253-4807 or by email at [email protected].
About the ADA's Scientific Sessions The ADA's 80th Scientific Sessions, the world's largest scientific meeting focused on diabetes research, prevention and care, is being held virtually June 12-16, 2020. Leading physicians, scientists and health care professionals from around the world will unveil cutting-edge research, treatment recommendations and advances toward a cure for diabetes. Though the conference will be remote this year, attendees will receive exclusive access to nearly 2,000 original research presentations and take part in provocative and engaging exchanges with leading diabetes experts. Learn more and register at scientificsessions.diabetes.org and join the Scientific Sessions conversation on social media using #ADA2020 and #ADAGoesVirtual.
About the American Diabetes Association Every day more than 4,000 people are newly diagnosed with diabetes in America. More than 122 million Americans have diabetes or prediabetes and are striving to manage their lives while living with the disease. The American Diabetes Association (ADA) is the nation's leading voluntary health organization fighting to bend the curve on the diabetes epidemic and help people living with diabetes thrive. For nearly 80 years the ADA has been driving discovery and research to treat, manage and prevent diabetes, while working relentlessly for a cure. We help people with diabetes thrive by fighting for their rights and developing programs, advocacy and education designed to improve their quality of life. Diabetes has brought us together. What we do next will make us Connected for Life. To learn more or to get involved, visit us at diabetes.org or call 1-800-DIABETES (1-800-342-2383). Join the fight with us on Facebook (American Diabetes Association), Twitter (@AmDiabetesAssn) and Instagram (@AmDiabetesAssn).