What side effects are associated with this type of intervention?

Mifepristone, a glucocorticoid receptor antagonist used to treat Cushing's Syndrome, commonly causes side effects such as fatigue, nausea, headache, and hypokalemia (low potassium levels). Women may experience endometrial thickening and irregular menstrual cycles. There is also a risk of adrenal insufficiency due to excessive blockade of cortisol action. Monitoring these side effects is crucial during treatment.

What prior FDA approvals exist?

Mifepristone (Korlym) is an FDA-approved glucocorticoid receptor antagonist used to treat Cushing's Syndrome, particularly in patients with type 2 diabetes or glucose intolerance. Another FDA-approved drug for Cushing's Syndrome is pasireotide (Signifor), a somatostatin analog that inhibits ACTH secretion. These treatments help manage hypercortisolism by different mechanisms, with mifepristone blocking cortisol's effects at the receptor level and pasireotide reducing cortisol production.

What other types of research exist?

Promising novel alternatives to Mifepristone for Cushing's Syndrome patients include Osilodrostat, a cortisol synthesis inhibitor, and Levoketoconazole, another cortisol synthesis inhibitor. Both have shown efficacy in reducing cortisol levels and improving clinical symptoms in recent studies and clinical trials.

← Back to Search

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

Must not have

Systemic glucocorticoid medications exposure (excluding inhalers or topical) within 3 months of screening

Has type 1 diabetes mellitus

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline day 1 to week 24

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

Summary

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.

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.

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.

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 below

Select...

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

I have type 1 diabetes.

Select...

I have severe sleep apnea that hasn't been treated.

Select...

I am on hemodialysis or have end-stage kidney disease.

Select...

I have been diagnosed with Cushing syndrome or plan to treat it.

Select...

I was diagnosed with diabetes within the last year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline day 1 to week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline day 1 to week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline day 1 to week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part 1 Prevalence Phase: Prevalence of Hypercortisolism

Part 2 Treatment Phase: Effect of Treatment on Hypercortisolism with Abnormal Adrenal CT Scan

Part 2 Treatment Phase: Effect of Treatment on Hypercortisolism without Abnormal Adrenal CT Scan

Secondary study objectives

Part 1 Prevalence Phase: Origin of Hypercortisolism

Part 1 Prevalence Phase: Patient Characteristics

Part 2 Treatment Phase: Effect of Treatment

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Mifepristone 300 mgExperimental Treatment1 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: PlaceboPlacebo Group1 Intervention

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

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cushing's Syndrome is characterized by excessive cortisol levels, leading to various metabolic disturbances. Mifepristone, a glucocorticoid receptor antagonist, works by blocking the effects of cortisol at the receptor level, thereby mitigating the symptoms without reducing cortisol production. This is crucial for patients as it helps manage hyperglycemia and other cortisol-related symptoms. Other treatments include ketoconazole and metyrapone, which inhibit cortisol synthesis, and pasireotide, which reduces ACTH secretion. These treatments are essential for controlling the excessive cortisol levels and improving the quality of life for patients with Cushing's Syndrome.