Miriam E Tucker

September 10, 2015

STOCKHOLM — Hot topics at the European Association for the Study of Diabetes (EASD) 2015 Meeting will include results of the Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME) study, the much-anticipated cardiovascular-outcomes trial for the sodium-glucose cotransporter 2 (SGLT2) inhibitor empagliflozin (Jardiance, Lilly/Boehringer Ingelheim).

Also featured at the conference, taking place in Stockholm September 15-18, will be key findings for a combination injection product for type 2 diabetes and in-depth discussions of the recently identified diabetic ketoacidosis (DKA) risk with the SGLT2-inhibitor drug class.

Monika Grüsser, EASD managing director and chief medical officer, told Medscape Medical News that EASD has a newly designed virtual meeting site, and the session links have already received thousands of clicks thus far.

Another new addition this year will be follow-up symposia from industry on Thursday night, to recap and add information to the official conference presentations.

"We will have four halls with evening presentations from the companies. It will give attendees the opportunity to hear more about the trials," Dr Grüsser said.

Detailed data from EMPA-REG OUTCOME will be presented Thursday evening, following the August 20 release of positive top-line results from Boehringer Ingelheim and Eli Lilly.

The multicenter randomized trial of more than 7000 adults with type 2 diabetes at high risk for cardiovascular events not only met its primary end point of cardiovascular safety for empagliflozin but also appears to have demonstrated superiority over standard of care in cardiovascular risk reduction, a first for any glucose-lowering agent in a dedicated CV-outcomes trial.

"For the first time it might happen in the history of treatment of type 2 diabetes that cardiac side effects are [reduced] with a glucose-lowering agent. We've only been able to show that diabetes side effects get better....This is very important," Dr Grüsser told Medscape Medical News.

Important Trials Reported Concurrently

As per years past, the meeting organizers have saved other major trial results for the last day, Friday. The bad news is that three of the hottest sessions will take place at the same time, but the good news is that all of them can be watched afterward on the virtual meeting site.

One of the concurrent sessions will feature data from five trials in the DUAL program, on the fixed-dose combination of the ultralong-acting insulin degludec plus the glucagonlike peptide 1 (GLP-1) receptor agonist liraglutide (Xultophy, Novo Nordisk).

"It's a fixed mixture in one syringe, so it's really convenient for patients. They just have to inject it....This is really important and exciting," Dr Grüsser said.

But not everyone agrees. The subject of whether fixed combinations of insulin and GLP agonists are really needed will also be the subject of the Michael Berger debate on Friday morning.

Xultophy is currently available in Switzerland and approved in the member states of the European Union; however, the United States is a no-go for the time being, since the Food and Drug Administration (FDA) has denied approval of one component, insulin degludec, requesting studies with cardiovascular end points. But liraglutide is approved there, both for type 2 diabetes and more recently in a higher dose for obesity.

Insulin degludec is also soon to disappear from the market in Germany due to failed pricing discussions, so it remains to be seen what will happen to Xultophy there.

Also on Friday, back-to-back sessions will provide updates from the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) and the Evaluation of Lixisenatide in Acute Coronary Syndrome (ELIXA) study, both of which were initially presented in June at the American Diabetes Association meeting in Boston.

In TECOS, the use of sitagliptin (Januvia, Merck), a dipeptidyl peptidase-4 (DPP-4) inhibitor, was not associated with an increased risk of cardiovascular events in patients with type 2 diabetes and cardiovascular disease. The study, involving more than 14,000 patients, also found no increased risk for pancreatitis or pancreatic cancer.

In ELIXA, the injectable GLP-1 agonist lixisenatide (Lyxumia, Sanofi) equally did not show any harm in the 6000 high-risk patients with diabetes who had recently suffered an acute coronary event.

Deeper dives into the heart-failure outcomes in the TECOS study and ELIXA trial, both of which showed no increased risk of this outcome with the respective therapies, were recently reported at the European Society of Cardiology Congress in London.

At the EASD meeting, an update of the TECOS safety data will be presented, along with an overview of the study as a whole. Two speakers will give their perspectives on the cardiovascular and glucometabolic aspects of lixisenatide, and the presentation will include new data as well, Dr Grüsser said.

Update on DKA With SGLT2 Inhibitors

The third Friday morning concurrent session may just generate some heat: Entitled "Trending Topics in SGLT2 Inhibition," it will feature an update on  ketoacidosis with SGLT2 inhibitors from Anne Peters, MD, from the Keck School of Medicine, University of Southern California, Los Angeles, California, who has published on the topic, followed by a presentation on the efficacy and safety of canagliflozin (Invokana, Johnson & Johnson/ Janssen) in an 18-week phase 2 study in patients with type 1 diabetes.

Previous company trials have yielded a low (less than 1%) but still slightly elevated risk for DKA with canagliflozin, and at least one expert has advised avoiding SGLT2 inhibitors in patients with type 1 diabetes outside of clinical trials.

On the other hand, others expert have said that the risk can be managed safely.

Of course, these are just a small sampling of all the EASD offerings.

Other Interesting Presentations

Other symposia include the first-ever Novo Nordisk Foundation Diabetes Prize for Excellence lecture on human metabolic disease, lessons learned from genetics, and debates on whether insulin resistance is always bad and whether triple and quadruple therapies are necessary.

There are also intriguing data on older therapies, such as sulfonylureas and whether they still have a role to play, on Wednesday and Thursday, and a whole session on the diabetic foot, on Tuesday, including results from a randomized double-blind study of hyperbaric oxygen therapy.

Diabetes and pregnancy and the long-term implications for children, as well as gestational diabetes, also feature on the menu on Wednesday, as does "Diabetic Pregnancy from A to Z" on Thursday.

Other interesting sessions on Wednesday include the management of cardiovascular risk factors in diabetes, an update on bariatric surgery, and a session on brain reward and satiety.

On Thursday, diabetes and the kidney and "Diabetic Neuropathy From Top to Toe" feature in the program, as does "An Eye on Retinopathy" on Friday morning. The same day sees debate on gut microbiota in a session entitled "Bugs in the Belly."

There are also important sessions throughout the week on the price and logistics of diabetes care and diabetes in the elderly.

And then there are more than 1000 posters on cutting-edge basic and clinical research on a broad range of diabetes-related topics.

A look at visitor traffic to EASD site so far shows there is huge interest in oral and poster abstract sessions on cardiometabolic epidemiology, incretin-based therapy, insulin analogs, future diabetes therapy, and everything to do with SGLT2 inhibitors, Dr Grüsser said.

The meeting officially ends at 14:50 Friday. "You have Friday afternoon to listen to the things you missed," she said.

Dr Grüsser has no relevant financial relationships.

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