SAN FRANCISCO, June 11, 2019 /PRNewswire/ -- For people with type 2 diabetes (T2D) and chronic kidney disease (CKD), canagliflozin, an oral, sodium-glucose co-transporter-2 (SGLT2) inhibitor, has a renal- and cardiovascular-protective effect in reducing the progression of kidney impairment, according to the results of the CREDENCE trial presented today in a symposium at the American Diabetes Association's® (ADA's) 79th Scientific Sessions® at the Moscone Convention Center in San Francisco.

In the first of several renal outcomes studies of SGLT2s, the landmark Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) trial found canagliflozin reduced the risks of kidney failure of death by about 34% compared to placebo. The CREDENCE trial is the first study in 18 years to show a drug can reduce cardiovascular and renal outcomes in people with T2D and CKD, regardless of their previous history of cardiovascular disease (CVD).

"We are excited for our patients about the magnitude of the improvement in kidney and heart outcomes," said co-principal investigator Kenneth Mahaffey, MD, vice chair of clinical research in the department of medicine at Stanford University and the director of the Stanford Center for Clinical Research. "The benefits were consistent in many different subgroups of patients, and this is the first treatment advance for patients with type 2 diabetes and chronic kidney disease in nearly two decades."

The CREDENCE trial is the first of several ongoing outcomes trials in patients with T2D and CKD with SGLT2 inhibitors, a group of glucose-lowering therapies targeting a protein that affects the reuptake of glucose by the kidneys back into the bloodstream. SGLT2 inhibitors rid the body of glucose through urine. This mechanism is different than previous long-term treatments of T2D.

CREDENCE was a randomized, double-blind controlled trial that ended early after a planned interim analysis indicated an overwhelming benefit. At the time of cessation, 4,401 people, with a mean age of 63 years and a T2D average duration of 15.8 years, had enrolled and received follow up for an average 2.62 years. The study participants had HbA1c levels between 6.5%–12%, with an estimated glomerular filtration rate (eGFR) at between 30-90 milliliters/minute/1.73 meters2 (a measurement of kidney function). The participants were assigned to receive either 100mg of oral canagliflozin or a placebo, daily.

CREDENCE researchers focused on progression to end-stage renal disease, the doubling of serum creatinine and renal or cardiovascular (CV) death. The results indicated the canagliflozin group had a lower risk of CV death, myocardial infarction, or stroke (hazard ratio, 0.80; 95% CI, 0.67 to 0.95; P=0.01) and CV death or hospitalization for heart failure (hazard ratio, 0.61; 95% CI, 0.47 to 0.80; P<0.001). The study also showed relative risk of the renal-specific composite of end-stage kidney disease, a doubling of the creatinine level, or death from renal causes was lower in the canagliflozin group by 34% (hazard ratio, 0.66; 95% CI, 0.53 to 0.81; P<0.001). The relative risk of end-stage kidney disease was lower in the canagliflozin group by 32% (hazard ratio, 0.68; 95% CI, 0.54 to 0.86; P=0.002).

"Considering type 2 diabetes is a leading cause of kidney failure, our study of canagliflozin in this patient group achieved the positive outcomes we had hoped for," said co-investigator, Meg Jardine, MBBS, PhD, conjoint associate professor of medicine at the University of New South Wales in Australia, and program head at the George Institute for Global Health. "Patients with type 2 diabetes are already at a high risk for serious kidney or cardiac events. This risk is even higher in those who have chronic kidney disease, and canagliflozin reduces the chance of these events safely and effectively without increasing negative side effects."

To speak with Dr. Mahaffey or Dr. Jardine, please contact the ADA Press Office on-site at San Francisco's Moscone Convention Center on June 7-11, by phone at 415-978-3606 or by email at SciSessionsPress@diabetes.org.

The American Diabetes Association's 79th Scientific Sessions, the world's largest scientific meeting focused on diabetes research, prevention and care, is being held June 7-11, 2019, at the Moscone Center in San Francisco, California. Nearly 15,000 leading physicians, scientists, health care professionals and industry representatives from around the world have convened at the Scientific Sessions to unveil cutting-edge research, treatment recommendations and advances toward a cure for diabetes. During the five-day meeting, attendees receive exclusive access to more than 850 presentations and 2,000 original research presentations, participate in provocative and engaging exchanges with leading diabetes experts, and earn Continuing Medical Education (CME) or Continuing Education (CE) credits for educational sessions. The program is grouped into eight thematic 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. Gretchen Youssef, MS, RDN, CDE, President of Health Care and Education, delivered her address, "It's All about Access!," on Saturday, June 8, and Louis H. Philipson, MD, PhD, FACP, President of Medicine and Science, delivered his lecture, "Precision Medicine—Addressing the Many Faces of Diabetes," on Sunday, June 9. Join the Scientific Sessions conversation on social media using #ADA2019.

About the American Diabetes Association Every day more than 4,000 people are newly diagnosed with diabetes in America. Nearly 115 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). Information is available in English and Spanish. Join the fight with us on Facebook ( American Diabetes Association ), Twitter ( @AmDiabetesAssn ) and Instagram ( @AmDiabetesAssn ).

Press Office in San Francisco June 7-11, 2019 415-978-3606

Contact: Michelle Kirkwood (703) 299-2053 mkirkwood@diabetes.org

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SOURCE American Diabetes Association

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