Study to Determine the Prevalence of Hypercortisolism in Patients With Type 2 Diabetes and Treatment With Korlym® (Mifepristone) (CATALYST)

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.

Timeline

Start

2023-03-31

Primary completion

2024-11-19

Completion

2024-12-18

Publications

• DeFronzo RA, Auchus RJ, Bancos I, Blonde L, Busch RS, Buse JB, Findling JW, Fonseca VA, Frias JP, Hamidi O, Handelsman Y, Pratley RE, Rosenstock J, Tudor IC, Moraitis AG, Einhorn D. Study protocol for a prospective, multicentre study of hypercortisolism in patients with difficult-to-control type 2 diabetes (CATALYST): prevalence and treatment with mifepristone. BMJ Open. 2024 Jul 16;14(7):e081121. doi: 10.1136/bmjopen-2023-081121.

Drugs

Indications