Diabetes Mellitus, Type 2 Clinical Trial
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)
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.
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | July 2024 |
Est. primary completion date | May 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | For Part 1: 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. • Women on oral contraceptive pills (OCPs) may be screened but must be willing and able to stop OCPs for at least 3 weeks prior to the dexamethasone suppression test. 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 For Part 2: Inclusion Criteria: - Has completed Part 1 of the study with post-DST cortisol level of >1.8 µg/dL and dexamethasone level =140 ng/dL - Will have no change in, or initiation of, diabetes medications within 4 weeks prior to first study drug dose Exclusion Criteria: - Has any change in status of exclusion criteria from Part 1 - Requires inhaled glucocorticoid use and may require systemic glucocorticoids if their condition deteriorates during study - Has severe, poorly controlled hypertension at screening (defined as mean systolic BP >160 mmHg or mean diastolic BP >100 mmHg); must be able to correct to a BP of <160/100 mmHg before first dose of study drug - Has refractory hypokalemia; must be able to correct to potassium level of =4.0 mEq/L before first dose of study drug - Has poorly controlled hyperthyroidism/hypothyroidism before first dose of study drug (confirmed by TSH or free thyroxine) - Has plans for adrenalectomy or adrenal nodulectomy - Has renal insufficiency (eGFR <30 mL/min/1.73m2) - Has liver test results >3x ULN (ALT or AST) or bilirubin >1.5x ULN - Takes drugs metabolized by CYP3A and CYP3A substrates with narrow therapeutic ranges - Receiving systemic corticosteroids that cannot be discontinued - Uses hormonal contraceptives - Has a history of unexplained vaginal bleeding, endometrial hyperplasia with atypia, or endometrial carcinoma - Is pregnant or lactating - Has a known hypersensitivity to mifepristone or any of the product components |
Country | Name | City | State |
---|---|---|---|
United States | Site 070 | Albany | New York |
United States | Site 074 | Ann Arbor | Michigan |
United States | Site 009 | Atlanta | Georgia |
United States | Site 097 | Atlanta | Georgia |
United States | Site 410 | Baltimore | Maryland |
United States | Site 067 | Boston | Massachusetts |
United States | Site 456 | Cedar Park | Texas |
United States | Site 181 | Chapel Hill | North Carolina |
United States | Site 436 | Cincinnati | Ohio |
United States | Site 042 | Cleveland | Ohio |
United States | Site 077 | Columbus | Ohio |
United States | Site 195 | Columbus | Ohio |
United States | Site 046 | Covington | Kentucky |
United States | Site 370 | Dallas | Texas |
United States | Site 444 | Edgewater | Florida |
United States | Site 407 | Escondido | California |
United States | Site 015 | Fort Lauderdale | Florida |
United States | Site 379 | Gardena | California |
United States | Site 435 | Grants Pass | Oregon |
United States | Site 378 | Huntington Park | California |
United States | Site 394 | Hyattsville | Maryland |
United States | Site 406 | La Jolla | California |
United States | Site 371 | Las Vegas | Nevada |
United States | Site 373 | Los Angeles | California |
United States | Site 408 | Lufkin | Texas |
United States | Site 061 | Metairie | Louisiana |
United States | Site 205 | New Orleans | Louisiana |
United States | Site 377 | New Orleans | Louisiana |
United States | Site 049 | Portland | Oregon |
United States | Site 054 | San Antonio | Texas |
United States | Site 369 | San Antonio | Texas |
United States | Site 405 | Seattle | Washington |
United States | Site 411 | Smithtown | New York |
United States | Site 387 | Tarzana | California |
United States | Site 375 | Torrance | California |
United States | Site 059 | Wilmington | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Corcept Therapeutics |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Part 1 Prevalence Phase: 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. | Screening | |
Primary | Part 2 Treatment Phase: Effect of Treatment on Hypercortisolism with Abnormal Adrenal CT Scan | Change in HbA1c from baseline (at randomization) to 24 weeks in patients with hypercortisolism and abnormal adrenal CT scan who have difficult to control T2D despite receiving standard of care therapies, treated with mifepristone versus placebo. | Baseline Day 1 to week 24 | |
Primary | Part 2 Treatment Phase: Effect of Treatment on Hypercortisolism without Abnormal Adrenal CT Scan | Change in HbA1c from baseline (at randomization) to 24 weeks in patients with hypercortisolism and normal adrenal CT scan who have difficult to control T2D despite receiving standard of care therapies, treated with mifepristone versus placebo. | Baseline Day 1 to week 24 | |
Secondary | Part 1 Prevalence Phase: Origin of Hypercortisolism | Percentage of patients with/without abnormal adrenal CT scan. | Screening | |
Secondary | Part 1 Prevalence Phase: Patient Characteristics | Clinical and/or laboratory characteristics of patients with hypercortisolism and of patients with hypercortisolism with/without abnormal adrenal CT scan. | Screening | |
Secondary | Part 2 Treatment Phase: Effect of Treatment | Change in anti-diabetes medication from baseline (at randomization) to 24 weeks in patients with hypercortisolism with/without abnormal adrenal CT scan who have difficult to control T2D despite receiving standard-of-care therapies, treated with mifepristone versus placebo. | Baseline Day 1 to week 24 | |
Secondary | Part 2 Treatment Phase: Effect of Treatment | Change from baseline (at randomization) to 24 weeks in body weight, body mass index, waist circumference, other glycemic metrics, blood pressure, quality of life, antihypertensive medications, etc. in patients with hypercortisolism with/without abnormal adrenal CT scan treated with mifepristone versus placebo. | Baseline Day 1 to week 24 |
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