At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Study of Hypercortisolism in Patients With Difficult to Control Type 2 Diabetes Despite Receiving Standard-of-Care Therapies: Prevalence and Treatment With Korlym® (Mifepristone) (CATALYST)
In Brief
A Phase 4 clinical trial evaluating Mifepristone 300 MG [Korlym] and Placebo for mifepristone for Hypercortisolism and Diabetes Mellitus, Type 2. Completed, enrolled 1,113 participants across 36 sites.
Detailed Summary
This is a Phase 4 study with 2 parts: Part 1 (Prevalence Phase) is non-interventional and will assess the prevalence of hypercortisolism in a population with difficult to control type 2 diabetes (T2D) (hemoglobin A1c ≥7.5%) despite receiving standard-of-care therapies. Part 2 (Treatment Phase) 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 T2D despite receiving standard of care therapies.
Study Details
Timeline
Interventions
Mifepristone tablets for once daily oral dosing
Placebo tablets for once daily oral dosing