Nearly 1 in 4 people with type 2 diabetes has Cushing’s syndrome
Researchers said data suggest hypercortisolism as driver of disease
Nearly one out of four people with difficult-to-treat type 2 diabetes also has Cushing’s syndrome, according to preliminary data from the Phase 4 CATALYST clinical trial.
“These results are very powerful,” Ralph DeFronzo, MD, an investigator on the CATALYST study and professor of medicine at UT Health San Antonio, said in a company press release. “We look forward to seeing the full results of this study, as they will guide physicians to better identify patients with hypercortisolism and make informed treatment decisions to prevent the serious and deadly complications associated with the disease.”
Cushing’s syndrome is a general term that refers to disorders driven by excess levels of the stress hormone cortisol, also known as hypercortisolism. High blood sugar and diabetes are relatively common Cushing’s complications, but the new findings suggest cortisol may be an under-recognized driver of diabetes.
“While cortisol’s role in diabetes is well understood, most diabetes care providers have not considered hypercortisolism as a source of the disease for their patients with difficult-to-control diabetes,” DeFronzo said. “These preliminary results clearly indicate that hypercortisolism should be considered — as the prevalence rate is significantly higher than previously assumed.”
Details of CATALYST study of diabetes
The two-part CATALYST trial (NCT05772169) aims to enroll up to 1,000 people with hard-to-treat type 2 diabetes. As of January, the trial was still recruiting participants at a number of sites across the U.S. Participants who have been previously diagnosed with Cushing’s syndrome aren’t eligible.
The first part of the study seeks to assess how many of these diabetes patients have cortisol levels high enough to meet the diagnostic criteria for Cushing’s syndrome. So far, out of the 700 patients enrolled, nearly a quarter (24%) have Cushing’s syndrome, according to preliminary data announced by Corcept Therapeutics, the company sponsoring CATALYST.
Patients with Cushing’s can choose to enroll in the second part of the study, which will assess the safety and efficacy of Corcept’s Korlym (mifepristone) — an approved treatment to manage high blood sugar in certain adults with Cushing’s syndrome and type 2 diabetes or glucose intolerance — against a placebo.
“Almost all of the patients identified as suffering from hypercortisolism currently go undiagnosed,” said Bill Guyer, Corcept’s chief development officer. “We expect that CATALYST’s findings will lead to more accurate diagnoses — and ultimately treatment — for this vulnerable population.”
The full results from the first part will be presented in June at a meeting of the American Diabetes Association, according to Corcept.
“We look forward to advancing this landmark study to completion,” Guyer said. “We deeply appreciate the investigators and patients participating in CATALYST.”
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