Type 2 Diabetes study: Clofutriben
Official title Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)
ClinicalTrials.gov ID: NCT07296484
What this study is testing
What is clofutriben?
An investigational oral medication being studied for type 2 diabetes with elevated cortisol. It is designed to inhibit the enzyme 11‑hydroxysteroid dehydrogenase type 1 (HSD‑1).
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if clofutriben can lower cortisol in people with type 2 diabetes.
- Who it's for
- Adults with type 2 diabetes and risk factors for high cortisol.
- What's involved
- Participants first go through a screening visit to check their diabetes and cortisol levels. If eligible, they are randomly assigned to take either clofutriben or a placebo and will have follow‑up visits and tests during the treatment period.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 24 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- From Screening 1
- Age at least 18 years.
- HbA1c ≥7.5% documented within 3 months prior to Screening 1. (The historical HbA1c value must have been obtained after at least 2 months on the...
- Treatment with stable and adequate doses of ≥2 injectable or oral ADMs.
- Adequate total daily insulin is defined as at least 0.3 units/kg/day.
You likely can't join if
- New-onset diabetes (onset \<1 year in the past).
- Unwillingness to maintain with current glucose-lowering regimen during the trial.
- Unwillingness to adjust, add, replace, or discontinue current or other glucose-lowering medications during the trial as directed by the investigator.
- Unwillingness to comply with CGM or other trial procedures.
- Investigator considers the patient will otherwise be unwilling or unable to complete the trial.
- Night-shift worker or otherwise habitually awake from 23:00 to 07:00 h.
See the full eligibility criteria
Who can join
- From Screening 1
- Age at least 18 years.
- HbA1c ≥7.5% documented within 3 months prior to Screening 1. (The historical HbA1c value must have been obtained after at least 2 months on the current [as of Screening 1] regimen).
- Treatment with stable and adequate doses of ≥2 injectable or oral ADMs. (An ADM will be deemed stable if the dose has been the same for at least 3 months prior to Screening 1 and without change between Screening 1 and...
- Adequate total daily insulin is defined as at least 0.3 units/kg/day. Insulin dose will be deemed stable with adjustments of up to 20% total daily dose during the 3 months prior to Screening 1 or between Screening 1 and...
- Use of insulin pumps or insulin brand changes (e.g., due to insurance change or shortage) are to be discussed with the MM.
- At least one of the following
- ≥3 stable and adequate ADMs;
- diabetes complication (retinopathy, nephropathy, neuropathy, atherosclerotic heart disease);
- hypertension requiring ≥2 adequately dosed AHMs;
- adequately dosed basal or basal plus prandial insulin in addition to at least 1 other ADM; and
- adequately dosed incretin agonist (a single or combination agent counts as one ADM) in addition to at least 1 other ADM;
- evidence or history of osteoporosis or non-traumatic fracture (e.g., vertebral body compression);
- or established diagnosis of a neoplastic (non-malignant) source of hypercortisolism and have failed, are ineligible for, or declined surgery.
- HbA1c ≥7.5% at Screening 2. At Day 1
- No change in, or initiation of, medications for hypertension within 1 month prior to Day 1.
What rules you out
- New-onset diabetes (onset \<1 year in the past).
- Unwillingness to maintain with current glucose-lowering regimen during the trial.
- Unwillingness to adjust, add, replace, or discontinue current or other glucose-lowering medications during the trial as directed by the investigator.
- Unwillingness to comply with CGM or other trial procedures.
- Investigator considers the patient will otherwise be unwilling or unable to complete the trial.
- Night-shift worker or otherwise habitually awake from 23:00 to 07:00 h.
- Evidence for significant hypoglycemia while on their current diabetic treatment regimen(This includes episodes of symptomatic Level 3 hypoglycemia requiring external assistance for recovery, or CGM-documented prolonged...
