Mifepristone for Type 2 Diabetes

Recruiting at 35 trial locations

Overseen By Clinical Trial Lead

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Corcept Therapeutics

Must be taking: Anti-hyperglycemics, Insulin

Must not be taking: Systemic glucocorticoids, Hormonal contraceptives

Disqualifiers: Type 1 diabetes, Pregnancy, Severe psychiatric illness, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

1113 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing mifepristone, a medication that blocks cortisol, in patients with hard-to-control type 2 diabetes and high cortisol levels. The goal is to see if mifepristone can help manage their blood sugar better than standard treatments alone. Mifepristone has been studied for various conditions including Cushing's syndrome, psychotic depression, and cognitive decline in Alzheimer's disease.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current diabetes medications, but you should not change or start new diabetes medications within 4 weeks before the study drug. Women on oral contraceptives must stop them for at least 3 weeks before a specific test.

How does the drug Mifepristone differ from other treatments for type 2 diabetes?

Mifepristone is unique because it is primarily known for its use in other conditions, such as Cushing's syndrome and as an abortifacient, rather than for type 2 diabetes. Its mechanism of action involves blocking the effects of cortisol, a stress hormone, which is different from most diabetes medications that focus on insulin regulation or sensitivity. ^{1 2 3 4 5}

Who Is on the Research Team?

Daniel Einhorn, MD

Principal Investigator

Corcept Therapeutics

Are You a Good Fit for This Trial?

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.

Inclusion 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 am on 2 or more diabetes drugs and have complications or high blood pressure needing 2 or more medications.

Exclusion Criteria

Has severe medical or surgical illness as judged by the Investigator

Is pregnant or lactating

I haven't taken steroid pills or injections in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prevalence Phase

Non-interventional phase to assess the prevalence of hypercortisolism in patients with difficult to control type 2 diabetes

Screening

1 visit (in-person)

Treatment Phase

Randomized, placebo-controlled trial to assess the safety and efficacy of mifepristone treatment in patients with hypercortisolism

24 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mifepristone
• Placebo for Mifepristone

Trial Overview 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.

How Is the Trial Designed?

Group I: Mifepristone 300 mg Experimental Treatment 1 Intervention

Randomized to receive 300 mg mifepristone, titrated to 600 mg mifepristone after 4 weeks with an opportunity to increase to 900 mg mifepristone at week 8 or 12

Group II: Placebo Placebo Group 1 Intervention

Patients who meet the entry criteria for the Study C-1073-310 will be randomized to receive placebo for 24 weeks

Mifepristone is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Mifeprex for:

• Abortion
• Cushing's Syndrome

Approved in European Union as Mifegyne for:

• Abortion
• Cushing's Syndrome

Approved in Canada as Mifeprex for:

• Abortion
• Cushing's Syndrome

Who Is Running the Clinical Trial?

Corcept Therapeutics

Lead Sponsor

Trials

72

Recruited

7,700+

Dr. Joseph K. Belanoff

Corcept Therapeutics

Chief Executive Officer since 2014

MD from Stanford University

Dr. William Guyer

Corcept Therapeutics

Chief Medical Officer since 2021

PharmD

Citations

1. Italy pubmed.ncbi.nlm.nih.gov

Repaglinide in combination therapy. [2018]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Repaglinide. [2018]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Meglitinide analogues in the treatment of type 2 diabetes mellitus. [2018]

4. England pubmed.ncbi.nlm.nih.gov

[symbol: see text] Nateglinide and [symbol: see text] repaglinide for type 2 diabetes? [2018]

5. Germany pubmed.ncbi.nlm.nih.gov

[Antidiabetic drug at every meal. Repaglinide is especially recommended for slender type 2 diabetic patients]. [2014]