It's Personal: EASD Focuses on Individualizing Diabetes Care

Miriam E. Tucker

September 24, 2018

The European Association for the Study of Diabetes (EASD) 2018 Annual Meeting will offer clinicians a great deal of information to help advance the goal of personalizing treatment for patients with diabetes. 

The meeting, taking place Tuesday, October 1, through Friday, October 5, in Berlin, Germany, will feature new data from at least eight major clinical trials addressing treatment or prevention of type 1 and type 2 diabetes, along with the final version of the 2018 joint Management of Hyperglycemia in Type 2 Diabetes consensus statement by the EASD and ADA, which was previewed in June at the American Diabetes Association (ADA) 2018 Scientific Sessions.

"We're really looking at a new age of pharmacologic treatment of type 2 diabetes...I'm so enthusiastic about the opportunity we have now of so many different options that may be much better suited to one type of patient more than another," program chair Francesco Beguinot, MD, PhD, professor of clinical pathology at Federico II University, Naples, Italy, told Medscape Medical News.

Also on the program will be four prize lectures, 48 oral abstract sessions, over 2000 posters, and dozens of cutting-edge sessions addressing hot topics in both basic and clinical science.

New this year is the live-demonstration EASD e-Learning program. And successful programs for younger members from last year's meeting will continue this year, including the EASD Young Academy, Rising Star Symposium, and European Foundation for the Study of Diabetes (EFSD) mentorship program. 

EASD president Juleen R. Zierath, PhD, professor of physiology at the Karolinska Institute, Stockholm, Sweden, told Medscape Medical News: "The meeting is an incredible place for people to come together to meet other opinion leaders and colleagues. Hopefully you will come away with new knowledge, something that you didn't expect to learn, and this meeting will increase your awareness of the unexpected."

Major Trials Will Inform Clinical Practice

The first of the major clinical trial sessions, taking place on Tuesday at noon, is a bit unusual because the company, GlaxoSmithKline, pulled their drug, the once-weekly injectable glucagonlike peptide 1 (GLP-1) receptor agonist albiglutide (Tanzeum/Eperzan), off the market in July 2018 for financial reasons. It had been available since 2014 in the United States and European Union.

Nonetheless, the 1-hour session will cover glycemic, cardiovascular, renal, and safety results from the phase 3 HARMONY cardiovascular outcomes clinical trial program, which includes more than 5000 patients with type 2 diabetes.

"The drug has been discontinued, but the study will provide important information about the entire class," Beguinot said.

On Wednesday morning, new findings will be presented from the Restoring Insulin Secretion (RISE) Pediatric Medication Study of adolescents with prediabetes or new-onset type 2 diabetes. Data from RISE presented at the American Diabetes Association (ADA) 2018 Scientific Sessions revealed early intervention with long-acting insulin followed by metformin, or metformin alone, failed to prevent beta-cell function deterioration after a year in this patient group.

At EASD, investigators will present more results on outcomes from RISE, as well as the effect of metformin or gastric banding on beta-cell function in the teens.

"Obesity is dramatically increasing in young people and becoming a major determinant of diabetes in youth," Beguinot said. "This is not a US phenomenon. It's seen in Europe and in Asian countries as well, unfortunately," she added.

A session on Wednesday afternoon will cover the PIONEER trial of a first-in-kind oral GLP-1 receptor agonist, semaglutide, which is already available as a once-weekly injectable (Ozempic, Novo Nordisk).

Following the first phase 3 data presented in a late-breaker poster at ADA, the PIONEER presentation at EASD will include more detailed information about how the oral peptide was developed.

"I think this is revolutionary because as an oral treatment it would really widen the use of this class of drug," Beguinot said.

Thursday morning kicks off early with two major clinical trial sessions. One will cover the latest findings from AstraZeneca's observational Comparative Effectiveness of Cardiovascular Outcomes in New Users of SGLT2 Inhibitors (CVD-REAL) studies

This two-part trial has provoked debate, with some arguing that the purported findings of a primary prevention benefit for SGLT2 inhibitors — that they protect against cardiovascular death in patients with type 2 diabetes with no history of cardiovascular disease or any risk factors for it — is too good to be true.

At EASD, the 90-minute session will cover primary and secondary findings, and a summary of clinical implications.    

"This is a huge study of [400,000] patients in 12 countries. Once again, we’ll get information on how our treatments affect patients. The SGLT2 inhibitors are relatively new drugs, so we need to know the effects on cardiovascular outcomes and mortality. This is very important," Beguinot commented.

At the same time on Thursday morning, a session will be devoted to Boehringer Ingelheim's international phase 3 trial of the use of the SGLT2 inhibitor empagliflozin (Jardiance) as adjunct to insulin in patients with type 1 diabetes, the Empagliflozin as Adjunctive to Insulin Therapy Over 52 Weeks in Patients With Type 1 Diabetes Mellitus (EASE) study.

If successful, the results could lead to significant reductions in insulin requirements, which is especially important as obesity and cardiovascular disease are issues in type 1 diabetes as well as type 2 diabetes, Beguinot pointed out.

Mid-day Thursday, metabolic results will be presented from Eisai's CAMELLIA-TIMI 61 trial of its obesity drug, lorcaserin (Belviq).

