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Trial record 32 of 52 for:    cushing's | Recruiting, Not yet recruiting, Available Studies

Efficacy of Mifepristone in Males With Type 2 Diabetes Mellitus

This study is currently recruiting participants.
Verified November 2017 by Stanley Hsia, Charles Drew University of Medicine and Science
Sponsor:
ClinicalTrials.gov Identifier:
NCT03052400
First Posted: February 14, 2017
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Stanley Hsia, Charles Drew University of Medicine and Science
  Purpose
Randomized, double blind, placebo-controlled clinical trial examining the efficacy and safety of mifepristone 600 mg daily in male subjects with type 2 diabetes mellitus, not associated with Cushing's syndrome

Condition Intervention Phase
Type 2 Diabetes Mellitus Insulin Resistance Drug: Mifepristone 600 mg daily Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Mifepristone in Males With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Stanley Hsia, Charles Drew University of Medicine and Science:

Primary Outcome Measures:
  • Hemoglobin A1c [ Time Frame: 3 months ]
    Glycemic lowering


Secondary Outcome Measures:
  • Weight [ Time Frame: 3 months ]
    Weight in kg

  • Body mass index [ Time Frame: 3 months ]
    BMI in kg/m2

  • Fat mass [ Time Frame: 3 months ]
    Percentage total body fat mass

  • Lean body mass [ Time Frame: 3 months ]
    Percentage total body lean mass

  • Insulin resistance [ Time Frame: 3 months ]
    HOMA and OGTT dynamic measures

  • Fasting lipids [ Time Frame: 3 months ]
    Fasting lipids and lipoproteins

  • Blood pressure [ Time Frame: 3 months ]
    Systolic and diastolic BP

  • Hypoglycemic events [ Time Frame: 3 months ]
    Symptomatic mild and severe hypoglycemic events

  • Adverse events [ Time Frame: 3 months ]
    Non-hypoglycemia-related adverse events

  • Insulin dose [ Time Frame: 3 months ]
    Total daily insulin dosage


Estimated Enrollment: 60
Actual Study Start Date: February 3, 2017
Estimated Study Completion Date: May 2020
Estimated Primary Completion Date: May 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mifepristone 600 mg daily
Mifepristone 300 mg po daily x 2 weeks, followed by mifepristone 600 mg po daily x 10 weeks
Drug: Mifepristone 600 mg daily
Glucocorticoid receptor antagonist
Other Name: Korlym
Placebo Comparator: Placebo
Matching, blinded placebo 1 tablet po daily x 2 weeks, followed by matching, blinded placebo 2 tablets po daily x 10 weeks
Drug: Placebo
Matching placebo

Detailed Description:
Randomized, double blind, placebo-controlled clinical trial examining the efficacy and safety of mifepristone 600 mg daily in male subjects with type 2 diabetes mellitus, not associated with Cushing's syndrome, and sub-optimally controlled on basal insulin, with or without prandial insulin and/or maximally-tolerated doses of metformin.
  Eligibility