- Type 1 diabetes mellitus (T1D), latent autoimmune diabetes in adults (LADA), or familial forms of maturity-onset diabetes of the young (MODY);
- A hemoglobinopathy or other condition which may interfere with measurement of HbA1c (e.g., sickle cell disease HbSS or other variants HbEE thalassemia, hemolytic anemia, recent blood transfusion);
- Hypersensitivity or severe reaction to dexamethasone;
- Pheochromocytoma, or suspicion thereof;
- Anorexia, or other eating disorder;
- Glucocorticoid resistance;
- Multiple sclerosis;
- Significant hepatic impairment (e.g., Child-Pugh Class B or C);
- Idiopathic thrombocytopenic purpura;
- Untreated or inadequately controlled moderate-to-severe sleep apnea (apnea-hypopnea index ≥15). (Patients whose condition has been well controlled with Continuous Positive Airway Pressure (CPAP) use for at least 3...
- Current alcohol consumption \>14 units/week or \>4 units in a single day for males, or \>7 units/week or \>3 units in a single day for females.
- Untreated or inadequately controlled major depressive disorder, generalized anxiety disorder, bipolar disorder, post-traumatic stress disorder, or schizophrenia.(Patients whose condition has been well controlled with...
- Any other medical condition (including malignancy) that is likely to interfere with trial assessments or the patient's ability to complete the trial.
- Any of the excluded medications listed in Section 6.9;
- Any investigational drug within 4 weeks or within less than five times the drug's half-life, whichever is longer, prior to Screening 1 or between Screening 1 and Day 1;
- Woman of childbearing potential (WOCBP) not willing to adhere to highly effective contraception or strict abstinence for the duration of the trial and for 90 days post completion/discontinuation; and
- Pregnancy (including a positive urine test) or current breast feeding. From Screening 2
- wo morning serum cortisol values after dexamethasone suppression \>5.0 mcg/dL together with plasma dexamethasone \>140 ng/mL; or
- supraclavicular/dorsocervical fat accumulation;
- irounding of the face (especially compared with prior photos);
- skin changes (violaceous striae, skin thinning, or excessive bruising);
- proximal muscle weakness on exam; or
- history of deep vein thrombosis/pulmonary embolism.
- Plans for, or medically unable to forego, treatment for endogenous Cushing syndrome or ACS within the next 8 months.
- Severe, poorly controlled hypertension (mean systolic BP \>160 mmHg or mean diastolic BP \>100 mmHg) at Screening 2 or between Screening 2 and Day 1, including by at-home monitoring.
- Positive urine screen for recreational drugs (except tetrahydrocannabinol (THC)).
- Glomerular filtration rate (GFR) (determined using Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI]) \<45 mL/min/1.73 m².
- Poorly controlled hyperthyroidism/hypothyroidism (confirmed by TSH or Free thyroxine [fT4]).
- Liver enzymes \>3 × upper limit of normal (ULN) (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or bilirubin \>1.5 × ULN.(excepting benign conditions such as Gilbert's)
- Known hypersensitivity to clofutriben or to any of the product
The study team makes the final eligibility decision.
Where it is enrolling
- Chandler, Arizona, United States
- Tucson, Arizona, United States
- Fountain Valley, California, United States
- Huntington Park, California, United States
- La Mesa, California, United States
- Long Beach, California, United States
- Los Angeles, California, United States
- Northridge, California, United States
- San Diego, California, United States
- Edgewater, Florida, United States
- Fort Lauderdale, Florida, United States
- Miami, Florida, United States
- New Port Richey, Florida, United States
- Port Charlotte, Florida, United States
- Port Orange, Florida, United States
- Winter Park, Florida, United States
- Atlanta, Georgia, United States
- Columbus, Georgia, United States
- Boise, Idaho, United States
- Chicago, Illinois, United States
+ 36 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 24 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Chandler, Arizona, United States; Tucson, Arizona, United States; Fountain Valley, California, United States; Huntington Park, California, United States; La Mesa, California, United States; Long Beach, California, United States and 50 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.