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

• Status: Not yet recruiting
• Trial end date: 2024-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Corcept Therapeutics
• Treatments: Mifepristone

Criteria

Inclusion Criteria:

• Has difficult to control T2D (HbA1c ≥7.5% and ≤11.5%) based on HbA1c performed at screening.

AND Taking 3 or more anti-hyperglycemic drugs. OR Taking insulin and other anti-hyperglycemic drugs. OR Taking 2 or more anti-hyperglycemic drugs AND a.) the presence of 1 or more micro-vascular or macro-vascular complication (retinopathy, diabetic nephropathy and chronic kidney disease, diabetic neuropathy, atherosclerotic heart disease with diabetes); AND/OR b.) concomitant hypertension requiring 2 or more anti-hypertension medications.

Exclusion Criteria:

• Has type 1 diabetes mellitus.

• New-onset diabetes less than 1 year.

• Systemic glucocorticoid medications exposure (excluding inhalers or topical) within 3 months of screening.

• Is pregnant or lactating. For women of childbearing potential, have a positive pregnancy test before dexamethasone administration. A woman of childbearing potential includes all women <50 years old, women whose surgical sterilization was performed <6 months ago, and women who have had a menstrual period in the last 12 months.

• On hemodialysis or has end-stage renal disease.

• Has severe untreated sleep apnea as judged by the Investigator.

• Has excessive alcohol consumption (>14 units/week for male, >7 units/week for female) as judged by the Investigator.

• Has severe psychiatric illness by history (such as schizophrenia or dementia) as judged by the Investigator.

• Has severe medical or surgical illness as judged by the Investigator.

• Is a night shift worker, i.e., is awake from approximately 11 PM to 7 AM.

• Has taken any investigational drug within 4 weeks prior to screening, or within less than 5 times the drug's half-life, whichever is longer.

• Has had the diagnosis of Cushing syndrome or has used or plans to use any of the following treatments for Cushing syndrome:

• Mifepristone, metyrapone, osilodrostat, ketoconazole, fluconazole, aminoglutethimide, etomidate, octreotide, larazotide, pasireotide, long-acting octreotide or pasireotide.

• Has a history of hypersensitivity or severe reaction to dexamethasone