Study to Determine the Prevalence of Hypercortisolism in Patients With Type 2 Diabetes and Treatment With Korlym® (Mifepristone) (CATALYST)
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| ClinicalTrials.gov Identifier: NCT05772169 |
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Recruitment Status :
Recruiting
First Posted : March 16, 2023
Last Update Posted : February 26, 2024
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hypercortisolism Diabetes Mellitus, Type 2 | Drug: Mifepristone 300 MG [Korlym] Drug: Placebo for mifepristone | Phase 4 |
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 (Clinical Trial) |
| Estimated Enrollment : | 1000 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Masking Description: | Double Blind |
| Primary Purpose: | Treatment |
| 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) |
| Actual Study Start Date : | March 31, 2023 |
| Estimated Primary Completion Date : | March 31, 2024 |
| Estimated Study Completion Date : | July 2024 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Drug: Mifepristone 300 MG [Korlym]
Mifepristone tablets for once daily oral dosing |
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Placebo Comparator: Placebo
Patients who meet the entry criteria for the Study C-1073-310 will be randomized to receive placebo for 24 weeks.
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Drug: Placebo for mifepristone
Placebo tablets for once daily oral dosing |
- 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.
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05772169
| Contact: Clinical Trial Lead | 650-688-2858 | corceptstudy310@corcept.com |
Show 36 study locations
| Study Director: | Daniel Einhorn, MD | Corcept Therapeutics |
| Responsible Party: | Corcept Therapeutics |
| ClinicalTrials.gov Identifier: | NCT05772169 |
| Other Study ID Numbers: |
C-1073-310 |
| First Posted: | March 16, 2023 Key Record Dates |
| Last Update Posted: | February 26, 2024 |
| Last Verified: | February 2024 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Hypercortisolism Diabetes Mellitus, Type 2 Uncontrolled |
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Diabetes Mellitus Diabetes Mellitus, Type 2 Cushing Syndrome Adrenocortical Hyperfunction Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Adrenal Gland Diseases Mifepristone Abortifacient Agents, Steroidal Abortifacient Agents Reproductive Control Agents |
Physiological Effects of Drugs Contraceptives, Oral, Synthetic Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Contraceptives, Postcoital, Synthetic Contraceptives, Postcoital Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Luteolytic Agents Contraceptive Agents, Hormonal Menstruation-Inducing Agents |