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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1,113
Mifepristone tablets for once daily oral dosing
Placebo tablets for once daily oral dosing
Site 407
Escondido, California, United States
Site 379
Gardena, California, United States
Site 378
Huntington Park, California, United States
Site 406
La Jolla, California, United States
Site 373
Los Angeles, California, United States
Site 387
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline Day 1 to week 24
Part 1 Prevalence Phase: Origin of Hypercortisolism
Percentage of patients with/without abnormal adrenal CT scan.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline Day 1 to week 24
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Tarzana, California, United States
Site 375
Torrance, California, United States
Site 444
Edgewater, Florida, United States
Site 015
Fort Lauderdale, Florida, United States
Site 009
Atlanta, Georgia, United States
...and 26 more locations