Type 2 Diabetes MellitusPhase 2NCT03052400
Efficacy of Mifepristone in Males With Type 2 Diabetes Mellitus
A Phase 2 study testing Mifepristone 600 mg daily in people with Type 2 Diabetes Mellitus and Insulin Resistance, run by Charles Drew University of Medicine and Science at 1 site in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Type 2 Diabetes Mellitus, Insulin Resistance
- What is being tested?
- Mifepristone 600 mg daily
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2017to 31 May 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Charles Drew University of Medicine and Science
Los Angeles, California, 90059
About this study
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
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus, Insulin Resistance
- Being tested
- Mifepristone 600 mg daily, Placebo
- Keywords
- type 2 diabetes mellitus, insulin resistance, mifepristone, glucocorticoids
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mifepristone 600 mg dailyDrug
Also called Korlym
Glucocorticoid receptor antagonist
PlaceboDrug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Mifepristone 600 mg daily | Experimental | Mifepristone 300 mg po daily x 2 weeks, followed by mifepristone 600 mg po daily x 10 weeks Receives: Drug: Mifepristone 600 mg daily |
| Placebo | Placebo comparator | Matching, blinded placebo 1 tablet po daily x 2 weeks, followed by matching, blinded placebo 2 tablets po daily x 10 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c
Glycemic lowering
Measured: Baseline to 3 months
Secondary outcomes (12)
Weight
Weight in kg
Measured: Baseline to 3 months
Body Mass Index
Body mass index in kg/m^2
Measured: Baseline to 3 months
Systolic BP
Systolic blood pressure
Measured: Baseline to 3 months
Diastolic BP
Diastolic blood pressure
Measured: Baseline to 3 months
LDL-cholesterol
Low-density lipoprotein cholesterol
Measured: Baseline to 3 months
Cortisol
Serum cortisol level (AM)
Measured: Baseline to 3 months
ACTH
Serum adrenocorticotrophic hormone level (AM)
Measured: Baseline to 3 months
Uric Acid
Serum uric acid level
Measured: Baseline to 3 months
PSA
Prostate-specific antigen level
Measured: Baseline to 3 months
Hypoglycemic Events
Symptomatic mild and severe hypoglycemic events
Measured: Baseline to 3 months
Adverse Events
Non-hypoglycemia-related adverse events
Measured: Baseline to 3 months
Basal Insulin Dose
Total daily basal insulin dosage
Measured: Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study start3 Feb 2017
- Primary completion31 Mar 2021
- Study completion31 May 2021
Why it stopped: End of Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles Drew University of Medicine and Science
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stanley Hsia, Charles Drew University of Medicine and Science
- Investigators
- Stanley H Hsia, MD, Principal investigator, Charles Drew University of Medicine and Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03052400
- Sponsor's protocol ID
- 16-04-2482
- Status last verified
- Apr 2023
- First submitted
- 8 Feb 2017
- Last updated
- 18 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sharing as per NIH funding requirements
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Mifepristone in Males With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03052400
- Acronym / sponsor ID
- 16-04-2482
- Conditions
- Type 2 Diabetes Mellitus, Insulin Resistance
- Keywords
- type 2 diabetes mellitus, insulin resistance, mifepristone, glucocorticoids
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: End of Funding
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Charles Drew University of Medicine and ScienceUniversity, hospital or other
- Study start
- 3 Feb 2017 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 14 Feb 2017 (actual)
- Results
- Posted 19 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mifepristone 600 mg daily | Experimental | Drug: Mifepristone 600 mg dailyMifepristone 300 mg po daily x 2 weeks, followed by mifepristone 600 mg po daily x 10 weeks |
| Placebo | Placebo comparator | Drug: PlaceboMatching, blinded placebo 1 tablet po daily x 2 weeks, followed by matching, blinded placebo 2 tablets po daily x 10 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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%
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mifepristone 600 mg dailyAlso: KorlymGlucocorticoid receptor antagonist | Drug | Mifepristone 600 mg daily |
| PlaceboMatching placebo | Drug | Placebo |
Primary outcome
Hemoglobin A1c
Time frame: Baseline to 3 months
Glycemic lowering
12 secondary outcomes
Weight
Time frame: Baseline to 3 months
Body Mass Index
Time frame: Baseline to 3 months
Systolic BP
Time frame: Baseline to 3 months
Diastolic BP
Time frame: Baseline to 3 months
LDL-cholesterol
Time frame: Baseline to 3 months
Cortisol
Time frame: Baseline to 3 months
ACTH
Time frame: Baseline to 3 months
Uric Acid
Time frame: Baseline to 3 months
PSA
Time frame: Baseline to 3 months
Hypoglycemic Events
Time frame: Baseline to 3 months
Adverse Events
Time frame: Baseline to 3 months
Basal Insulin Dose
Time frame: Baseline to 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Data sharing as per NIH funding requirements
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stanley H Hsia, MD principal investigator
Charles Drew University of Medicine and Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mifepristone 600 mg daily in people with Type 2 Diabetes Mellitus and Insulin Resistance, run by Charles Drew University of Medicine and Science at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin A1c (time frame: Baseline to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2023; AzTrials last refreshed its copy on 8 Nov 2026.