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

February 22, 2024 updated by: Corcept Therapeutics

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)

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a Phase 4 study with 2 parts at approximately 30 sites in the United States (US).

Part 1 (Prevalence Phase) is non-interventional and will assess the prevalence of hypercortisolism in a population with difficult to control T2D (HbA1c ≥7.5%) despite receiving standard-of-care therapies.

Patients from Part 1 Prevalence Phase who meet eligibility requirements can then enroll in Part 2 and will be randomized 2:1 to receive mifepristone or placebo once daily with food. Randomization will be stratified by presence of adenoma (yes/no).

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 Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Escondido, California, United States, 92025
        • Recruiting
        • Site 407
      • Gardena, California, United States, 90247
        • Recruiting
        • Site 379
      • Huntington Park, California, United States, 90255
        • Recruiting
        • Site 378
      • La Jolla, California, United States, 92037
        • Recruiting
        • Site 406
      • Los Angeles, California, United States, 90057
        • Recruiting
        • Site 373
      • Tarzana, California, United States, 91356
        • Recruiting
        • Site 387
      • Torrance, California, United States, 90502
        • Recruiting
        • Site 375
    • Florida
      • Edgewater, Florida, United States, 32132
        • Recruiting
        • Site 444
      • Fort Lauderdale, Florida, United States, 33312
        • Recruiting
        • Site 015
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Recruiting
        • Site 097
      • Atlanta, Georgia, United States, 30303
        • Recruiting
        • Site 009
    • Kentucky
      • Covington, Kentucky, United States, 41011
        • Recruiting
        • Site 046
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Recruiting
        • Site 061
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • Site 377
      • New Orleans, Louisiana, United States, 70121
        • Recruiting
        • Site 205
    • Maryland
      • Baltimore, Maryland, United States, 21239
        • Recruiting
        • Site 410
      • Hyattsville, Maryland, United States, 20782
        • Recruiting
        • Site 394
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Site 067
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • Site 074
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Recruiting
        • Site 371
    • New York
      • Albany, New York, United States, 12208
        • Recruiting
        • Site 070
      • Smithtown, New York, United States, 11787
        • Recruiting
        • Site 411
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Recruiting
        • Site 181
      • Wilmington, North Carolina, United States, 28401
        • Recruiting
        • Site 059
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • Site 436
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Site 042
      • Columbus, Ohio, United States, 43215
        • Recruiting
        • Site 195
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Site 077
    • Oregon
      • Grants Pass, Oregon, United States, 97527
        • Recruiting
        • Site 435
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Site 049
    • Texas
      • Cedar Park, Texas, United States, 78613
        • Recruiting
        • Site 456
      • Dallas, Texas, United States, 75230
        • Recruiting
        • Site 370
      • Lufkin, Texas, United States, 75904
        • Recruiting
        • Site 408
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Site 369
      • San Antonio, Texas, United States, 78207
        • Recruiting
        • Site 054
    • Washington
      • Seattle, Washington, United States, 98108
        • Recruiting
        • Site 405

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mifepristone 300 mg
Patients who meet the entry criteria for the Study C-1073-310 will be randomized to receive 600 mg mifepristone for 24 weeks.
Drug: Mifepristone 300 MG [Korlym]
Mifepristone tablets for once daily oral dosing
Placebo Comparator: Placebo
Patients who meet the entry criteria for the Study C-1073-310 will be randomized to receive placebo for 24 weeks.
Drug: Placebo for mifepristone
Placebo tablets for once daily oral dosing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of Hypercortisolism
Time Frame: Screening
Prevalence (percentage) of patients with hypercortisolism defined by dexamethasone suppression test (DST) >1.8 μg/dL with dexamethasone level ≥140 ng/dL in patients with difficult to control T2D, defined as HbA1c ≥7.5%. despite receiving standard-of-care therapies.
Screening

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of Treatment on Neoplastic Hypercortisolism
Time Frame: Baseline Day 1 to week 24
Change in HbA1c from baseline (at randomization) to 24 weeks in patients with neoplastic hypercortisolism who have difficult to control T2D despite receiving standard of care therapies, treated with mifepristone versus placebo.
Baseline Day 1 to week 24
Effect of Treatment on Non-neoplastic Hypercortisolism
Time Frame: Baseline Day 1 to week 24
Change in HbA1c from baseline (at randomization) to 24 weeks in patients with non-neoplastic hypercortisolism who have difficult to control T2D despite receiving standard of care therapies, treated with mifepristone versus placebo.
Baseline Day 1 to week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corcept Therapeutics

Investigators

  • Study Director: Daniel Einhorn, MD, Corcept Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2023

Primary Completion (Estimated)

March 31, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

March 6, 2023

First Submitted That Met QC Criteria

March 6, 2023

First Posted (Actual)

March 16, 2023

Study Record Updates

Last Update Posted (Actual)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-1073-310

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on Mifepristone 300 MG [Korlym]

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Iran

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe