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Corticosteroid
Mifepristone for Type 2 Diabetes
Phase 4
Recruiting
Research Sponsored by Corcept Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Taking insulin and other anti-hyperglycemic drugs.
Has difficult to control T2D (HbA1c ≥7.5% and ≤11.5%) based on HbA1c performed at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline day 1 to week 24
Awards & highlights
Study Summary
This trial studies how a drug (mifepristone) affects people with difficult to control type 2 diabetes. It looks at safety and effectiveness.
Who is the study for?
This trial is for adults with type 2 diabetes that's hard to control (HbA1c between 7.5% and 11.5%) despite using insulin or multiple diabetes drugs, who may also have high blood pressure or complications like heart disease, kidney issues, or nerve damage. It's not for those with type 1 diabetes, recent use of experimental drugs, night shift workers, history of Cushing syndrome treatment, new-onset diabetes under a year old, severe reactions to dexamethasone, recent systemic steroid use (except inhalers/topical), untreated severe sleep apnea, heavy alcohol users as defined by the study criteria.Check my eligibility
What is being tested?
The study has two parts: first checking how common hypercortisolism is in people whose type 2 diabetes isn't well-controlled by standard treatments; second testing if Mifepristone (Korlym) can safely and effectively manage their condition compared to a placebo. Participants will be randomly assigned to either receive Korlym or a placebo without knowing which one they're getting.See study design
What are the potential side effects?
Mifepristone may cause side effects such as fatigue, nausea and vomiting, headache and dizziness. Some individuals might experience endocrine changes like low potassium levels or vaginal bleeding in women.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am taking insulin and other medications to lower my blood sugar.
Select...
My diabetes is hard to manage with my HbA1c between 7.5% and 11.5%.
Select...
I am on 2 or more diabetes drugs and have complications or high blood pressure needing 2 or more medications.
Select...
I am taking insulin and other medications to lower my blood sugar.
Select...
I am taking three or more medications for diabetes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ screening
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Prevalence of Hypercortisolism
Secondary outcome measures
Effect of Treatment on Neoplastic Hypercortisolism
Effect of Treatment on Non-neoplastic Hypercortisolism
Side effects data
From 2016 Phase 4 trial • 8 Patients • NCT0199056013%
Drug Rash
13%
Hypokalemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Mifepristone
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Mifepristone 300 mgExperimental Treatment1 Intervention
Patients who meet the entry criteria for the Study C-1073-310 will be randomized to receive 600 mg mifepristone for 24 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Patients who meet the entry criteria for the Study C-1073-310 will be randomized to receive placebo for 24 weeks.
Find a Location
Who is running the clinical trial?
Corcept TherapeuticsLead Sponsor
68 Previous Clinical Trials
5,380 Total Patients Enrolled
7 Trials studying Cushing's Syndrome
171 Patients Enrolled for Cushing's Syndrome
Daniel Einhorn, MDStudy DirectorCorcept Therapeutics
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am taking insulin and other medications to lower my blood sugar.My diabetes is hard to manage with my HbA1c between 7.5% and 11.5%.I haven't taken steroid pills or injections in the last 3 months.I have type 1 diabetes.I have severe sleep apnea that hasn't been treated.I am on hemodialysis or have end-stage kidney disease.You have a serious mental illness like schizophrenia or dementia.I am on 2 or more diabetes drugs and have complications or high blood pressure needing 2 or more medications.I am taking insulin and other medications to lower my blood sugar.You work the late shift and are usually awake from 11 PM to 7 AM.I am taking three or more medications for diabetes.I have been diagnosed with Cushing syndrome or plan to treat it.I was diagnosed with diabetes within the last year.You have had a bad reaction to dexamethasone in the past.You drink more alcohol than what is considered safe for your gender.
Research Study Groups:
This trial has the following groups:- Group 1: Mifepristone 300 mg
- Group 2: Placebo
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the highest capacity of participants that can join this clinical trial?
"Affirmative. According to the clinicaltrials.gov page, this experiment is currently recruiting volunteers for participation. It was initially posted on March 31st 2023 and revised as recently as April 6th 2023; 1000 individuals are being sought from 2 different sites."
Answered by AI
What negative impacts could arise from taking Mifepristone 300 mg?
"A score of 3 was assigned to Mifepristone 300 mg's safety as it has been approved by the fourth stage of trials, meaning there is substantial evidence demonstrating its efficacy."
Answered by AI
Are geriatric individuals being included in this trial?
"As per the criteria for enrolment in this medical trial, participants must be at least 18 years old but can not exceed 80."
Answered by AI
Are there any remaining openings in this clinical trial for participants?
"As per the details posted on clinicaltrials.gov, this trial is currently enlisting willing participants. The original posting date was March 31st 2023 and it has been updated as recently as April 6th 2023."
Answered by AI
Does my profile qualify me for participation in this medical experiment?
"Eligibility criteria for this research stipulates that type 2 diabetes patients who are between 18 and 80 years old can participate. A total of 1000 individuals will be recruited for the trial."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
Site 379
Site 375
Site 097
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
3+
Why did patients apply to this trial?
I have tried different kinds of medication 💊 to control my diabetes or get rid of my diabetes for good?
PatientReceived no prior treatments
I have difficulty controlling my diabetes. I have tried 3 other medications but each has had either a side effect I could not tolerate or just didn't seem to work.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
I would like to know how long is the trials and what does it consist of medication 💊?
PatientReceived no prior treatments
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