Mifepristone for Type 2 Diabetes

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of mifepristone, a medication, for individuals with type 2 diabetes that remains difficult to manage despite standard treatments. The first part examines the prevalence of hypercortisolism in those with hard-to-control diabetes. The second part compares mifepristone to a placebo to determine its effectiveness for individuals with both hypercortisolism and challenging diabetes. Individuals with type 2 diabetes that is hard to control and who are on multiple diabetes medications might be suitable candidates. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective treatment can benefit more patients.

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.

What is the safety track record for mifepristone?

Research has shown that mifepristone is approved for managing blood sugar in adults with high cortisol levels, a condition known as hypercortisolism. This approval indicates a degree of safety. In studies, some participants experienced side effects such as low potassium levels, tiredness, nausea, vomiting, headaches, swelling, and diarrhea. Serious side effects occurred in 31.9% of patients taking mifepristone, compared to 4.7% of those taking a placebo. While mifepristone can help control blood sugar, potential side effects should be considered when deciding to join the trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about mifepristone for type 2 diabetes because it offers a novel approach compared to traditional treatments like metformin or insulin. Unlike these standard options, which primarily focus on managing blood sugar levels through insulin sensitivity or direct insulin supplementation, mifepristone works by blocking the glucocorticoid receptor. This action can potentially influence glucose metabolism differently, offering a new pathway to manage diabetes. Its unique method of action might help patients who do not respond well to existing therapies, providing hope for more personalized diabetes care.

What evidence suggests that mifepristone might be an effective treatment for type 2 diabetes?

Research has shown that mifepristone, which participants in this trial may receive, can help control blood sugar levels in people with difficult-to-manage type 2 diabetes. In studies, mifepristone improved blood sugar levels (measured by HbA1c) by 2.01%, while those taking a placebo experienced only a small drop of 0.16%. It also aided in weight loss, with patients losing an average of 5.12 kg more than those on a placebo. Other benefits included a smaller waist size and better overall blood sugar control. These findings suggest that mifepristone can be effective for people with type 2 diabetes who also have hypercortisolism, a condition characterized by excessive levels of the stress hormone cortisol. ^{2 3 4 5 6}

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. diabetes.org diabetes.org/newsroom/press-releases/mifepristone-shown-reduce-a1c-patients-difficult-control-type-2-diabetes

Mifepristone Shown to Reduce A1C in Patients with ... New findings from the CATALYST study show that the use of mifepristone resulted in improved blood glucose (blood sugar) control and weight ...

2. diabetesjournals.org diabetesjournals.org/care/article/doi/10.2337/dc25-1055/160651/Inadequately-Controlled-Type-2-Diabetes-and

Inadequately Controlled Type 2 Diabetes and Hypercortisolism Participants receiving mifepristone experienced reductions in body weight and waist circumference (placebo-adjusted LSM differences of −5.12 kg ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11253743/

prevalence and treatment with mifepristone - PubMed Central Studies indicate that in >10% of individuals with difficult-to-control T2D, hypercortisolism may be an underlying contributing cause.

4. ir.corcept.com ir.corcept.com/news-releases/news-release-details/corcept-presents-data-treatment-phase-catalyst-trial-american

Corcept Presents Data from Treatment Phase of CATALYST ... Patients who received 900mg of Korlym had an improvement in HbA1c of 2.01 percent, compared to a 0.16 percent decrease in patients who received ...

5. clinicaladvisor.com clinicaladvisor.com/news/mifepristone-improves-glycemia-in-t2d-plus-hypercortisolism/

Mifepristone Improves Glycemia in T2D Plus ... Mifepristone was associated with improved glycemia, body weight reduction, and BMI among patients with type 2 diabetes and hypercortisolism.

6. korlym.com korlym.com/hcp/safety

Safety and Adverse Events - Korlym® (mifepristone) HCP CATALYST safety data · 31.9% of patients treated with Korlym and 4.7% of patients treated with placebo experienced a serious TEAE · 28.6% of patients treated with ...