The Monday, June 24, session Prevalence of Hypercortisolism in Difficult-to-Control Type 2 Diabetes will feature an expert panel of investigators who will discuss findings from Part 1 of the CATALYST study, which looked at the prevalence of hypercortisolism in patients with difficult-to-control type 2 diabetes (A1C ≥7.5% despite receiving multiple standard-of-care therapies).

The session will take place from 3:15 p.m. – 4:15 p.m. ET in Room W415B, the Valencia Ballroom, of the Orange County Convention Center. It will also be available on-demand on the virtual meeting platform following the 84^th Scientific Sessions for registered participants. 

“It’s been known for some time that excess cortisol from any source is associated with higher blood glucose and difficult-to-control diabetes,” said John B. Buse, MD, PhD, the Verne S. Caviness Distinguished Professor of Medicine, Director of the Diabetes Care Center, and Director of the Translational and Clinical Sciences Institute at the University of North Carolina School of Medicine, who will discuss the clinical implications of Part 1 of the trial.

Hypercortisolism can be the result of the body producing excess cortisol or from people taking steroids as a treatment for conditions such as asthma, Dr. Buse noted. Regardless of the cause, excess steroids can produce multiple medical problems—including cardiovascular disease and metabolic changes—that make blood glucose management difficult.

“Participants in the CATALYST study were screened for the presence of hypercortisolism with the dexamethasone suppression test (DST), which involves taking a 1 mg tablet of dexamethasone at 11 p.m. and doing an 8 a.m. serum cortisol the following morning,” Dr. Buse said. “A normal result is near zero. Any result above 1.8 is considered hypercortisolism. To prevent potential false positives, participants were carefully screened, and their dexamethasone blood levels checked.”

The panel will report on the results of this screening study, including data on the additional lab and imaging results that were found in the people with hypercortisolism, and how they differed from people without hypercortisolism. 

Part 2 of the CATALYST study, which is currently underway, is a randomized, prospective, placebo-controlled, double-blind multi-center trial that will assess the safety and efficacy of mifepristone treatment in patients with hypercortisolism who have difficult-to-control type 2 diabetes.

“Results of the trial will demonstrate that the prevalence of hypercortisolism in this population of over 1,000 people with difficult-to-control diabetes is 25%,” Dr. Buse said. “This prevalence has been consistent since the beginning of the trial. There is value to the patient and the clinician in knowing that there is a reason for the diabetes being difficult to control, rather than it being a matter of lack of adherence or lack of recommending the right treatments.”

Ultimately, the goal is treating the hypercortisolism and making diabetes care easier and better.

“The treatment phase of the study is ongoing and will likely be completed near the end of the year,” Dr. Buse said. “Hopefully, at the Scientific Sessions next year, we will have an even better idea of what to tell people with regards to both screening and treatment for hypercortisolism when they have diabetes that is difficult to control.”

Vivian Fonseca, MD, Tulane University School of Medicine, will provide additional insights into the results of Part 1 of the trial. Athena Philis-Tsimikas, MD, Scripps Whittier Diabetes Institute, Scripps Health, will discuss the rationale and design of CATALYST.

Richard Auchus, MD, PhD, University of Michigan, will discuss the spectrum of hypercortisolism. Ralph A. DeFronzo, MD, University Texas Health Science Center at San Antonio, will give an overview of the pathologic mechanisms of the condition.