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

Primary Purpose

Hypercortisolism, Diabetes Mellitus, Type 2

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Mifepristone 300 MG [Korlym]
Placebo for mifepristone
Sponsored by
Corcept Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercortisolism focused on measuring Hypercortisolism, Diabetes Mellitus, Type 2 Uncontrolled

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Site 407Recruiting
  • Site 379Recruiting
  • Site 378Recruiting
  • Site 406Recruiting
  • Site 373Recruiting
  • Site 387Recruiting
  • Site 375Recruiting
  • Site 015Recruiting
  • Site 097Recruiting
  • Site 046Recruiting
  • Site 061Recruiting
  • Site 377Recruiting
  • Site 205Recruiting
  • Site 410Recruiting
  • Site 394Recruiting
  • Site 067Recruiting
  • Site 074Recruiting
  • Site 371Recruiting
  • Site 070Recruiting
  • Site 411Recruiting
  • Site 181Recruiting
  • Site 042Recruiting
  • Site 195Recruiting
  • Site 049Recruiting
  • Site 370Recruiting
  • Site 408Recruiting
  • Site 054Recruiting
  • Site 369Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Mifepristone 300 mg

Placebo

Arm Description

Patients who meet the entry criteria for the Study C-1073-310 will be randomized to receive 600 mg mifepristone for 24 weeks.

Patients who meet the entry criteria for the Study C-1073-310 will be randomized to receive placebo for 24 weeks.

Outcomes

Primary Outcome Measures

Prevalence of Hypercortisolism
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.

Secondary Outcome Measures

Effect of Treatment on Neoplastic Hypercortisolism
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.
Effect of Treatment on Non-neoplastic Hypercortisolism
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.

Full Information

First Posted
March 6, 2023
Last Updated
October 10, 2023
Sponsor
Corcept Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT05772169
Brief Title
Study to Determine the Prevalence of Hypercortisolism in Patients With Type 2 Diabetes and Treatment With Korlym® (Mifepristone) (CATALYST)
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 31, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Corcept Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercortisolism, Diabetes Mellitus, Type 2
Keywords
Hypercortisolism, Diabetes Mellitus, Type 2 Uncontrolled

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Double Blind
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mifepristone 300 mg
Arm Type
Experimental
Arm Description
Patients who meet the entry criteria for the Study C-1073-310 will be randomized to receive 600 mg mifepristone for 24 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients who meet the entry criteria for the Study C-1073-310 will be randomized to receive placebo for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Mifepristone 300 MG [Korlym]
Intervention Description
Mifepristone tablets for once daily oral dosing
Intervention Type
Drug
Intervention Name(s)
Placebo for mifepristone
Intervention Description
Placebo tablets for once daily oral dosing
Primary Outcome Measure Information:
Title
Prevalence of Hypercortisolism
Description
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.
Time Frame
Screening
Secondary Outcome Measure Information:
Title
Effect of Treatment on Neoplastic Hypercortisolism
Description
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.
Time Frame
Baseline Day 1 to week 24
Title
Effect of Treatment on Non-neoplastic Hypercortisolism
Description
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.
Time Frame
Baseline Day 1 to week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trial Lead
Phone
650-688-2858
Email
corceptstudy310@corcept.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Einhorn, MD
Organizational Affiliation
Corcept Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Site 407
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 379
City
Gardena
State/Province
California
ZIP/Postal Code
90247
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 378
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 406
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 373
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 387
City
Tarzana
State/Province
California
ZIP/Postal Code
91356
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 375
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 015
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33312
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 097
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 046
City
Covington
State/Province
Kentucky
ZIP/Postal Code
41011
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 061
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 377
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 205
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 410
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21239
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 394
City
Hyattsville
State/Province
Maryland
ZIP/Postal Code
20782
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 067
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 074
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 371
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 070
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 411
City
Smithtown
State/Province
New York
ZIP/Postal Code
11787
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 181
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 042
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 195
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 049
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 370
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 408
City
Lufkin
State/Province
Texas
ZIP/Postal Code
75904
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 054
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 369
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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