Information from the National Library of Medicine

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 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria
  • Males
  • Age 18-65 inclusive
  • Established T2DM for ≥ 1 year
  • Taking stable doses (≤ 20% change in total daily insulin dose within 2 months prior to screening) of basal insulin, with or without prandial insulin (total daily dose must be ≤ 200 units)
  • Baseline hemoglobin A1c (HbA1c) 8.0%-10.5%
  • No use of any anti-hyperglycemic agents (oral or injectable) other than metformin or insulin
  • No history or clinical suspicion of type 1 diabetes mellitus
  • No concurrent chronic use of any corticosteroids by any route and for any indication, or concurrent conditions that may require the initiation of glucocorticoids during the study
  • No concurrent lipid-lowering medications whose levels are dependent on CYP3A pathway clearance (e.g., simvastatin, lovastatin, atorvastatin, fluvastatin and rosuvastatin) should either be washed out for at least one month prior to enrollment and/or switched to alternative LDL-cholesterol lowering agents (e.g., pravastatin or ezetimibe) for at least one month.
  • No contraindications or known intolerance to mifepristone
  • No concurrent use of strong CYP3A inhibitors (e.g., cyclosporine, ergotamine, fentanyl, quinidine, sirolimus, tacrolimus, imidazole antifungals, HIV protease inhibitors, certain macrolide antibiotics)
  • No concurrent use of CYP3A inducers (e.g., phenytoin, phenobarbital, carbamazepine, rifampin)
  • No concurrent use of medications that may prolong the QT interval (e.g., selected antipsychotics and antidepressants, quinolone antibiotics)
  • No daily use of warfarin or non-steroidal anti-inflammatory agents
  • Baseline K+ and Mg+2 within the laboratory normal ranges, with or without oral K+ and/or Mg+2 supplementation
  • Fasting plasma glucose (FPG) averaging < 280 mg/dL and without polyuria or polydipsia
  • No symptomatic hypoglycemia averaging > once per day
  • Able and willing to perform self-monitoring of blood glucose (SMBG)
  • Mean BP < 140 mmHg systolic or 90 mm Hg diastolic
  • Baseline LDL-cholesterol < 200 mg/dL if on lipid-lowering therapy or < 250 mg/dL while not on lipid-lowering therapy
  • Fasting triglycerides ≤ 500 mg/dL if on lipid-lowering therapy
  • HDL-cholesterol ≥ 25 mg/dL
  • No known history of prostate cancer, or elevated level of prostate-specific antigen (PSA) at screening
  • Estimated GFR ≥ 30 mL/min
  • No concurrent endocrinopathies that have not been stabilized with replacement or other definitive therapies (including known adrenal insufficiency regardless of replacement therapy, cortisol < 5 μg/dL at screening)
  • No active hemolytic anemias or hemoglobin variants that render the measurement of HbA1c potentially unreliable
  • No other clinically significant hepatic, cardiovascular (including known personal or family history of, or risk factors for long-QT syndrome, QTcF prolongation on ECG > 500 ms), infectious (including HIV or any viral hepatitis), inflammatory, neoplastic or other systemic disease that may contraindicate the change of lipid-lowering therapy, renders mifepristone unsafe, or otherwise confounds data interpretation
  • Subjects not likely to start other drugs that may influence the study's outcomes (e.g., weight loss agents)
  • Subjects who are able and willing to comply with all components of the study protocol, attend all scheduled follow-up visits, or who do not present other foreseeable barriers that might make the implementation of the protocol problematic or confound data interpretation
  Contacts and Locations
Information from the National Library of Medicine

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): NCT03052400


Contacts
Contact: Petra Duran 323-357-3428 petraduran@cdrewu.edu
Contact: Stanley H Hsia, MD 323-357-3633 stanleyhsia@cdrewu.edu

Locations
United States, California
Charles Drew University of Medicine and Science Recruiting
Los Angeles, California, United States, 90059
Contact: Stanley H Hsia, MD    323-357-3633    stanleyhsia@cdrewu.edu   
Principal Investigator: Stanley Hsia, MD         
Sponsors and Collaborators
Charles Drew University of Medicine and Science
Investigators
Principal Investigator: Stanley H Hsia, MD Charles Drew University of Medicine and Science
  More Information

Responsible Party: Stanley Hsia, Associate Professor of Medicine, Charles Drew University of Medicine and Science
ClinicalTrials.gov Identifier: NCT03052400     History of Changes
Other Study ID Numbers: 16-04-2482
First Submitted: February 8, 2017
First Posted: February 14, 2017
Last Update Posted: November 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data sharing as per NIH funding requirements

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Stanley Hsia, Charles Drew University of Medicine and Science:
type 2 diabetes mellitus
insulin resistance
mifepristone
glucocorticoids

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
Glucocorticoids
Mifepristone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents