CATALYST: Hypercortisolism prevalence high with difficult-to-treat type 2 diabetes
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Key takeaways:
- Part one of the CATALYST study assesses the prevalence of hypercortisolism among adults with difficult-to-control type 2 diabetes.
- Of the first 700 people to enroll, 24% have hypercortisolism.
Hypercortisolism is prevalent among nearly one-quarter of people with difficult-to-control type 2 diabetes enrolled in a prospective phase 4 study, according to an industry press release.
Preliminary results from the prevalence phase of the CATALYST study were released by Corcept Therapeutics on Feb. 15. CATALYST is a two-part study enrolling adults with difficult-to-control type 2 diabetes, defined as having an HbA1c of more than 7.5% despite receiving optimal therapies. The first part of the trial will assess the prevalence of hypercortisolism among study participants. Hypercortisolism is defined as having a dexamethasone suppression test value of more than 1.8 g/dL and a dexamethasone level of more than 140 ng/dL.
Among the first 700 people enrolled in the trial, 24% had hypercortisolism. The prevalence rate has remained consistent throughout the trial, which will eventually enroll 1,000 participants, according to the release.
“These results are very powerful. 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,” Ralph DeFronzo, MD, chief of the diabetes division and professor of medicine at UT Health San Antonio, and CATALYST study investigator, said in the release. “These preliminary results clearly indicate that hypercortisolism should be considered — as the prevalence rate is significantly higher than previously assumed. 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.”
Participants in part one of CATALYST who meet additional screening criteria will be eligible to continue to the treatment portion of the trial. In part two, participants will be randomly assigned, 2:1, to receive either mifepristone (Korlym, Corcept Therapeutics) or placebo.
Final results from the prevalence phase of CATALYST will be presented at the American Diabetes Association Scientific Sessions in June, according to the release.
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