Cardiovascular safety data from the study were presented at the European Society of Cardiology (ESC) 2018 Congress in Munich in August and showed that lorcaserin, added to diet and exercise, led to modest weight loss compared with placebo and did not increase the risk for major adverse cardiovascular events in 12,000 patients who were overweight or obese and had established cardiovascular disease, type 2 diabetes, or cardiovascular risk factors, for a median of 3.3 years.

If the results show lorcaserin is of benefit in treating type 2 diabetes, it would be "an important and novel addition," Beguinot said.  

Thursday evening, results will be presented from Boehringer Ingelheim's multinational Cardiovascular and Renal Microvascular Outcome Study with Linagliptin in Patients with Type 2 Diabetes Mellitus (CARMELINA), which involves more than 7000 patients with type 2 diabetes at high vascular risk.

Linagliptin (Tradjenta) is a dipeptidyl peptidase-4 (DPP-4) inhibitor, a slightly older class than the GLP-1 receptor agonists and SGLT2 inhibitors, but this type of cardiovascular outcomes data are still needed, Beguinot observed.

"We do very much need this information. Once we have it, we will be in a much better position to move towards more personalized medicine."

The final major trial session on Friday morning will include results from the large EU Prevention of Diabetes Through Lifestyle Intervention and Population Studies in Europe and Around the World (PREVIEW) project.

With 2500 participants, the 3-year randomized trial is larger than the US Diabetes Prevention Program, Beguinot notes.

ADA/EASD Consensus Report: Final Version  

Also on Friday morning, the final version of Management of Hyperglycaemia in Type 2 Diabetes: ADA/EASD Consensus Report 2018 will be presented and discussed.

During a preview of the document at the ADA meeting, clinicians were urged to assess cardiovascular disease status, other comorbidities, and patient preference to personalize the treatment of type 2 diabetes.

The final version, which will be simultaneously published in Diabetologia and Diabetes Care, is not expected to have substantially changed from the draft, but "consensus is very important from a political perspective," Beguinot said.

"Publication will widen access of the information. The participants have worked so hard on this...Consensus is an important advancement itself."

Prize Lectures, Reaching Out to Young Members, e-Learning

Prize lectures this year include the Claude Bernard Lecture by the pre-eminent Finnish diabetes researcher Jaakko Tuomilehto, MD, PhD, University of Helsinki, Finland, who will address Prevention of Type 2 Diabetes: The Dream That Came True; the Camillo Golgi Lecture by Peter Nawroth, MD, University Hospital Heidelberg, Germany, on Diabetic Complications — An Alternative View on Diabetes; and the Minkowski Lecture by Fredrik Bäckhed, PhD, University of Gothenburg, Sweden, on The Gut Microbiota — A Forgotten Organ That Contributes to Glucose Metabolism.

According to Zierath, the prize lectures "are a great place for people to get a snapshot of high-level research in diabetes care."

To further engage young clinicians and researchers, this will be the second year for the EASD Young Academy. It will include six sessions covering diabetes technology, clinical trials in diabetes, career development and funding in the diabetes sector, multidatabase research and data evaluation, and nutrition and epidemiology in diabetes, as well as a scientific publications session with the editor of Diabetologia.

The sessions are only open to members who are PhD candidates (at least third-year), postdocs (less than 5 years), or MDs (less than 7 years), and who do not yet have a faculty appointment. "We put a big focus on young people," Zierath noted.  

In one more nod to young members, the Rising Star Symposium on Tuesday afternoon will feature four up-and-coming scientists who will present their work on topics including brown adipose tissue, genes involved in beta-cell dysfunction, beta-cell regeneration/transplantation, and examining insulin granules to understand type 2 diabetes.

"What's really neat about the rising star lectures is that people who have started to establish themselves as independent investigators are acknowledged at an early stage for their contributions...It's kind of a boost and an affirmation," said Zierath.

The EFSD mentorship program, in conjunction with AstraZeneca, will continue this year with a session on Wednesday afternoon in which the four 2017 mentees will present their projects and the new 2018 mentees will be inaugurated into the program.

New this year will be the launch of EASD's e-Learning modules, which according to the program, "is designed to afford participants to self-direct the way they learn...Participants create their own learning pathways within the modules, guided by opportunities for self-reflection, assessment, and feedback."

The first three e-learning modules, presented in 2-hour live meeting sessions on Diabetes and Ramadan, SGLT2 inhibitors, and Diabetes and Pregnancy, will take place on Tuesday, Wednesday, and Thursday, respectively.

The modules will also be available free on the EASD website after the meeting, and EASD aims to expand the options to 10 to 12 separate modules.

"Wherever you are in the world, you can participate in an e-learning session. We've never done this before. I think it's really exciting...This is a way to impact many, many more people. We hope it has an outcome that influences the way healthcare practitioners manage and care for people who live with diabetes," Zierath said.

And speaking of making an impact, the meeting will be Zierath's last of her 3-year EASD presidency. "It has been a very exciting journey, but I think it's important that organizations have fresh leadership...I've had a lot of fun, but at the same time it's important for others to take the baton," she said.

Beguinot and Zierath have reported no relevant financial relationships.

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