LEADER Trial Leads the Pack at ADA

— But meeting in New Orleans will also feature thousands of new papers

MedpageToday

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NEW ORLEANS -- The results from a cardiovascular safety trial of liraglutide (Victoza) called LEADER will be sitting in the catbird seat at this year's annual meeting of the American Diabetes Association (ADA) -- but it won't be the only headline-grabbing finding reported here during the meeting, which kicks off Thursday.

Drugmaker Novo Nordisk announced earlier this year that liraglutide was associated with reduced risk of cardiovascular disease among patients with type 2 diabetes. This was big news since it was only the second diabetes drug to show a reduced risk -- empagliflozin (Jardiance) claimed that honorific last year. But the results announced were top-line only, and the extent of that benefit is still publicly unknown.

The full results for the glucagon-like peptide-1 (GLP-1) receptor agonist will be announced in a 2-hour session Monday.

The cardiovascular safety trial known as EMPA-REG found that empagliflozin, a sodium glucose co-transporter 2 (SGLT-2) inhibitor, was associated with decreased risk of death from a composite of death from cardiovascular causes, nonfatal myocardial infarction, and nonfatal stroke (hazard ratio 0.86, 95.02% 0.74-0.99; P=0.04).

But at the time of the announcement last year at the annual meeting of the European Association for the Study of Diabetes, researchers hadn't had time to parse a lot of the data and do sub-analyses. And there were questions over the mechanisms by which empagliflozin reduced risk and whether there was a larger class effect at play that would mean other gliflozin drugs could cut cardiovascular risk as well. Researchers will discuss these issues at a separate 2-hour session on Tuesday morning.

The investigational agent, semaglutide, which like liraglutide is also a GLP-1 analogue, was also found to cut cardiovascular risk in a phase IIIa trial reported earlier this year.

Other Research

Desmond Schatz, MD, the president of ADA, said in an email to MedPage Today that he will deliver a "very provocative" talk titled "Diabetes at 212 Degrees: Confronting the Invisible Disease." He said his talk, which is scheduled for Sunday morning, will be a call for action for the estimated 16,000 attendees at this year's meeting.

Schatz said the program features 50 oral sessions and more than 2,000 poster presentations.

Eight of those abstracts have been chosen for a special president's oral session which will mark the ADA's closing session on Tuesday. One of the studies selected for the president's plenary focuses on volume changes in brain gray matter among adolescents with type 2 diabetes. Another is a trial of a closed-loop glucagon administration system for type 1 diabetes abstracts.

Other chosen clinical abstracts include:

  • Novel Genetic Determinants of Diabetic Kidney Disease
  • Diabetes Prevention with Pioglitazone in Insulin Resistant Patients with Cerebrovascular Disease
  • Physical Activity and Diabetes Development: The Diabetes Prevention Program (DPP) Outcomes Study
  • T Cell Mitochondrial Dysfunction in Human Type 1 Diabetes
  • Cumulative Life Stress Is Associated with Islet Autoimmunity in HLA DR3/4 Children

In addition, there will be a late-breaking poster session that includes nearly 350 posters.

In his email, Schatz said he also wanted to highlight the Pathway to Stop Diabetes Symposium on Monday morning, which will feature the work of a handful of researchers funded partly by the Pathway initiative. That research includes updates on how smell impacts metabolism, how genes relate to type 2 diabetes and gestational diabetes, and how hyperglycemia can lead to retinopathy, said Schatz.