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