The refractory Cushing syndrome and subclinical Cushing syndrome.
Conditions
Interventions
Oral administration of 200mg of 11beta-HSD1 inhibitor after dinner once a day for 12 weeks. After confirming the safety of the study, oral administration continues further 12 weeks. In case of the sub
Sponsors
Kyushu University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Include the patients who match the following 8 criteria. 1) The patients with the age of 18 y ears old or more. 2) The patients diagnosed with the refractory Cushing syndrome or the subclinical Cushing syndrome. 3) The patients with impaired glucose tolerance or type 2 diabetes who are treated with alpha glucosidase inhibitor or diet exercise therapy. 4) The patients with HbA1c in the screening test less than 8.0 percent and with no change in the diabetes drug for at least 2 M prior to the study. 5) The patient who are capable of oral administration of the drug. 6) In case of men, the patients who agree to contraception or diagnosed with azoospermia. 7) In case of women, the patients who agree to contraception or diagnosed with infertility. 8) The patients who written consent has been obtained.
Exclusion criteria
Exclusion criteria: Exclude the patients who correspond to any of the following 12 criteria. 1) Patients with sever heart or blood diseases. 2) Patient with a high degree of renal dysfunction (eGFR<30mL/min/1.73 m2) 3) Patients with liver dysfunction (AST or ALT> 3x Upper limit ) 4) Patients with acute or chronic infection that require treatment. 5) Patients with autoimmune or allergy diseases that require treatment. 6) Patients with present or a history of less than 5 years of malignancy with exception of ectopic ACTH syndrome. 7) Patients receiving metyrapone or trilostane within 1 week or mitotane within 3 months before first dose of 11beta-HSD1 inhibitor. 8) Patients with a history of drug allergies that interfere with participation in the clinical trial. 9) Patients with mental illness or its history that interfere with participation in the clinical trial. 10) Pregnant women, nursing mothers, or patients who do not agree to contraception during study period. 11) Patients participating in other clinical trial or clinical research and receiving the drug within 30 days before obtaining informed consent. 12) Patients who are deemed to be inappropriate by investigator or sharing physician from a medical point of view.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the response rate in AUCglucose during oral glucose tolerance test at Week 24. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the percent change from baseline in AUCglucose during oral glucose tolerance test at Week 24. To assess the response rate and percent change from baseline in AUCglucose during oral glucose tolerance test at Week 12. To assess the absolute and percent change from baseline in the following values. Blood cortisol concentration, Urine cortisol, Salivary cortisol concentration, HbA1c, HOMA-IR, Diastolic and systolic blood pressure | — |
Countries
Japan
Contacts
Public ContactKenji Ashida
Kyushu University Hospital Department of endocrine, metabolism and diabetes
Outcome results
None listed