ADA: Two Big Trials and Special 75th Anniversary Celebration

Miriam E Tucker

June 01, 2015

Results from two major cardiovascular safety trials of diabetes drugs will make headlines at the American Diabetes Association (ADA) 2015 Scientific Sessions, which will also feature a wide range of cutting-edge science, state-of-the-art information, and a celebratory look back.

The conference runs from June 5 to June 9, 2015 in Boston, Massachusetts. The first ADA annual meeting (now called Scientific Sessions) was held June 1, 1941.

"The association was founded during World War II, when the whole world was rumbling. On the brink of disaster, a group of foresighted people decided to declare another kind of war, on diabetes. It must have taken courage and focus to do that. So, we'll pay tribute to the founders of the association," ADA science and medicine president Samuel Dagogo-Jack, MD, told Medscape Medical News.

The conference will offer new research in basic, clinical, and translational science presented in oral abstract and poster sessions, along with symposia, and meet-the-expert and "current-issue" sessions on everything from complications to therapeutics to behavior to epidemiology to genetics and more.

"I would really like to emphasize the comprehensive nature of the 75th Scientific Sessions of the ADA," Dr. Dagogo-Jack said.

TECOS and ELIXA to Be Presented Monday, June 8

The two big trials, Evaluation of Cardiovascular Outcomes in Patients With Type 2 Diabetes After Acute Coronary Syndrome During Treatment With Lixisenatide (ELIXA) and the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS), will be presented one after the other on Monday, June 8.

Top-line results showing noninferiority with placebo have already been announced for both trials — by Sanofi for ELIXA in March and by Merck for TECOS in April — but the ADA sessions will provide the full details.

The TECOS trial in particular is expected to draw a crowd, since it involves a widely used dipeptidyl peptidase-4 (DPP-4) inhibitor diabetes drug, sitagliptin (Januvia, Merck), and will address a concern about possible heart-failure risk raised by previous trials of two other DPP-4 inhibitors. (According to the April Merck statement, there was no increase in hospitalization for heart failure with sitagliptin.)

"Everyone's been waiting to see if this is a drug-class side effect that's been lurking in the weeds," Scientific Sessions Meeting Planning Committee chair David A D'Alessio, MD, told Medscape Medical News.

The ELIXA trial is also likely to generate interest, both for the cardiovascular-end-point data as well as whether any signal for pancreatitis is seen. And although lixisenatide is not yet available in the United States, ELIXA will be the first CVD-outcomes data of any glucagonlike peptide-1 (GLP-1) receptor agonist drug to be released following the US Food and Drug Administration's 2008 requirement of such data for all diabetes drugs.

"I think both of these trials will be viewed with some interest," Dr D'Alessio said.

Presidents' Picks

Of the thousands of research abstracts being presented at the meeting, just six were selected for oral presentation on Tuesday morning in the ADA Presidents' Oral Session, comoderated by Dr Dagogo-Jack and ADA's health care and education president David G Marrero, PhD.

The two clinical papers in the group will examine the impact of food insecurity on glycemic control and dietary habits in low-income Latinos with type 2 diabetes and a comparison of dual- vs single-hormone artificial pancreas systems in patients with type 1 diabetes.

The question of whether glucagon is necessary in addition to insulin for the development of a closed-loop artificial pancreas is a hot topic, Dr D'Alessio noted.

"The addition of glucagon is interesting.…My view a year ago was that it just made things more complicated. But what I've learned from colleagues is that it provides a great buffer against hypoglycemia.…The people who have done that trial have said it's advantageous. To me, it's an interesting question whether bihormonal is anything more than just a flashy idea or it truly gives less hypoglycemia," he said.

Also on the agenda for the Presidents' Oral Session are two papers related to stem cells and insulin resistance, one on mechanisms of acute dysglycemic brain dysfunction in type 1 diabetes, and a mouse study on enhancing insulin secretion.

Diabetes Control in the Real World Dependent on Patient

Dr Dagogo-Jack said that this year's behavioral track is particularly strong, including sessions on the use of technology for behavior change, engaging the "challenging patient," and overcoming barriers to self-management.

"In no other area of medicine is success so dependent on the behavior of the patient than diabetes," he said, noting that more than half of patients with diabetes still don't meet recommended targets for glycemia and other cardiometabolic risk markers.

"Unlike other conditions like infectious diseases, the best physician's efforts will come to naught if the patient is not motivated to comply with recommended standards.…If we can maintain a grip on behavioral determinants of adherence, more than half the battle will be won. So, the ADA dutifully and judiciously focuses on behavioral medicine at this meeting," Dr Dagogo-Jack told Medscape Medical News.

And Dr D'Alessio pointed to several symposia that will examine new ways of delivering care to the growing number of people with diabetes, including innovations in diabetes education and in reaching the underserved and in coordinating care in diverse settings.

"If 10% of the population is going to have diabetes, the old model of people coming in and sitting in waiting rooms one at a time for their diabetes care may not be effective," he said, noting that alternatives such as use of telemedicine consultation or having physician extenders call the patient every few weeks are being explored as potential ways to lower costs and improve outcomes.

Looking Backward and Forward

Just as it does every year, most of the research being presented will build on previous work.

"It's only through the accrual of incremental science that we get a breakthrough. Seldom would somebody wake up and suddenly find a cure. It's always a buildup. So this meeting celebrates the significant buildup of the previous 75 years of work," said Dr Dagogo-Jack.

That celebration will include a special session on June 9 examining the past 50 years of diabetes research and treatment and Dr Dagogo-Jack's presidential address on June 7 entitled, "75 Years of Battling Diabetes — Our Global Challenge."

"My lecture will emphasize the importance of global collaboration and cooperation in diabetes. Nobody knows from which continent the cure for diabetes will come, but we do know that it will be discovered by human beings researching in labs.…At no time has the opportunity for global collaboration been better than now, and at no time [has] sharing the results of research been faster and more instantaneous."

Dr Dagogo-Jack has received research grants from AstraZeneca, Novo Nordisk, and Boehringer Ingelheim and is a consultant for Merck, Novo Nordisk, and Janssen. Dr D'Alessio consults for Janssen, Lilly, Novo Nordisk, Merck, and Intarcia.

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